An interventional study of Enlite Sensor in Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, sponsored by Medtronic Diabetes. Completed at 7 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-05-30.
Sponsored by Medtronic Diabetes · Not applicable, Interventional, and Other
The purpose of this study is to demonstrate the performance of the Enlite Sensor over an entire calibration and wear period of 146 hours (6 days) when inserted in the abdomen and buttock and used with the Revel 2.0 Pumps in subjects age 18 - 75 years.
The study is a multi-center, prospective single-sample correlational design without controls. Between 4 and 10 investigational sites will be used during this study. All subjects will be assigned to treatment. Each subject will wear the following devices:
During the study each subject will be wearing 2 sensors and 2 pumps simultaneously. The pumps will be differentiated by color, and will have different calibration requirements during the in-clinic portions of the study. During the Frequent Sampling Tests:
During home use (outside the clinic) BOTH pumps will be calibrated 3-4 times spread throughout the day.
Sensors will be connected to the MiniLink (integrated with the Revel 2.0 Pumps)
Subjects will wear the devices for a 3-day training period, followed by a 6-day study period. During the study period, each subject will undergo three 12-hour Frequent Sampling Tests. During the Frequent Sampling Tests, IV blood samples will be drawn every 5-15 minutes and analyzed using the YSI. The Frequent Sampling Tests will occur during the following hours of sensor wear: hours 2-14, hours 14-26, hours 50-62 hours 62-74, and hours 122-134 hours 134-146 which is representative of a complete calibration and wear period to support the proposed labeling claim of 144 hours of use.
Even though participants were randomly assigned with respect to timing of frequent sample test and sensor insertion locations, data was collected as a whole and there was no intention to analyze the two groups separately. Please note that subjects were randomly assigned to one of 3 different sensor insertion site combinations: abdomen/abdomen, buttock/buttock, and abdomen/buttock
During each Frequent Sampling Test, subjects with an established insulin sensitivity ratio and insulin carbohydrate ratio will undergo a hypoglycemic challenge (glucose lowered to a target of 50-75 mg/dL for \~2 hours, including 30 minutes between 50-60 mg/dL) and a hyperglycemic challenge (glucose raised to a target of 180-400 mg/dL for \~2 hours, including 30 minutes between 350 -400 mg/dL). Subjects will continue with their current diabetes regimen (including glucose monitoring with their own meter when desired) independent of the study devices. The Revel 2.0 Pumps will not be used to infuse insulin or manage the subject's diabetes during this study. The Enlite Glucose sensor will not be used to manage the subject's diabetes during this study. The investigational Study Meter may be used for confirmation of alarms, treatment decisions and calibration of sensor.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 90 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Medtronic Diabetes is the lead sponsor of 61 studies on the registry; none are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 21 (95%) have results posted.
Counted across the registry records on this site, refreshed daily.
A clinical diagnosis of type 1 or 2 diabetes as determined by the
Investigator, for a minimum of 12 months duration:
Criteria for type 1 diabetes:
Criteria for type 2 diabetes:
Required: History of being overweight at time of diagnosis.
Exclusion Criteria:
Subjects wearing 2 Enlite sensors in Abdomen
Device: Enlite Sensor
Subjects wearing 2 Enlite sensors in Abdomen/Buttock
Device: Enlite Sensor
Subjects wearing 2 Enlite sensors in Buttock/Buttock
Device: Enlite Sensor
This is the Enlite sensor (all subjects)
Mean Daily Agreement (Percent of Sensor Values Within 30% of Reference Value) With Minimum Calibration, Combined Abdomen and Buttock Insertion Sites
Primary endpoint is mean of daily percentage of sensor values within 30% of reference value (within 22.5 mg/dL if YSI \<75 mg/dL) with the minimum calibration (every 12 hour), combined abdomen and buttock insertion sites across all participants and all days.
Time frame: Days 1, 3 and 6 of sensor wear
Mean Daily Agreement (Percent of Sensor Values Within 30% of Reference Value) With 3-4 Calibrations Per Day, Combined Abdomen and Buttock Insertion
Secondary endpoint is mean of daily percentage of sensor values within 30% of reference value (within 22.5 mg/dL if YSI \<75 mg/dL) with 3-4 calibrations per day, combined abdomen and buttock insertion sites across all participants and all days.
