An interventional study of Dexcom continuous glucose monitor in Type 2 Diabetes, sponsored by Ian J. Neeland, MD. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by Ian J. Neeland, MD · Not applicable, Interventional, and Supportive care
The objective of this study is to evaluate the feasibility and clinical utility of a continuous glucose monitoring device (CGM, Dexcom G6) for the care of patients with type 2 diabetes who are on non-insulin therapies.
The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.
This investigation is a 2-phase sequential study with patients serving as their own controls. The demographics, medical history, anthropometric and laboratory data are collected at baseline for each patient. During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention.
During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Anthropometric and laboratory data (including HB A1c) are collected. Medical providers are also un-blinded and adjust medical recommendations and interventions, in part based on CGM data, as appropriate.
All patients will receive usual care which will include individual and virtual lifestyle education, virtual support group, M.D. visits, medication interventions, referrals to support programs outside the scope of CINEMA program and nursing support
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 56 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention. During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase.
Device: Dexcom continuous glucose monitor
The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.
Change in Average Glucose Levels as Measured by Continuous Glucose Monitor
Average glucose on CGM
Time frame: 0, 30, 60, 90 days
Change in Time in Range as Measured by Continuous Glucose Monitor
Time in range is the time spent in the acceptable glucose range between 80-180 mg/dl. This time in range is noted as a proportion of time that the blood glucose is in this range out of the total time. So if the person's glucose is in this range 70% of the time (and out of it 30%), then Time in Range is 70%.
Time frame: 0, 30, 60, 90 days
Change in Glucose Variability as Measured by Continuous Glucose Monitor
Glucose variability on CGM is defined as standard deviation of the all recorded glucose values.
Time frame: 0, 30, 60, 90 days
Change in Hemoglobin A1c From Blood Test
Glycosylated hemoglobin
Time frame: 0 and 90 days
Change in Total Cholesterol From Blood Test
Total cholesterol
Time frame: 0 and 90 days
Change in Low Density Lipoprotein Cholesterol From Blood Test
LDL-C
Time frame: 0 and 90 days
Change in High Density Lipoprotein Cholesterol From Blood Test
HDL-C
Time frame: 0 and 90 days
Change in Triglycerides From Blood Test
Triglycerides
Time frame: 0 and 90 days
Change in Body Mass Index From Height and Weight
BMI
Time frame: 0 and 90 days
Change in Systolic Blood Pressure From Automated Cuff
Systolic blood pressure
Time frame: 0 and 90 days
Change in Diastolic Blood Pressure From Automated Cuff
Diastolic blood pressure
Time frame: 0 and 90 days
Picture Your Plate Dietary Assessment Questionnaire
Picture Your PlateTM is a brief (48-question) dietary assessment questionnaire developed to assess how well an individual's eating habits align with current evidence-based recommendations. Picture Your Plate provides a total score ranging from 0 to 96, with a higher score indicating healthier food choice awareness.
Time frame: 0, 90 days
Type 2 Diabetes Distress Screening Scale (T2-DDAS)
The T2-DDAS is a self-report survey that has 29 items. Each item rated on a 1 to 5 scale: Mean score \< 2.0 indicate little or no distress. Mean score between 2.0 and 2.9 indicate moderate distress. Mean score \> 3.0 indicate high distress
Time frame: 0, 90 days
International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires. Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. This measure assesses the types of intensity of physical activity that people do as part of their daily lives. The estimate is measured as total physical activity in MET-min/week. Lower scores mean less total amount and intensity of physical activity and higher scores mean greater total amount and intensity of physical activity in a given week.
Time frame: 0, 90 days
Glucose Monitoring Satisfaction Survey
The GMSS is a reliable, valid measure of glucose device satisfaction in its T1D form and in its insulin-using T2D form. It provides a comprehensive profile of sources of device satisfaction for use in clinical care and research.
Time frame: 90 days
| Milestone | Dexcom G6 Continuous Glucose Monitoring Device |
|---|---|
| Started | 56 |
| Completed | 47 |
| Not completed | 9 |
| Withdrew: Unable to contact | 2 |
| Withdrew: High stress, did not want to continue | 1 |
| Withdrew: Technical issues with device | 4 |
| Withdrew: Did not meet eligibility criteria | 2 |
| Milestone | Dexcom G6 Continuous Glucose Monitoring Device |
|---|---|
| Started | 47 |
| Completed | 47 |
| Not completed | 0 |
Average glucose on CGM
| mg/dl | Blinded Followed by Unblinded |
|---|---|
| Day 0 | 184 ± 55.7 |
| Day 30 | 148.6 ± 45.4 |
| Day 60 | 144.8 ± 45.3 |
| Day 90 | 147.2 ± 44.7 |
Time in range is the time spent in the acceptable glucose range between 80-180 mg/dl. This time in range is noted as a proportion of time that the blood glucose is in this range out of the total time. So if the person's glucose is in this range 70% of the time (and out of it 30%), then Time in Range is 70%.
