An interventional study of Eversense XL CGM System and Usual SMBG or FGM device used by participants in Diabetes Mellitus, sponsored by Hoffmann-La Roche. Completed at 20 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-10.
Sponsored by Hoffmann-La Roche · Not applicable, Interventional, and Diagnostic
This study will be conducted in France and will evaluate the usefulness of using a long-term subcutaneously inserted continuous glucose monitoring (CGM) sensor (the Eversense XL CGM System) to improve glycemic control in patients with either Type 1 or Type 2 diabetes mellitus under insulin therapy. Participants will be enrolled into one of two cohorts (Cohorts 1 and 2). Cohort 1 will be focused on participants with Type 1 or Type 2 diabetes with hemoglobin A1C (HbA1c) >8%. Cohort 2 will be focused on participants with Type 1 diabetes spending more than 1.5 hours per day with mean glucose \<70 mg/dL, including excursions below 54 mg/dL, for at least 28 days. Within each cohort, participants will be randomized in a 2:1 ratio to one of two groups: the Enabled and Control groups, respectively. The Enabled group will be trained to use the CGM system, whereas the Control group will continue with their usual glucose monitoring system (self-monitoring of blood glucose [SMBG] or flash glucose monitoring [FGM]).
Exclusion Criteria:
Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.
Device: Eversense XL CGM System
Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.
Device: Eversense XL CGM System · Device: Usual SMBG or FGM device used by participants
Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.
Device: Eversense XL CGM System
Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.
Device: Eversense XL CGM System · Device: Usual SMBG or FGM device used by participants
The Eversense XL Continuous Glucose Monitoring (CGM) System consists of an implantable sensor inserted under the skin, an external transmitter, and a Mobile Medical Application (MMA) for display of glucose information that runs on a Handheld Device (HHD).
Commercially available products in France for self-monitoring of blood glucose (SMBG) or flash glucose monitoring (FGM) were considered as comparators for this study.
Cohort 1: HbA1c (%) Levels at Day 180
The analysis of the primary outcome measure for Cohort 1 was an analysis of covariance (ANCOVA) comparing the HbA1c (%), defined as the percentage of hemoglobin proteins that are glycated (i.e., chemically linked to a sugar), at the Day 180 visit between the Enabled and Control arms. The statistical model included the randomization arm, center, and diabetes type as fixed classification effects, and HbA1c (%) at Day 0 as baseline covariates. Adjusted means with their 95% confidence intervals are provided.
Time frame: Day 180
Cohort 2: Percentage of Time Spent in Hypoglycemia (<54 mg/dL) From Day 90 to Day 120
The analysis of the primary outcome measure for Cohort 2 was an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm spent in hypoglycemia with a blood glucose level \<54 milligrams per decilitre (mg/dL) between the Day 90 and Day 120 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia \<54 mg/dL between the Day 0 and Day 30 visits) as baseline covariates. Adjusted means with their 95% confidence intervals are provided.
Time frame: From Day 90 to Day 120
Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Insertion
Time frame: At sensor insertion (Day 0)
Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Removal
Time frame: At sensor removal (up to Day 180)
Overall Number of Participants With at Least One Adverse Event
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not related to the investigational medical device. AEs were coded using the MedDRA dictionary version 20.1. All AEs were assessed by the investigator for relation to the device, seriousness (according to serious AE criteria), and severity (i.e., intensity of the event: mild, moderate, or severe). AEs of hypoglycemia were identified using a Standardized MedDRA Query (SMQ) for a list of Preferred Terms; all terms for hypoglycemia reported in the AE forms were considered symptomatic hypoglycemia. 'Severe hypoglycemia' included all serious and severe/life-threatening events of the SMQ for hypoglycemia. Serious diabetic ketoacidosis was identified in the AE forms using a set list of MedDRA terms. Adverse device effects (ADEs) included all AEs that were pre-specified in the electronic Case Report Form (eCRF).
Time frame: From Day 0 (Insertion) up to Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180
Percentage of Time Spent in the Euglycemic Range (70mg/dL-180mg/dL) From Day 90 to Day 120
The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in euglycemia with a blood glucose level ≥70 mg/dL to ≤180 mg/dL between the Day 90 and Day 120 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and centre (and diabetes type for Cohort 1) as fixed classification effects and the time in euglycemia at baseline (i.e. percentage of time spent in euglycemia between the Day 0 and Day 30 visits) as baseline covariates. Adjusted means with their 95% confidence intervals are provided.
Time frame: From Day 90 to Day 120
Percentage of Time Spent in Hyperglycemia (>250mg/dL) From Day 90 to Day 120
The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in hyperglycemia with a blood glucose level \>250 mg/dL between the Day 90 and Day 120 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects and the level of hyperglycemia at baseline (i.e. percentage of time spent in hyperglycemia \>250 mg/dL between the Day 0 and Day 30 visits) as baseline covariates. Adjusted means with their 95% confidence intervals are provided.
Time frame: From Day 90 to Day 120
Percentage of Time Spent in Hyperglycemia (>180mg/dL) From Day 90 to Day 120
The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in hyperglycemia with a blood glucose level \>180 mg/dL between the Day 90 and Day 120 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects and the level of hyperglycemia at baseline (i.e. percentage of time spent in hyperglycemia \>180 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.
Time frame: From Day 90 to Day 120
Percentage of Time Spent in Hypoglycemia (<70mg/dL) From Day 90 to Day 120
The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohort 1 spent in hypoglycemia with a blood glucose level \<70 mg/dL between the Day 90 and Day 120 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia \<70 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.
Time frame: From Day 90 to Day 120
Cohort 1: Percentage of Time Spent in Hypoglycemia (<54mg/dL) From Day 90 to Day 120
The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohort 1 spent in hypoglycemia with a blood glucose level \<54 mg/dL between the Day 90 and Day 120 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm, center, and diabetes type as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia \<54 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.
Time frame: From Day 90 to Day 120
Percentage of Time Spent in the Euglycemic Range (70mg/dL-180mg/dL) From Day 150 to Day 180
The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in euglycemia with a blood glucose level ≥70 mg/dL to ≤180 mg/dL between the Day 150 and Day 180 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in euglycemia between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.
Time frame: From Day 150 to Day 180
Percentage of Time Spent in Hyperglycemia (>250mg/dL) From Day 150 to Day 180
The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in hyperglycemia with a blood glucose level \>250 mg/dL between the Day 150 and Day 180 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hyperglycemia \>250 mg/dL between the Day 0 and Day 30 visits) as baseline covariates. Adjusted means with their 95% confidence intervals are provided.
Time frame: From Day 150 to Day 180
Percentage of Time Spent in Hyperglycemia (>180mg/dL) From Day 150 to Day 180
The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in hyperglycemia with a blood glucose level \>180 mg/dL between the Day 150 and Day 180 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hyperglycemia \>180 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.
Time frame: From Day 150 to Day 180
Percentage of Time Spent in Hypoglycemia (<70mg/dL) From Day 150 to Day 180
The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in hypoglycemia with a blood glucose level \<70 mg/dL between the Day 150 and Day 180 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia \<70 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.
Time frame: From Day 150 to Day 180
Percentage of Time Spent in Hypoglycemia (<54mg/dL) From Day 150 to Day 180
The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in hypoglycemia with a blood glucose level \<54 mg/dL between the Day 150 and Day 180 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia \<54 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.