Time frame: Days 1, 3 and 6 of sensor wear
Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Abdomen Insertion Site, With 3-4 Calibrations Throughout the Day
This measure is the Mean Absolute Relative Difference (MARD) between sensor glucose values and and paired YSI plasma glucose values for Abdomen insertion site, with 3-4 Calibrations, across all Abdomen insertion site participants and all days. MARD is calculated by absolute value of \[(sensor glucose value - YSI glucose value) / YSI glucose value\] \* 100
Time frame: Days 1, 3 and 6 of sensor wear
Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Abdomen Insertion Site, With Calibration Every 12 Hours
This is a measure of Mean Absolute Relative Difference (MARD) between the sensor and the paired YSI plasma glucose value for sensors inserted in the Abdomen insertion site, with Calibration every 12 hours, across all Abdomen insertion site participants and all days. MARD is calculated by absolute value of \[(sensor glucose value - YSI glucose value) / YSI glucose value\] \* 100
Time frame: Days 1, 3 and 6 of sensor wear
Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Buttock Insertion Site, With 3-4 Calibrations Throughout the Day
This measure is the Mean Absolute Relative Difference (MARD) between sensor glucose value and paired YSI plasma glucose measurement for sensors inserted in the Buttock insertion site, with 3-4 Calibrations, across all Buttock insertion site participants and all days. MARD is calculated by absolute value of \[(sensor glucose value - YSI glucose value) / YSI glucose value\] \* 100
Time frame: Days 1, 3 and 6 of sensor wear
Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Buttock Insertion Site, With Calibration Every 12 Hours
This measure is the Mean Absolute Relative Difference (MARD) between sensor glucose values and paired YSI plasma glucose values for sensors inserted in the Buttock insertion site, with Calibration every 12 hours, across all Buttock insertion site participants and all days. MARD is calculated by absolute value of \[(sensor glucose value - YSI glucose value) / YSI glucose value\] \* 100
Time frame: Days 1, 3 and 6 of sensor wear
| Milestone | Enlite Sensor Abdomen/Abdomen | Enlite Sensor Abdomen/Buttock | Enlite Sensor Buttock/Buttock |
|---|---|---|---|
| Started | 29 | 32 | 29 |
| Completed | 29 | 32 | 28 |
| Not completed | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 |
Primary endpoint is mean of daily percentage of sensor values within 30% of reference value (within 22.5 mg/dL if YSI \<75 mg/dL) with the minimum calibration (every 12 hour), combined abdomen and buttock insertion sites across all participants and all days.
| percentage of paired readings | All Subjects |
|---|---|
| Mean Daily Agreement (Percent of Sensor Values Within 30% of Reference Value) With Minimum Calibration, Combined Abdomen and Buttock Insertion Sites | 88.01 (85.69 to 90.33) |
Secondary endpoint is mean of daily percentage of sensor values within 30% of reference value (within 22.5 mg/dL if YSI \<75 mg/dL) with 3-4 calibrations per day, combined abdomen and buttock insertion sites across all participants and all days.
| percentage of paired readings | All Subjects |
|---|---|
| Mean Daily Agreement (Percent of Sensor Values Within 30% of Reference Value) With 3-4 Calibrations Per Day, Combined Abdomen and Buttock Insertion | 90.52 (88.77 to 92.28) |
This measure is the Mean Absolute Relative Difference (MARD) between sensor glucose values and and paired YSI plasma glucose values for Abdomen insertion site, with 3-4 Calibrations, across all Abdomen insertion site participants and all days. MARD is calculated by absolute value of \[(sensor glucose value - YSI glucose value) / YSI glucose value\] \* 100
| percentage of difference | All Subjects With Abdomen Insertion |
|---|---|
| Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Abdomen Insertion Site, With 3-4 Calibrations Throughout the Day | 13.6 ± 13.6 |
This is a measure of Mean Absolute Relative Difference (MARD) between the sensor and the paired YSI plasma glucose value for sensors inserted in the Abdomen insertion site, with Calibration every 12 hours, across all Abdomen insertion site participants and all days. MARD is calculated by absolute value of \[(sensor glucose value - YSI glucose value) / YSI glucose value\] \* 100
| percentage of difference | All Subjects With Abdomen Insertion |
|---|---|
| Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Abdomen Insertion Site, With Calibration Every 12 Hours | 14.7 ± 13.7 |
This measure is the Mean Absolute Relative Difference (MARD) between sensor glucose value and paired YSI plasma glucose measurement for sensors inserted in the Buttock insertion site, with 3-4 Calibrations, across all Buttock insertion site participants and all days. MARD is calculated by absolute value of \[(sensor glucose value - YSI glucose value) / YSI glucose value\] \* 100
| percentage of difference | All Subjects With Buttock Insertion |
|---|---|
| Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Buttock Insertion Site, With 3-4 Calibrations Throughout the Day | 15.5 ± 16.0 |
This measure is the Mean Absolute Relative Difference (MARD) between sensor glucose values and paired YSI plasma glucose values for sensors inserted in the Buttock insertion site, with Calibration every 12 hours, across all Buttock insertion site participants and all days. MARD is calculated by absolute value of \[(sensor glucose value - YSI glucose value) / YSI glucose value\] \* 100
| percentage of difference | All Subjects With Buttock Insertion |
|---|---|
| Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Buttock Insertion Site, With Calibration Every 12 Hours | 18.2 ± 23.8 |
Collected over Severe adverse event data and adverse event data were collected during the 2-4 weeks study duration. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Completed Subjects | 0/90 (0%) | 0/90 (0%) | 17/90 (18.9%) |
| Event | All Completed Subjects |
|---|---|
| Upper Respiratory InfectionInfections and infestations | 3/90 |
| SinusitisInfections and infestations | 2/90 |
| Pain in ArmMusculoskeletal and connective tissue disorders | 2/90 |
| NauseaGastrointestinal disorders | 1/90 |
| DiarrheaGastrointestinal disorders | 1/90 |
| Chest PainGeneral disorders | 1/90 |
| Application Site PainGeneral disorders | 1/90 |
| Edema L HandGeneral disorders | 1/90 |
| FluInfections and infestations | 1/90 |
| Skin InfectionInfections and infestations | 1/90 |
| Age, Categorical(Participants) | All Subjects Entering the Study |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 82 |
| >=65 years | 7 |
| Age, Continuous(years) | All Subjects Entering the Study |
|---|---|
| Mean | 44.4 ± 13.8 |
| Sex: Female, Male(Participants) | All Subjects Entering the Study |
|---|---|
| Female | 41 |
| Male | 49 |
| Region of Enrollment(participants) | All Subjects Entering the Study |
|---|---|
| United States | 90 |
Plan to share: No
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