| percentage of time in range | Blinded Followed by Unblinded |
|---|---|
| Day 0 | 57.8 ± 32.5 |
| Day 30 | 82 ± 22.7 |
| Day 60 | 83.8 ± 23.8 |
| Day 90 | 82.5 ± 24.6 |
Glucose variability on CGM is defined as standard deviation of the all recorded glucose values.
| mg/dl | Blinded Followed by Unblinded |
|---|---|
| Day 0 | 26.2 ± 8.9 |
| Day 30 | 24.1 ± 7.5 |
| Day 60 | 24.1 ± 7.7 |
| Day 90 | 24 ± 6.6 |
Glycosylated hemoglobin
| percentage of Glycosylated hemoglobin | Blinded Followed by Unblinded |
|---|---|
| Day 0 | 8.4 ± 1.8 |
| Day 90 | 6.9 ± 1.2 |
Total cholesterol
| mg/dl | Blinded Followed by Unblinded |
|---|---|
| Day 0 | 162.6 ± 45.6 |
| Day 90 | 143.6 ± 45.2 |
LDL-C
| mg/dl | Blinded Followed by Unblinded |
|---|---|
| Day 0 | 82.8 ± 37 |
| Day 90 | 73.6 ± 38.5 |
HDL-C
| mg/dl | Blinded Followed by Unblinded |
|---|---|
| Day 0 | 45.5 ± 12.4 |
| Day 90 | 43.9 ± 10.5 |
Triglycerides
| mg/dl | Blinded Followed by Unblinded |
|---|---|
| Day 0 | 173.3 ± 110.4 |
| Day 90 | 131.2 ± 69.7 |
BMI
| kg/m2 | Blinded Followed by Unblinded |
|---|---|
| Day 0 | 37.7 ± 6.1 |
| Day 90 | 34.9 ± 5.9 |
Systolic blood pressure
| mmHg | Blinded Followed by Unblinded |
|---|---|
| Day 0 | 134.8 ± 16.3 |
| Day 90 | 126.0 ± 15.2 |
Diastolic blood pressure
| mmHg | Blinded Followed by Unblinded |
|---|---|
| Day 0 | 79.4 ± 6.7 |
| Day 90 | 75.8 ± 7.3 |
Picture Your PlateTM is a brief (48-question) dietary assessment questionnaire developed to assess how well an individual's eating habits align with current evidence-based recommendations. Picture Your Plate provides a total score ranging from 0 to 96, with a higher score indicating healthier food choice awareness.
| score on a scale | Blinded Followed by Unblinded |
|---|---|
| Day 0 | 61 ± 12.4 |
| Day 90 | 65.5 ± 17.7 |
The T2-DDAS is a self-report survey that has 29 items. Each item rated on a 1 to 5 scale: Mean score \< 2.0 indicate little or no distress. Mean score between 2.0 and 2.9 indicate moderate distress. Mean score \> 3.0 indicate high distress
| score on a scale | Blinded Followed by Unblinded |
|---|---|
| Day 0 | 2.4 ± 0.9 |
| Day 90 | 1.6 ± 0.5 |
The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires. Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. This measure assesses the types of intensity of physical activity that people do as part of their daily lives. The estimate is measured as total physical activity in MET-min/week. Lower scores mean less total amount and intensity of physical activity and higher scores mean greater total amount and intensity of physical activity in a given week.
| minutes per week | Blinded Followed by Unblinded |
|---|---|
| Day 0 | 2864.8 ± 3329 |
| Day 90 | 3445.4 ± 3040 |
The GMSS is a reliable, valid measure of glucose device satisfaction in its T1D form and in its insulin-using T2D form. It provides a comprehensive profile of sources of device satisfaction for use in clinical care and research.
No measurements were reported for this outcome.
Collected over From Baseline through end of the Unblinded Phase, approximately 100 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Blinded | 0/56 (0%) | 0/56 (0%) | 0/56 (0%) |
| Unblinded | 0/47 (0%) | 0/47 (0%) | 0/47 (0%) |
2 people did not meet eligibility criteria. They were consented but did not participate in the study. A total of 56 participants signed consents and only 47 fully completed both phases of the study.
| Age, Continuous(years) | Blinded Followed by Unblinded |
|---|---|
| Mean | 63 ± 9.7 |
| Sex: Female, Male(Participants) | Blinded Followed by Unblinded |
|---|---|
| Female | 24 |
| Male | 32 |
| Ethnicity (NIH/OMB)(Participants) | Blinded Followed by Unblinded |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 54 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Blinded Followed by Unblinded |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 19 |
| White | 32 |
| More than one race | 0 |
| Unknown or Not Reported | 5 |
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Ian J. Neeland, MD