Time frame: From Day 150 to Day 180
Cohort 2, Enabled Arm: Percentage of Time Spent in Hypoglycemia (<54 mg/dL) During the Day 90-120 Period Compared With the Day 150-180 Period for the Enabled Group
The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in the Enabled arm of Cohort 2 spent in hypoglycemia with a blood glucose level \<54 mg/dL over two different time periods (between the Days 90-120 and Days 150-180), based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the time period and center as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia \<54 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.
Time frame: Day 90 to Day 120; Day 150 to Day 180
Cohort 2, Control Arm: Percentage of Time Spent in Hypoglycemia (<54 mg/dL) During the Control Period (Days 90-120) Compared With the Enabled Period (Days 150-180) for Participants Who Switched to Use the CGM System
The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in the Cohort 2, Control arm spent in hypoglycemia with a blood glucose level \<54 mg/dL with a different intervention over each of the two time periods (the control period, using their usual glucose monitoring system: Days 90-120, and the enabled period, using the Eversense XL CGM system: Days 150-180), based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the time period and center as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia \<54 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.
Time frame: For Cohort 2, Control arm: Day 90 to Day 120; For Cohort 2, Switch from Control to Enabled arm: Day 150 to Day 180
Glucose Variability From Day 90 to Day 120, as Estimated With a Coefficient of Variation
Glucose variability was estimated with a unitless coefficient of variation, expressed as a percentage, which was computed using CGM data with the following formula: the sum of the ratios of standard deviation of daily glycemia to the mean of daily glycemia divided by the number of days with available data for the period of interest (Days 90 to 120). According to Monnier et al. Diabetes Care 2017, a coefficient of variation threshold set to 36% allows to distinguish between stable and unstable glycemia.
Time frame: From Day 90 to Day 120
Glucose Variability From Day 150 to Day 180, as Estimated by a Coefficient of Variation
Glucose variability was estimated with a unitless coefficient of variation, expressed as a percentage, which was computed using CGM data with the following formula: the sum of the ratios of standard deviation of daily glycemia to the mean of daily glycemia divided by the number of days with available data for the period of interest (Days 150 to 180). According to Monnier et al. Diabetes Care 2017, a coefficient of variation threshold set to 36% allows to distinguish between stable and unstable glycemia.
Time frame: From Day 150 to Day 180
HbA1c (%) Levels at Day 120
The results show an analysis of covariance (ANCOVA) comparing the HbA1c (%), defined as the percentage of hemoglobin proteins that are glycated (i.e., chemically linked to a sugar), at the Day 120 visit between the Enabled and Control arms for Cohorts 1 and 2. The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects, and HbA1c (%) at Day 0 as baseline covariates. Adjusted means with their 95% confidence interval are provided.
Time frame: Day 120
Cohort 2: HbA1c (%) Levels at Day 180
The analysis of this secondary outcome measure for Cohort 2 was an analysis of covariance (ANCOVA) comparing the HbA1c (%), defined as the percentage of hemoglobin proteins that are glycated (i.e., chemically linked to a sugar), at the Day 180 visit between the Enabled and Control arms. The statistical model included the randomization arm and center as fixed classification effects, and HbA1c (%) at Day 0 as baseline covariates. Adjusted means with their 95% confidence interval are provided.
Time frame: Day 180
Number of Participants With the First Sensor Operating at Day 150 and Day 180
This measure assesses sensor life by counting the number of participants with their first inserted CGM sensor still operating at 150 days and at 180 days post-insertion. The assessment was based on the lifespan of the first sensor: for example, if lifespan of the first sensor was ≥150 days and ≥180 days, then the participant was counted as having their first sensor operating at 150 days and 180 days, respectively. The lifespan of the first inserted CGM sensor for each participant, measured in days, was calculated as the date of the last glucose measurement by the sensor minus the date of the first glucose measurement by the sensor (+1 day).
Time frame: From Day 0 up to Day 150 and Day 180
Mean Lifespan of the First Sensor
The lifespan of the first inserted CGM sensor for each participant, measured in days, was calculated as the date of the last glucose measurement by the sensor minus the date of the first glucose measurement by the sensor (+1 day).
Time frame: From Day 0 up to Day 180
Median Number of Sensors Used by Each Participant During the Study
Time frame: From Day 0 to Day 180
Number of Participants With the First Transmitter Operating at Day 150 and Day 180
This measure assesses transmitter wear time by counting the number of participants with their first CGM transmitter still operating at 150 days and at 180 days after first use. The assessment was based on the lifespan of the first transmitter: for example, if lifespan of the first transmitter was ≥150 days and ≥180 days, then the participant was counted as having their first transmitter operating at 150 days and 180 days, respectively. The lifespan of the first CGM transmitter for each participant, measured in days, was calculated as the date of the last glucose measurement with the transmitter minus the date of the first glucose measurement with the transmitter (+1 day).
Time frame: From Day 0 up to Day 150 and Day 180
Mean Lifespan of the First Transmitter
The lifespan of the first CGM transmitter for each participant, measured in days, was calculated as the date of the last glucose measurement with the transmitter minus the date of the first glucose measurement with the transmitter (+1 day).
Time frame: From Day 0 up to Day 180
Median Number of Transmitters Used by Each Participant During the Study
Time frame: From Day 0 to Day 180
Number of Participants Who Accessed CGM Application Pages at Days 60, 120, and 180
This was a descriptive analysis of the number of participants in the Eversense XL CGM System Enabled groups who accessed the various CGM application (app) pages/functions at study Days 60, 120, and 180. The data were collected in the electronic Case Report Form.
Time frame: At Days 60, 120, and 180
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study
This outcome measure is a descriptive analysis of the number of participants who were issued various types of alarms and alerts by the Eversense XL CGM System through the mobile medical application. The alarms listed in the results table are a higher level classification for the different types of alerts that immediately follow it, until the next type of alarm is listed (for example, the 'Calibration' alarm included both 'Calibrate Now' and 'Calibration Past Due' alerts). Only participants in the Enabled groups of both cohorts actually received these alarms/alerts because the CGM remained in blinded mode for participants in the Control groups.
Time frame: From Day 0 up to Day 180
Diabetes Treatment Satisfaction Questionnaire - Original Status (DTSQs) Treatment Satisfaction Score at Baseline, Day 60, and Day 180
The DTSQs questionnaire contains eight items scored on a 7-point scale (i.e. each item is scored from 0 to 6). Six items measure Treatment Satisfaction, dealing with: satisfaction with current treatment; convenience of the treatment; flexibility; satisfaction with own understanding of participant's diabetes; how likely to recommend their present treatment; and how satisfied to continue with their present treatment. These are summed to produce a total Treatment Satisfaction score, with a minimum value of 0 and a maximum value of 36; a higher score indicates greater treatment satisfaction. In case of missing items, the overall score was calculated as the mean of the available items.
Time frame: Baseline (Day 0), Day 60, and Day 180
Change From Baseline in the DTSQs Treatment Satisfaction Score at Day 60 and Day 180
The DTSQs questionnaire contains eight items scored on a 7-point scale (i.e. each item is scored from 0 to 6). Six items measure Treatment Satisfaction (dealing with: satisfaction with current treatment; convenience of the treatment; flexibility; satisfaction with own understanding of participant's diabetes; how likely to recommend their present treatment; and how satisfied to continue with their present treatment). These are summed to produce a total Treatment Satisfaction score, with a minimum value of 0 and a maximum value of 36; a higher score indicates greater treatment satisfaction. For the change from baseline analysis, a positive value indicates an improvement in treatment satisfaction. In case of missing items, the overall score was calculated as the mean of the available items.
