Trial Outcomes & Findings for Adult Accuracy Study of the Enlite 3 Glucose Sensor (NCT NCT02246582)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

118 participants

Primary outcome timeframe

7 Days

Results posted on

2016-11-02

Participant Flow

118 subjects consented and enrolled in the overall study. Of the 118, 89 subjects utilized the latest sensor version.

Participant milestones

Participant milestones
Measure	Group A (FST 30 Mins After Sensor Insertion) 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	Group B (FST 14 Hrs After Sensor Insertion) 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
Overall Study STARTED	44	45
Overall Study COMPLETED	41	41
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A (FST 30 Mins After Sensor Insertion) 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	Group B (FST 14 Hrs After Sensor Insertion) 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
Overall Study Withdrawal by Subject	3	4

Baseline Characteristics

Adult Accuracy Study of the Enlite 3 Glucose Sensor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=89 Participants 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
Age, Categorical <=18 years	14 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	62 Participants n=93 Participants
Age, Categorical >=65 years	13 Participants n=93 Participants
Age, Continuous	41.7 years STANDARD_DEVIATION 19.14 • n=93 Participants
Gender Female	43 Participants n=93 Participants
Gender Male	46 Participants n=93 Participants
Region of Enrollment United States	89 participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Group n=89 Participants 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
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD) 640G Pump	10.55 percentage Standard Deviation 9.62
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD) Guardian Mobile	10.35 percentage Standard Deviation 10.39

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Group n=89 Participants 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
Retrospective Re-Analysis (MARD With 1 Additional Calibration) 640G Pump	9.64 percentage Standard Deviation 9.04
Retrospective Re-Analysis (MARD With 1 Additional Calibration) Guardian Mobile	9.43 percentage Standard Deviation 9.83

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Group n=89 Participants 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
Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration) minimum calibration	9.09 percentage Standard Deviation 8.29
Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration) 3-4 calibrations	8.68 percentage Standard Deviation 7.95

Adverse Events

Group

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Group n=89 participants at risk 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
Infections and infestations Gastroenteritis	1.1% 1/89 • Number of events 1 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.
Reproductive system and breast disorders worsening of BPH	1.1% 1/89 • Number of events 1 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.
Skin and subcutaneous tissue disorders RASH	1.1% 1/89 • Number of events 1 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.
Infections and infestations Upper respiratory infection	1.1% 1/89 • Number of events 1 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.
Skin and subcutaneous tissue disorders Blister	1.1% 1/89 • Number of events 1 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.

Additional Information

Smita Barua, Clinical Trial Manager

Medtronic Diabtes

Phone: 818.576.5534

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60