Type 1 Diabetes, Type 2 Diabetes
Conditions
Keywords
Type 1 Diabetes, Type 2 Diabetes, Enlite 3
Brief summary
The purpose of this study is to demonstrate the performance of the Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen and used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years with type 1 or type 2 diabetes.
Detailed description
This study is a multi-center, randomized, in-clinic trial that aims to demonstrate the performance of the Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen and used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years with type 1 or type 2 diabetes for at least one year. Subjects are randomized into either Group A or Group B. The groups assigned will determine when the subject will be participating in the in-clinic YSI frequent sample testing (FST). For example on Day 1: Group A begins FST 30 minutes after Enlite 3 Sensor Insertion. Group B begins FST 14 hours after Enlite 3 Sensor Insertion.
Interventions
DEVICEEnlite 3
Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.
DEVICEGuardian Mobile App
DEVICE640G Insulin Pump
Sponsors
Medtronic Diabetes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is 14-75 years of age at time of screening 2. A clinical diagnosis of type 1 or type 2 diabetes for a minimum of 12 months duration as determined via medical record or source documentation by an individual qualified to make a medical diagnosis 3. Adequate venous access as assessed by investigator or appropriate staff 4. Subjects participating in the high and low glucose challenges must have an established insulin carbohydrate ratio(s) and insulin sensitivity ratio. (The term established refers to a ratio that has been previously defined and tested prior to screening visit). Subjects without established ratios may participate under observation only.
Exclusion criteria
1. Subject will not tolerate tape adhesive in the area of Enlite 3 Sensor placement as assessed by qualified individual 2. Subject has any unresolved adverse skin condition in the area of the Enlite 3 Sensor or device placement (e.g. psoriasis, rash, Staphylococcus infection) 3. Subject is actively participating in an investigational study (drug or device) in the last 2 weeks 4. Subject is female and has a positive pregnancy screening test 5. Females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by the investigator 6. Subject is female and plans to become pregnant during the course of the study 7. Subject has had a hypoglycemic seizure within the past 6 months 8. Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit 9. Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit 10. Subject has a history of a seizure disorder 11. Subject has central nervous system or cardiac disorder resulting in syncope 12. Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease 13. Subject has a hematocrit (Hct) lower than the normal reference range 14. Subject has a history of adrenal insufficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD) | 7 Days | Enlite 3 Sensor accuracy using two real time devices: 1) 640G Pump and 2) Guardian Mobile with the minimum calibration requirements (every 12 hours after the second calibration) will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) \* 100). Note that results from multiple testing days will be pooled together for reporting purpose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retrospective Re-Analysis (MARD With 1 Additional Calibration) | 7 Days | Retrospective re-analysis to simulate 640G Pump and Guardian Mobile 1-minute raw data collected by GST3C Transmitters and GST4C Transmitter: Enlite 3 Sensor accuracy with 3-4 calibrations throughout the day (derived from re-analysis of Enlite 3 Sensor data using actual fingerstick values). Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) \* 100). Note that results from multiple testing days will be pooled together for reporting purpose. |
| Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration) | 7 Days | Retrospective analysis using one GSR: minimum and 3-4 calibrations will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values during YSI frequent sample testing. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) \* 100). Note that results from multiple testing days will be pooled together for reporting purpose. |
Countries
United States
Participant flow
Pre-assignment details
118 subjects consented and enrolled in the overall study. Of the 118, 89 subjects utilized the latest sensor version.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.
Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.
Guardian Mobile App
640G Insulin Pump | 89 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Categorical <=18 years | 14 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 62 Participants |
| Age, Continuous | 41.7 years STANDARD_DEVIATION 19.14 |
| Gender Female | 43 Participants |
| Gender Male | 46 Participants |
| Region of Enrollment United States | 89 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 89 |
| serious Total, serious adverse events | 0 / 89 |
Outcome results
Primary
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD)
Enlite 3 Sensor accuracy using two real time devices: 1) 640G Pump and 2) Guardian Mobile with the minimum calibration requirements (every 12 hours after the second calibration) will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) \* 100). Note that results from multiple testing days will be pooled together for reporting purpose.
Time frame: 7 Days
Population: Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group | Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD) | 640G Pump | 10.55 percentage | Standard Deviation 9.62 |
| Group | Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD) | Guardian Mobile | 10.35 percentage | Standard Deviation 10.39 |
Secondary
Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration)
Retrospective analysis using one GSR: minimum and 3-4 calibrations will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values during YSI frequent sample testing. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) \* 100). Note that results from multiple testing days will be pooled together for reporting purpose.
Time frame: 7 Days
Population: Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group | Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration) | minimum calibration | 9.09 percentage | Standard Deviation 8.29 |
| Group | Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration) | 3-4 calibrations | 8.68 percentage | Standard Deviation 7.95 |
Secondary
Retrospective Re-Analysis (MARD With 1 Additional Calibration)
Retrospective re-analysis to simulate 640G Pump and Guardian Mobile 1-minute raw data collected by GST3C Transmitters and GST4C Transmitter: Enlite 3 Sensor accuracy with 3-4 calibrations throughout the day (derived from re-analysis of Enlite 3 Sensor data using actual fingerstick values). Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) \* 100). Note that results from multiple testing days will be pooled together for reporting purpose.
Time frame: 7 Days
Population: Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group | Retrospective Re-Analysis (MARD With 1 Additional Calibration) | 640G Pump | 9.64 percentage | Standard Deviation 9.04 |
| Group | Retrospective Re-Analysis (MARD With 1 Additional Calibration) | Guardian Mobile | 9.43 percentage | Standard Deviation 9.83 |