Time frame: Baseline (Day 0), Day 60, and Day 180
Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc) Treatment Satisfaction Score at Day 180
The DTSQc questionnaire contains eight items scored on a 7-point scale (i.e. each item is scored from -3 to +3). Six items measure Treatment Satisfaction (dealing with: satisfaction with current treatment; convenience of the treatment; flexibility; satisfaction with own understanding of participant's diabetes; how likely to recommend their present treatment; and how satisfied to continue with their present treatment). These are summed to produce a total Treatment Satisfaction score, with a minimum value of -18 and a maximum value of +18; a higher score indicates greater treatment satisfaction. In case of missing items, the overall score was calculated as the mean of the available items.
Time frame: Day 180
Audit of Diabetes-Dependent Quality of Life (ADDQoL) Score at Baseline and Day 180
The ADDQoL measures the impact of diabetes and its treatment on 19 specific aspects of life. The scale ranges from -3 to +1 for 19 life domains (impact rating) and from 0 to +3 in attributed importance (importance rating). A weighted score for each domain is calculated as a multiplier of impact rating and importance rating (ranging from -9 to +3). Finally, a mean weighted impact score (ADDQOL score) is calculated for the entire scale across all applicable domains; a higher score indicates greater quality of life.
Time frame: Baseline (Day 0) and Day 180
Change From Baseline in the Audit of Diabetes-Dependent Quality of Life (ADDQoL) Score at Day 180
The ADDQoL measures the impact of diabetes and its treatment on 19 specific aspects of life. The scale ranges from -3 to +1 for 19 life domains (impact rating) and from 0 to +3 in attributed importance (importance rating). A weighted score for each domain is calculated as a multiplier of impact rating and importance rating (ranging from -9 to +3). Finally, a mean weighted impact score (ADDQOL score) is calculated for the entire scale across all applicable domains; a higher score indicates greater quality of life. For the change from baseline analysis, a positive value indicates an improvement in quality of life.
Time frame: Baseline (Day 0) and Day 180
The Continuous Glucose Monitoring Satisfaction (CGM-SAT) Questionnaire Overall Score at Day 60 and Day 180
The CGM-SAT questionnaire comprises 44 item scales assessing experiences with CGM over the previous 6 months. The scale is designed to measure the impact of CGM on diabetes management and family relationships, plus on satisfaction with emotional, behavioral and cognitive effects of CGM use. The responses were rated on a 5-point scale from '1 = strongly agree' to '5 = strongly disagree'. The overall score corresponds to the mean of the 44 items of potential positive or negative effects of using the CGM device; a higher score reflects more favorable impact of, and satisfaction with CGM. In case of missing items, the overall score was calculated as the mean of the available items.
Time frame: Day 60 and Day 180
Change From Day 60 in the CGM-SAT Questionnaire Overall Score at Day 180
The CGM-SAT questionnaire comprises 44 item scales assessing experiences with CGM over the previous 6 months. The scale is designed to measure the impact of CGM on diabetes management and family relationships, plus on satisfaction with emotional, behavioral and cognitive effects of CGM use. The responses were rated on a 5-point scale from '1 = strongly agree' to '5 = strongly disagree'. The overall score corresponds to the mean of the 44 items of potential positive or negative effects of using the CGM device; a higher score (or positive change from baseline score) reflects more favorable impact of, and satisfaction with CGM. In case of missing items, the overall score was calculated as the mean of the available items.
Time frame: Day 60 and Day 180
Diabetes Distress Scale 2 (DDS2) Questionnaire Score at Baseline, Day 60, and Day 180
The DDS2 is a 2-item diabetes distress screening instrument asking respondents to rate on a 6-point scale (from 1 = 'Not a problem' to 6 = 'A very serious problem') the degree to which the following items caused distress: (1) feeling overwhelmed by the demands of living with diabetes, and (2) feeling that I am often failing with my diabetes regimen. The DDS2 score is the mean of the two items (ranging from 1 to 6). A lower DDS2 score (or a negative change from baseline score) indicates a lower level of distress. If one item was missing, then no score was computed.
Time frame: Baseline (Day 0), Day 60, and Day 180
Change From Baseline in the Diabetes Distress Scale 2 (DDS2) Questionnaire Score at Day 60 and Day 180
The DDS2 is a 2-item diabetes distress screening instrument asking respondents to rate on a 6-point scale (from 1 = 'Not a problem' to 6 = 'A very serious problem') the degree to which the following items caused distress: (1) feeling overwhelmed by the demands of living with diabetes, and (2) feeling that I am often failing with my diabetes regimen. The DDS2 score is the mean of the two items (ranging from 1 to 6). A lower DDS2 score (or a negative change from baseline score) indicates a lower level of distress. If one item was missing, then no score was computed.
Time frame: Baseline (Day 0), Day 60, and Day 180
Hypoglycemia Fear Survey, Part 2 (HFS2) Worry Subscale Score at Baseline, Day 60, and Day 180
HFS2 Worry items describe specific concerns that patients may have about their hypoglycemic episodes (e.g., being alone, episodes occurring during sleep, or having an accident). The 5-point Likert scale for each item ranges from 0 (never) to 4 (almost always), and the HFS2 Worry subscale score is the sum of all 18 items (ranging from 0 to 72). A lower HFS2 Worry subscale score (or a negative change from baseline score) indicates a lower level of fear of hypoglycemia. There was no plan to replace missing items: if one item was missing, the score was not computed.
Time frame: Baseline (Day 0), Day 60, and Day 180
Change From Baseline in the Hypoglycemia Fear Survey, Part 2 (HFS2) Worry Subscale Score at Day 60 and Day 180
HFS2 Worry items describe specific concerns that patients may have about their hypoglycemic episodes (e.g., being alone, episodes occurring during sleep, or having an accident). The 5-point Likert scale for each item ranges from 0 (never) to 4 (almost always), and the HFS2 Worry subscale score is the sum of all 18 items (ranging from 0 to 72). A lower HFS2 Worry subscale score (or a negative change from baseline score) indicates a lower level of fear of hypoglycemia. There was no plan to replace missing items: if one item was missing, the score was not computed.
Time frame: Baseline (Day 0), Day 60, and Day 180
Change From Baseline in the Partner Diabetes Distress Scale (Partner-DDS) Questionnaire Total and Subscale Scores at Day 60 and Day 180
The Partner-DDS is a 21-item self-report scale that highlights four critical dimensions of partner-related distress: "my partner's diabetes management", "how best to help", "diabetes and me", and "hypoglycemia". The scale ranges from 0 (not at all) to 4 (a great deal). The Partner-DDS yields a total diabetes distress score plus 4 subscale scores: Total Partner-DDS Score = Mean of the 21 items; My partner's diabetes management = Mean of item 3, 4, 10, 12, 14, 15 and 20; How best to help = Mean of item 2, 6, 7, 11 and 13; Diabetes and me = Mean of items 5, 8, 9, 16 and 21; Hypoglycemia = Mean of items 1, 17, 18 and 19. A lower Partner-DDS score (or a negative change from baseline score) indicates a lower level of distress.
Time frame: Baseline (Day 0), Day 60, and Day 180
| Milestone | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Started | 97 | 52 | 62 | 28 |
| Completed | 90 | 43 | 57 | 25 |
| Not completed | 7 | 9 | 5 | 3 |
| Withdrew: Withdrawal by subject | 3 | 6 | 2 | 2 |
| Withdrew: Other | 4 | 3 | 3 | 1 |
The analysis of the primary outcome measure for Cohort 1 was an analysis of covariance (ANCOVA) comparing the HbA1c (%), defined as the percentage of hemoglobin proteins that are glycated (i.e., chemically linked to a sugar), at the Day 180 visit between the Enabled and Control arms. The statistical model included the randomization arm, center, and diabetes type as fixed classification effects, and HbA1c (%) at Day 0 as baseline covariates. Adjusted means with their 95% confidence intervals are provided.
| HbA1c (%) | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|
| Cohort 1: HbA1c (%) Levels at Day 180 | 8.6 (8.4 to 8.9) | 8.8 (8.5 to 9.0) |
The analysis of the primary outcome measure for Cohort 2 was an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm spent in hypoglycemia with a blood glucose level \<54 milligrams per decilitre (mg/dL) between the Day 90 and Day 120 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia \<54 mg/dL between the Day 0 and Day 30 visits) as baseline covariates. Adjusted means with their 95% confidence intervals are provided.
| Percentage of time | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|
| Cohort 2: Percentage of Time Spent in Hypoglycemia (<54 mg/dL) From Day 90 to Day 120 | 4.0 (3.0 to 5.1) | 5.7 (4.2 to 7.1) |
| Participants | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| At Least One Infection, Local or Systemic | 1 | 1 | 1 | 0 |
| At Least One Bleeding | 0 | 0 | 0 | 1 |
| At Least One Edema or Swelling | 0 | 1 | 0 | 0 |
| At Least One Scar Formation and/or Keloid | 0 | 0 | 0 | 0 |
| At Least One Skin Irritation and/or Redness | 4 | 1 | 1 | 0 |
| At Least One Nerve Damage Causing Tingling, Numbness, Pain, or Weakness | 1 | 0 | 0 | 0 |
| At Least One Itching and/or Pruritus | 2 | 0 | 2 | 1 |
| At Least One Discoloration of Skin | 0 | 1 | 0 | 0 |
| At Least One Hematoma Formation | 0 | 2 | 3 | 0 |
| At Least One Pain and/or Burning Sensation | 1 | 1 | 0 | 0 |
| At Least One Device Migration | 0 | 0 | 0 | 0 |
| Participants | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| At Least One Infection, Local or Systemic | 0 | 0 | 0 | 0 |
| At Least One Bleeding | 0 | 0 | 0 | 0 |
| At Least One Edema or Swelling | 0 | 0 | 0 | 0 |
| At Least One Scar Formation and/or Keloid | 0 | 0 | 0 | 0 |
| At Least One Skin Irritation and/or Redness | 0 | 0 | 0 | 0 |
| At Least One Nerve Damage Causing Tingling, Numbness, Pain, or Weakness | 0 | 0 | 0 | 0 |
| At Least One Itching and/or Pruritus | 0 | 0 | 0 | 0 |
| At Least One Discoloration of Skin | 0 | 0 | 0 | 0 |
| At Least One Hematoma Formation | 0 | 1 | 0 | 0 |
| At Least One Pain and/or Burning Sensation | 1 | 1 | 1 | 0 |
| At Least One Device Migration | 0 | 0 | 0 | 0 |
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not related to the investigational medical device. AEs were coded using the MedDRA dictionary version 20.1. All AEs were assessed by the investigator for relation to the device, seriousness (according to serious AE criteria), and severity (i.e., intensity of the event: mild, moderate, or severe). AEs of hypoglycemia were identified using a Standardized MedDRA Query (SMQ) for a list of Preferred Terms; all terms for hypoglycemia reported in the AE forms were considered symptomatic hypoglycemia. 'Severe hypoglycemia' included all serious and severe/life-threatening events of the SMQ for hypoglycemia. Serious diabetic ketoacidosis was identified in the AE forms using a set list of MedDRA terms. Adverse device effects (ADEs) included all AEs that were pre-specified in the electronic Case Report Form (eCRF).
| Participants | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control (Day 0 to 120) - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System |
|---|---|---|---|---|---|
| At Least One AE | 46 | 19 | 25 | 9 | 2 |
| At Least One Serious AE | 7 | 5 | 2 | 0 | 0 |
| At Least One Fatal AE | 0 | 0 | 0 | 0 | 0 |
| At Least One Mild AE (Maximum Severity) | 27 | 14 | 14 | 8 | 1 |
| At Least One Moderate AE (Maximum Severity) | 28 | 8 | 14 | 3 | 1 |
| At Least One Severe AE (Maximum Severity) | 6 | 5 | 2 | 0 | 0 |
| At Least One AE Leading to Discontinuation of Device | 2 | 4 | 0 | 1 | 0 |
| At Least One AE Related (Possible or Probable) to Device | 15 | 7 | 11 | 3 | 0 |
| At Least One AE of Symptomatic Hypoglycemia | 2 | 2 | 4 | 2 | 1 |
| At Least One AE of Severe Hypoglycemia | 0 | 1 | 0 | 0 | 0 |
| At Least One AE of Serious Diabetic Ketoacidosis | 1 | 0 | 0 | 0 | 0 |
| At Least One Adverse Device Effect (ADE), Collected in the eCRF | 59 | 30 | 40 | 13 | 5 |
| At Least One ADE, Reported to the Hotline | 39 | 17 | 28 | 7 | 5 |
The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in euglycemia with a blood glucose level ≥70 mg/dL to ≤180 mg/dL between the Day 90 and Day 120 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and centre (and diabetes type for Cohort 1) as fixed classification effects and the time in euglycemia at baseline (i.e. percentage of time spent in euglycemia between the Day 0 and Day 30 visits) as baseline covariates. Adjusted means with their 95% confidence intervals are provided.
| Percentage of time | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Percentage of Time Spent in the Euglycemic Range (70mg/dL-180mg/dL) From Day 90 to Day 120 | 47.4 (42.0 to 52.9) | 42.1 (35.8 to 48.4) | 59.8 (57.2 to 62.3) | 55.0 (51.5 to 58.6) |
The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in hyperglycemia with a blood glucose level \>250 mg/dL between the Day 90 and Day 120 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects and the level of hyperglycemia at baseline (i.e. percentage of time spent in hyperglycemia \>250 mg/dL between the Day 0 and Day 30 visits) as baseline covariates. Adjusted means with their 95% confidence intervals are provided.
| Percentage of time | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Percentage of Time Spent in Hyperglycemia (>250mg/dL) From Day 90 to Day 120 | 18.5 (14.1 to 22.9) | 24.0 (19.0 to 29.1) | 8.5 (6.4 to 10.6) | 9.5 (6.7 to 12.4) |
The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in hyperglycemia with a blood glucose level \>180 mg/dL between the Day 90 and Day 120 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects and the level of hyperglycemia at baseline (i.e. percentage of time spent in hyperglycemia \>180 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.
| Percentage of time | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Percentage of Time Spent in Hyperglycemia (>180mg/dL) From Day 90 to Day 120 | 50.0 (44.3 to 55.8) | 55.2 (48.6 to 61.8) | 30.7 (28.0 to 33.5) | 34.0 (30.2 to 37.9) |
The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohort 1 spent in hypoglycemia with a blood glucose level \<70 mg/dL between the Day 90 and Day 120 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia \<70 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.
| Percentage of time | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Percentage of Time Spent in Hypoglycemia (<70mg/dL) From Day 90 to Day 120 | 2.6 (1.6 to 3.5) | 2.8 (1.7 to 3.9) | 9.5 (7.9 to 11.1) | 11.3 (9.1 to 13.5) |
The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohort 1 spent in hypoglycemia with a blood glucose level \<54 mg/dL between the Day 90 and Day 120 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm, center, and diabetes type as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia \<54 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.
| Percentage of time | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|
| Cohort 1: Percentage of Time Spent in Hypoglycemia (<54mg/dL) From Day 90 to Day 120 | 1.1 (0.5 to 1.6) | 1.2 (0.5 to 1.8) |
The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in euglycemia with a blood glucose level ≥70 mg/dL to ≤180 mg/dL between the Day 150 and Day 180 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in euglycemia between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.
| Percentage of time | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Percentage of Time Spent in the Euglycemic Range (70mg/dL-180mg/dL) From Day 150 to Day 180 | 47.0 (41.3 to 52.8) | 48.0 (41.4 to 54.6) | 60.7 (57.8 to 63.6) | 61.1 (57.1 to 65.1) |
The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in hyperglycemia with a blood glucose level \>250 mg/dL between the Day 150 and Day 180 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hyperglycemia \>250 mg/dL between the Day 0 and Day 30 visits) as baseline covariates. Adjusted means with their 95% confidence intervals are provided.
| Percentage of time | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Percentage of Time Spent in Hyperglycemia (>250mg/dL) From Day 150 to Day 180 | 18.5 (14.6 to 22.5) | 19.4 (14.9 to 23.9) | 8.7 (6.9 to 10.4) | 6.3 (3.9 to 8.8) |
The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in hyperglycemia with a blood glucose level \>180 mg/dL between the Day 150 and Day 180 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hyperglycemia \>180 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.
| Percentage of time | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Percentage of Time Spent in Hyperglycemia (>180mg/dL) From Day 150 to Day 180 | 50.8 (44.7 to 56.8) | 49.5 (42.5 to 56.5) | 30.9 (27.6 to 34.2) | 27.8 (23.3 to 32.3) |
The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in hypoglycemia with a blood glucose level \<70 mg/dL between the Day 150 and Day 180 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia \<70 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.
| Percentage of time | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Percentage of Time Spent in Hypoglycemia (<70mg/dL) From Day 150 to Day 180 | 2.1 (0.9 to 3.2) | 2.4 (1.1 to 3.8) | 8.4 (6.3 to 10.5) | 11.7 (8.8 to 14.5) |
The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in hypoglycemia with a blood glucose level \<54 mg/dL between the Day 150 and Day 180 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia \<54 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.
| Percentage of time | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Percentage of Time Spent in Hypoglycemia (<54mg/dL) From Day 150 to Day 180 | 1.1 (0.4 to 1.7) | 1.0 (0.3 to 1.8) | 3.4 (2.1 to 4.8) | 6.0 (4.1 to 7.9) |
The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in the Enabled arm of Cohort 2 spent in hypoglycemia with a blood glucose level \<54 mg/dL over two different time periods (between the Days 90-120 and Days 150-180), based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the time period and center as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia \<54 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.
| Percentage of time | Cohort 2, Enabled (Day 90 to 120) - Eversense XL CGM System | Cohort 2, Enabled (Day 150 to 180) - Eversense XL CGM System |
|---|---|---|
| Cohort 2, Enabled Arm: Percentage of Time Spent in Hypoglycemia (<54 mg/dL) During the Day 90-120 Period Compared With the Day 150-180 Period for the Enabled Group | 4.232 (3.242 to 5.222) | 3.430 (2.469 to 4.391) |
The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in the Cohort 2, Control arm spent in hypoglycemia with a blood glucose level \<54 mg/dL with a different intervention over each of the two time periods (the control period, using their usual glucose monitoring system: Days 90-120, and the enabled period, using the Eversense XL CGM system: Days 150-180), based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the time period and center as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia \<54 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.
| Percentage of time | Cohort 2, Control (Day 90 to 120) - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Switch From Control to Enabled (Day 150 to 180) - Eversense XL CGM System |
|---|---|---|
| Cohort 2, Control Arm: Percentage of Time Spent in Hypoglycemia (<54 mg/dL) During the Control Period (Days 90-120) Compared With the Enabled Period (Days 150-180) for Participants Who Switched to Use the CGM System | 5.792 (3.672 to 7.913) | 6.263 (2.737 to 9.788) |
Glucose variability was estimated with a unitless coefficient of variation, expressed as a percentage, which was computed using CGM data with the following formula: the sum of the ratios of standard deviation of daily glycemia to the mean of daily glycemia divided by the number of days with available data for the period of interest (Days 90 to 120). According to Monnier et al. Diabetes Care 2017, a coefficient of variation threshold set to 36% allows to distinguish between stable and unstable glycemia.
| Coefficient of variation (%) | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Glucose Variability From Day 90 to Day 120, as Estimated With a Coefficient of Variation | 29.3 (27.5 to 31.1) | 28.0 (26.0 to 30.0) | 35.8 (34.3 to 37.3) | 36.3 (34.3 to 38.3) |
Glucose variability was estimated with a unitless coefficient of variation, expressed as a percentage, which was computed using CGM data with the following formula: the sum of the ratios of standard deviation of daily glycemia to the mean of daily glycemia divided by the number of days with available data for the period of interest (Days 150 to 180). According to Monnier et al. Diabetes Care 2017, a coefficient of variation threshold set to 36% allows to distinguish between stable and unstable glycemia.
| Coefficient of variation (%) | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Glucose Variability From Day 150 to Day 180, as Estimated by a Coefficient of Variation | 26.0 (23.9 to 28.1) | 25.0 (22.6 to 27.5) | 34.4 (32.8 to 36.0) | 35.1 (32.8 to 37.3) |
The results show an analysis of covariance (ANCOVA) comparing the HbA1c (%), defined as the percentage of hemoglobin proteins that are glycated (i.e., chemically linked to a sugar), at the Day 120 visit between the Enabled and Control arms for Cohorts 1 and 2. The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects, and HbA1c (%) at Day 0 as baseline covariates. Adjusted means with their 95% confidence interval are provided.
| HbA1c (%) | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| HbA1c (%) Levels at Day 120 | 8.6 (8.4 to 8.9) | 8.7 (8.4 to 9.0) | 7.2 (7.0 to 7.3) | 7.3 (7.0 to 7.5) |
The analysis of this secondary outcome measure for Cohort 2 was an analysis of covariance (ANCOVA) comparing the HbA1c (%), defined as the percentage of hemoglobin proteins that are glycated (i.e., chemically linked to a sugar), at the Day 180 visit between the Enabled and Control arms. The statistical model included the randomization arm and center as fixed classification effects, and HbA1c (%) at Day 0 as baseline covariates. Adjusted means with their 95% confidence interval are provided.
| HbA1c (%) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|
| Cohort 2: HbA1c (%) Levels at Day 180 | 7.2 (7.0 to 7.4) | 7.2 (6.9 to 7.4) |
This measure assesses sensor life by counting the number of participants with their first inserted CGM sensor still operating at 150 days and at 180 days post-insertion. The assessment was based on the lifespan of the first sensor: for example, if lifespan of the first sensor was ≥150 days and ≥180 days, then the participant was counted as having their first sensor operating at 150 days and 180 days, respectively. The lifespan of the first inserted CGM sensor for each participant, measured in days, was calculated as the date of the last glucose measurement by the sensor minus the date of the first glucose measurement by the sensor (+1 day).
| Participants | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Day 150 | 73 | 27 | 40 | 19 |
| Day 180 | 38 | 10 | 27 | 12 |
The lifespan of the first inserted CGM sensor for each participant, measured in days, was calculated as the date of the last glucose measurement by the sensor minus the date of the first glucose measurement by the sensor (+1 day).
| Days | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Mean Lifespan of the First Sensor | 159.2 ± 33.0 | 139.8 ± 46.3 | 147.3 ± 47.8 | 156.9 ± 33.2 |
| Sensors per participant | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Median Number of Sensors Used by Each Participant During the Study | 1.0 (1.0 to 2.0) | 1.0 (1.0 to 2.0) | 1.0 (1.0 to 2.0) | 1.0 (1.0 to 2.0) |
This measure assesses transmitter wear time by counting the number of participants with their first CGM transmitter still operating at 150 days and at 180 days after first use. The assessment was based on the lifespan of the first transmitter: for example, if lifespan of the first transmitter was ≥150 days and ≥180 days, then the participant was counted as having their first transmitter operating at 150 days and 180 days, respectively. The lifespan of the first CGM transmitter for each participant, measured in days, was calculated as the date of the last glucose measurement with the transmitter minus the date of the first glucose measurement with the transmitter (+1 day).
| Participants | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Day 150 | 1 | 23 | 0 | 3 |
| Day 180 | 1 | 13 | 0 | 3 |
The lifespan of the first CGM transmitter for each participant, measured in days, was calculated as the date of the last glucose measurement with the transmitter minus the date of the first glucose measurement with the transmitter (+1 day).
| Days | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Mean Lifespan of the First Transmitter | 34.6 ± 19.2 | 140.6 ± 46.5 | 33.8 ± 12.4 | 114.6 ± 39.2 |
| Transmitters per participant | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Median Number of Transmitters Used by Each Participant During the Study | 2.0 (1.0 to 4.0) | 1.0 (1.0 to 2.0) | 2.0 (1.0 to 3.0) | 2.0 (1.0 to 4.0) |
This was a descriptive analysis of the number of participants in the Eversense XL CGM System Enabled groups who accessed the various CGM application (app) pages/functions at study Days 60, 120, and 180. The data were collected in the electronic Case Report Form.
| Participants | Cohort 1, Enabled - Eversense XL CGM System | Cohort 2, Enabled - Eversense XL CGM System |
|---|---|---|
| Day 60 - Participant uses the 'Report' function | 67 | 43 |
| Day 60 - Participant uses the 'Historic of Alerts' function | 75 | 44 |
| Day 60 - Participant uses the 'Log Event' function | 61 | 38 |
| Day 60 - Participant uses phone to look at their glucose levels | 95 | 61 |
| Day 120 - Participant uses the 'Report' function | 66 | 50 |
| Day 120 - Participant uses the 'Historic of Alerts' function | 74 | 40 |
| Day 120 - Participant uses the 'Log Event' function | 63 | 28 |
| Day 120 - Participant uses phone to look at their glucose levels | 89 | 58 |
| Day 180 - Participant uses the 'Report' function | 58 | 49 |
| Day 180 - Participant uses the 'Historic of Alerts' function | 61 | 46 |
| Day 180 - Participant uses the 'Log Event' function | 54 | 35 |
| Day 180 - Participant uses phone to look at their glucose levels | 81 | 55 |
This outcome measure is a descriptive analysis of the number of participants who were issued various types of alarms and alerts by the Eversense XL CGM System through the mobile medical application. The alarms listed in the results table are a higher level classification for the different types of alerts that immediately follow it, until the next type of alarm is listed (for example, the 'Calibration' alarm included both 'Calibrate Now' and 'Calibration Past Due' alerts). Only participants in the Enabled groups of both cohorts actually received these alarms/alerts because the CGM remained in blinded mode for participants in the Control groups.
| Participants | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| At Least 1 Alarm of Any Type | 97 | 52 | 62 | 28 |
| At Least 1 'Calibration' Alarm | 97 | 52 | 62 | 28 |
| At Least 1 'Calibrate Now' Alert | 97 | 52 | 62 | 28 |
| At Least 1 'Calibration Past Due' Alert | 95 | 50 | 61 | 26 |
| At Least 1 'Sensor Glucose' Alarm | 95 | 2 | 61 | 22 |
| At Least 1 'High Glucose' Alert | 95 | 2 | 61 | 22 |
| At Least 1 'Low Glucose' Alert | 94 | 2 | 61 | 22 |
| At Least 1 'Out of Range High Glucose' Alert | 86 | 1 | 47 | 8 |
| At Least 1 'Out of Range Low Glucose' Alert | 84 | 2 | 61 | 22 |
| At Least 1 'Predicted High Glucose' Alert | 44 | 1 | 39 | 8 |
| At Least 1 'Predicted Low Glucose' Alert | 44 | 1 | 38 | 8 |
| At Least 1 'Rate Falling' Alert | 31 | 1 | 27 | 6 |
| At Least 1 'Rate Rising' Alert | 31 | 1 | 27 | 6 |
| At Least 1 'Sensor Glucose and Calibration' Alarm | 31 | 19 | 18 | 10 |
| At Least 1 'Sensor Check' Alert | 31 | 19 | 18 | 10 |
| At Least 1 'Sensor Related' Alarm | 97 | 52 | 62 | 28 |
| At Least 1 'High Ambient Light Alert' Alert | 84 | 40 | 47 | 19 |
| At Least 1 'High Sensor Temperature' Alert | 1 | 1 | 3 | 0 |
| At Least 1 'Low Sensor Temperature' Alert | 7 | 4 | 4 | 4 |
| At Least 1 'New Sensor Detected' Alert | 95 | 51 | 62 | 28 |
| At Least 1 'Sensor Replacement' Alert | 93 | 46 | 58 | 27 |
| At Least 1 'System Related' Alarm, 'Displayed on the Status Bar of the App' Alert | 97 | 52 | 62 | 28 |
| At Least 1 'Transmitter Related' Alarm | 97 | 52 | 62 | 28 |
| At Least 1 'Battery Empty' Alert | 82 | 44 | 57 | 21 |
| At Least 1 'Charge Transmitter' Alert | 94 | 49 | 59 | 28 |
| At Least 1 'High Transmitter Temperature' Alert | 21 | 11 | 16 | 4 |
| At Least 1 'Transmitter Disconnect' Alert | 97 | 52 | 62 | 28 |
| At Least 1 'Transmitter Error' Alert | 9 | 2 | 6 | 3 |
The DTSQs questionnaire contains eight items scored on a 7-point scale (i.e. each item is scored from 0 to 6). Six items measure Treatment Satisfaction, dealing with: satisfaction with current treatment; convenience of the treatment; flexibility; satisfaction with own understanding of participant's diabetes; how likely to recommend their present treatment; and how satisfied to continue with their present treatment. These are summed to produce a total Treatment Satisfaction score, with a minimum value of 0 and a maximum value of 36; a higher score indicates greater treatment satisfaction. In case of missing items, the overall score was calculated as the mean of the available items.
| Score on a scale | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Baseline | 27.0 ± 6.0 | 24.4 ± 6.3 | 26.4 ± 5.4 | 26.8 ± 5.7 |
| Day 60 | 28.3 ± 5.8 | 24.3 ± 5.9 | 27.9 ± 4.9 | 24.4 ± 6.1 |
| Day 180 | 26.8 ± 6.4 | 24.5 ± 7.1 | 27.6 ± 4.2 | 26.2 ± 6.1 |
The DTSQs questionnaire contains eight items scored on a 7-point scale (i.e. each item is scored from 0 to 6). Six items measure Treatment Satisfaction (dealing with: satisfaction with current treatment; convenience of the treatment; flexibility; satisfaction with own understanding of participant's diabetes; how likely to recommend their present treatment; and how satisfied to continue with their present treatment). These are summed to produce a total Treatment Satisfaction score, with a minimum value of 0 and a maximum value of 36; a higher score indicates greater treatment satisfaction. For the change from baseline analysis, a positive value indicates an improvement in treatment satisfaction. In case of missing items, the overall score was calculated as the mean of the available items.
| Score on a scale | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Change from Baseline at Day 60 | 1.3 ± 5.1 | 0.2 ± 6.3 | 1.7 ± 5.5 | -1.8 ± 4.1 |
| Change from Baseline at Day 180 | -0.1 ± 6.4 | -0.1 ± 6.6 | 1.3 ± 4.4 | -0.1 ± 4.8 |
The DTSQc questionnaire contains eight items scored on a 7-point scale (i.e. each item is scored from -3 to +3). Six items measure Treatment Satisfaction (dealing with: satisfaction with current treatment; convenience of the treatment; flexibility; satisfaction with own understanding of participant's diabetes; how likely to recommend their present treatment; and how satisfied to continue with their present treatment). These are summed to produce a total Treatment Satisfaction score, with a minimum value of -18 and a maximum value of +18; a higher score indicates greater treatment satisfaction. In case of missing items, the overall score was calculated as the mean of the available items.
| Score on a scale | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc) Treatment Satisfaction Score at Day 180 | 8.6 ± 7.8 | 7.1 ± 7.0 | 8.6 ± 6.6 | 5.3 ± 8.7 |
The ADDQoL measures the impact of diabetes and its treatment on 19 specific aspects of life. The scale ranges from -3 to +1 for 19 life domains (impact rating) and from 0 to +3 in attributed importance (importance rating). A weighted score for each domain is calculated as a multiplier of impact rating and importance rating (ranging from -9 to +3). Finally, a mean weighted impact score (ADDQOL score) is calculated for the entire scale across all applicable domains; a higher score indicates greater quality of life.
| Score on a scale | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Baseline | -2.9 ± 1.9 | -3.0 ± 1.6 | -2.7 ± 1.9 | -1.9 ± 1.4 |
| Day 180 | -2.7 ± 1.9 | -3.2 ± 2.1 | -2.5 ± 1.7 | -1.4 ± 1.2 |
The ADDQoL measures the impact of diabetes and its treatment on 19 specific aspects of life. The scale ranges from -3 to +1 for 19 life domains (impact rating) and from 0 to +3 in attributed importance (importance rating). A weighted score for each domain is calculated as a multiplier of impact rating and importance rating (ranging from -9 to +3). Finally, a mean weighted impact score (ADDQOL score) is calculated for the entire scale across all applicable domains; a higher score indicates greater quality of life. For the change from baseline analysis, a positive value indicates an improvement in quality of life.
| Score on a scale | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Change From Baseline in the Audit of Diabetes-Dependent Quality of Life (ADDQoL) Score at Day 180 | 0.1 ± 1.4 | 0.0 ± 1.0 | 0.1 ± 1.1 | 0.4 ± 1.2 |
The CGM-SAT questionnaire comprises 44 item scales assessing experiences with CGM over the previous 6 months. The scale is designed to measure the impact of CGM on diabetes management and family relationships, plus on satisfaction with emotional, behavioral and cognitive effects of CGM use. The responses were rated on a 5-point scale from '1 = strongly agree' to '5 = strongly disagree'. The overall score corresponds to the mean of the 44 items of potential positive or negative effects of using the CGM device; a higher score reflects more favorable impact of, and satisfaction with CGM. In case of missing items, the overall score was calculated as the mean of the available items.
| Score on a scale | Cohort 1, Enabled - Eversense XL CGM System | Cohort 2, Enabled - Eversense XL CGM System |
|---|---|---|
| Day 60 | 2.9 ± 0.3 | 3.0 ± 0.3 |
| Day 180 | 2.8 ± 0.3 | 2.8 ± 0.3 |
The CGM-SAT questionnaire comprises 44 item scales assessing experiences with CGM over the previous 6 months. The scale is designed to measure the impact of CGM on diabetes management and family relationships, plus on satisfaction with emotional, behavioral and cognitive effects of CGM use. The responses were rated on a 5-point scale from '1 = strongly agree' to '5 = strongly disagree'. The overall score corresponds to the mean of the 44 items of potential positive or negative effects of using the CGM device; a higher score (or positive change from baseline score) reflects more favorable impact of, and satisfaction with CGM. In case of missing items, the overall score was calculated as the mean of the available items.
| Score on a scale | Cohort 1, Enabled - Eversense XL CGM System | Cohort 2, Enabled - Eversense XL CGM System |
|---|---|---|
| Change From Day 60 in the CGM-SAT Questionnaire Overall Score at Day 180 | -0.1 ± 0.3 | -0.1 ± 0.2 |
The DDS2 is a 2-item diabetes distress screening instrument asking respondents to rate on a 6-point scale (from 1 = 'Not a problem' to 6 = 'A very serious problem') the degree to which the following items caused distress: (1) feeling overwhelmed by the demands of living with diabetes, and (2) feeling that I am often failing with my diabetes regimen. The DDS2 score is the mean of the two items (ranging from 1 to 6). A lower DDS2 score (or a negative change from baseline score) indicates a lower level of distress. If one item was missing, then no score was computed.
| Score on a scale | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Baseline | 2.4 ± 1.1 | 3.1 ± 1.6 | 2.8 ± 1.2 | 2.3 ± 1.0 |
| Day 60 | 2.1 ± 1.0 | 3.0 ± 1.2 | 2.6 ± 1.5 | 3.0 ± 2.0 |
| Day 180 | 2.1 ± 1.2 | 2.6 ± 1.1 | 2.4 ± 1.3 | 2.0 ± 1.1 |
The DDS2 is a 2-item diabetes distress screening instrument asking respondents to rate on a 6-point scale (from 1 = 'Not a problem' to 6 = 'A very serious problem') the degree to which the following items caused distress: (1) feeling overwhelmed by the demands of living with diabetes, and (2) feeling that I am often failing with my diabetes regimen. The DDS2 score is the mean of the two items (ranging from 1 to 6). A lower DDS2 score (or a negative change from baseline score) indicates a lower level of distress. If one item was missing, then no score was computed.
| Score on a scale | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Change from Baseline at Day 60 | -0.2 ± 0.8 | 0.0 ± 1.2 | -0.3 ± 2.1 | 0.6 ± 1.4 |
| Change from Baseline at Day 180 | -0.2 ± 0.9 | -0.6 ± 1.5 | -0.5 ± 1.9 | 0.0 ± 0.8 |
HFS2 Worry items describe specific concerns that patients may have about their hypoglycemic episodes (e.g., being alone, episodes occurring during sleep, or having an accident). The 5-point Likert scale for each item ranges from 0 (never) to 4 (almost always), and the HFS2 Worry subscale score is the sum of all 18 items (ranging from 0 to 72). A lower HFS2 Worry subscale score (or a negative change from baseline score) indicates a lower level of fear of hypoglycemia. There was no plan to replace missing items: if one item was missing, the score was not computed.
| Score on a scale | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Baseline | 21.4 ± 12.0 | 21.6 ± 9.4 | 26.6 ± 14.4 | 19.0 ± 7.9 |
| Day 60 | 17.4 ± 10.7 | 21.3 ± 9.7 | 27.1 ± 16.2 | 18.8 ± 13.8 |
| Day 180 | 15.4 ± 11.3 | 24.4 ± 6.2 | 28.9 ± 17.0 | 14.8 ± 11.4 |
HFS2 Worry items describe specific concerns that patients may have about their hypoglycemic episodes (e.g., being alone, episodes occurring during sleep, or having an accident). The 5-point Likert scale for each item ranges from 0 (never) to 4 (almost always), and the HFS2 Worry subscale score is the sum of all 18 items (ranging from 0 to 72). A lower HFS2 Worry subscale score (or a negative change from baseline score) indicates a lower level of fear of hypoglycemia. There was no plan to replace missing items: if one item was missing, the score was not computed.
| Score on a scale | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| Change from Baseline at Day 60 | -4.0 ± 8.7 | -0.3 ± 6.8 | -1.4 ± 7.2 | -1.4 ± 6.2 |
| Change from Baseline at Day 180 | -5.2 ± 9.8 | 1.4 ± 12.5 | 0.9 ± 10.1 | -3.0 ± 4.8 |
The Partner-DDS is a 21-item self-report scale that highlights four critical dimensions of partner-related distress: "my partner's diabetes management", "how best to help", "diabetes and me", and "hypoglycemia". The scale ranges from 0 (not at all) to 4 (a great deal). The Partner-DDS yields a total diabetes distress score plus 4 subscale scores: Total Partner-DDS Score = Mean of the 21 items; My partner's diabetes management = Mean of item 3, 4, 10, 12, 14, 15 and 20; How best to help = Mean of item 2, 6, 7, 11 and 13; Diabetes and me = Mean of items 5, 8, 9, 16 and 21; Hypoglycemia = Mean of items 1, 17, 18 and 19. A lower Partner-DDS score (or a negative change from baseline score) indicates a lower level of distress.
| Score on a scale | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) |
|---|---|---|---|---|
| My Partner's Diabetes Management - Change from Baseline (BL) at Day 60 | 0.0 ± 0.4 | 0.1 ± 0.7 | 0.1 ± 0.3 | -0.4 ± 0.4 |
| My Partner's Diabetes Management - Change from BL at Day 180 | -1.1 ± 1.5 | 0.6 ± NA | -0.3 ± 0.0 | -0.7 ± 0.2 |
| How Best to Help - Change from BL at Day 60 | -1.7 ± 1.0 | 0.9 ± 0.1 | 0.1 ± 0.4 | -0.2 ± 0.0 |
| How Best to Help - Change from BL at Day 180 | -0.5 ± 0.4 | 1.4 ± NA | -0.8 ± 0.3 | -0.3 ± 0.1 |
| Diabetes and Me - Change from BL at Day 60 | -0.3 ± 0.7 | 0.2 ± 0.3 | 0.1 ± 0.4 | -0.3 ± 0.4 |
| Diabetes and Me - Change from BL at Day 180 | 0.3 ± 0.4 | 0.4 ± NA | -0.9 ± 0.1 | -0.5 ± 0.4 |
| Hypoglycemia - Change from BL at Day 60 | -0.3 ± 0.0 | -0.1 ± 0.5 | 0.1 ± 0.2 | 0.5 ± 1.1 |
| Hypoglycemia - Change from BL at Day 180 | 0.6 ± 1.2 | 0.0 ± NA | 0.4 ± 0.9 | -0.3 ± 0.4 |
| PDDS Score - Change from BL at Day 60 | -0.5 ± 0.3 | 0.3 ± 0.1 | 0.1 ± 0.3 | -0.2 ± 0.2 |
| PDDS Score - Change from BL at Day 180 | -0.3 ± 0.9 | 0.6 ± NA | -0.4 ± 0.2 | -0.5 ± 0.1 |
Collected over From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1, Enabled - Eversense XL CGM System | 0/97 (0%) | 7/97 (7.2%) | 2/97 (2.1%) |
| Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | 0/52 (0%) | 5/52 (9.6%) | 1/52 (1.9%) |
| Cohort 2, Enabled - Eversense XL CGM System | 0/62 (0%) | 2/62 (3.2%) | 4/62 (6.5%) |
| Cohort 2, Control (Day 0 to 120) - Usual Glucose Monitoring System (SMBG or FGM) | 0/28 (0%) | 0/28 (0%) | 1/28 (3.6%) |
| Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System | 0/28 (0%) | 0/28 (0%) | 1/28 (3.6%) |
| Event | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control (Day 0 to 120) - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System |
|---|---|---|---|---|---|
| Diabetes mellitus inadequate controlMetabolism and nutrition disorders | 2/97 | 0/52 | 0/62 | 0/28 | 0/28 |
| Diabetic ketosisMetabolism and nutrition disorders | 0/97 | 1/52 | 0/62 | 0/28 | 0/28 |
| Hypoglycaemic comaNervous system disorders | 0/97 | 1/52 | 0/62 | 0/28 | 0/28 |
| Burnout syndromePsychiatric disorders | 0/97 | 1/52 | 0/62 | 0/28 | 0/28 |
| Acute kidney injuryRenal and urinary disorders | 0/97 | 1/52 | 0/62 | 0/28 | 0/28 |
| Renal failureRenal and urinary disorders | 0/97 | 1/52 | 0/62 | 0/28 | 0/28 |
| AnxietyPsychiatric disorders | 0/97 | 0/52 | 1/62 | 0/28 | 0/28 |
| Diverticulum intestinalGastrointestinal disorders | 0/97 | 0/52 | 1/62 | 0/28 | 0/28 |
| NeuritisNervous system disorders | 1/97 | 0/52 | 0/62 | 0/28 | 0/28 |
| Optic neuritisNervous system disorders | 1/97 | 0/52 | 0/62 | 0/28 | 0/28 |
| Event | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control (Day 0 to 120) - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System |
|---|---|---|---|---|---|
| HypoglycaemiaMetabolism and nutrition disorders | 2/97 | 1/52 | 4/62 | 1/28 | 1/28 |
| Age, Continuous(Years) | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) | Total |
|---|---|---|---|---|---|
| Mean | 43.7 ± 13.8 | 41.1 ± 13.0 | 45.1 ± 14.1 | 47.7 ± 12.7 | 44.0 ± 13.7 |
| Sex: Female, Male(Participants) | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) | Total |
|---|---|---|---|---|---|
| Female | 55 | 27 | 17 | 8 | 107 |
| Male | 42 | 25 | 45 | 20 | 132 |
| Race and Ethnicity Not Collected(Participants) | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Type of Diabetes(Participants) | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) | Total |
|---|---|---|---|---|---|
| Type 1 Diabetes | 84 | 46 | 62 | 28 | 220 |
| Type 2 Diabetes | 13 | 6 | 0 | 0 | 19 |
| Hemoglobin A1c (HbA1c, %) Levels at Baseline(HbA1c (%)) | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) | Total |
|---|---|---|---|---|---|
| Mean | 9.0 ± 0.9 | 9.1 ± 0.9 | 7.3 ± 0.8 | 6.9 ± 1.0 | 8.3 ± 1.3 |
| Percentage of Time Spent in Hypoglycemia (<54 mg/dL) From Day 0 to Day 30(Percentage of time) | Cohort 1, Enabled - Eversense XL CGM System | Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) | Cohort 2, Enabled - Eversense XL CGM System | Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) | Total |
|---|---|---|---|---|---|
| Mean | 1.2 ± 1.8 | 1.4 ± 2.4 | 4.7 ± 4.0 | 5.4 ± 4.5 | 2.6 ± 3.0 |
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Hoffmann-La Roche