Trial Outcomes & Findings for A Performance Evaluation of the Enlite Glucose Sensor to Support a Full 144 Hours(6Days) of Use (NCT NCT01464346)

NCT ID: NCT01464346

Last Updated: 2018-05-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

90 participants

Primary outcome timeframe

Days 1, 3 and 6 of sensor wear

Results posted on

2018-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	Enlite Sensor Abdomen/Abdomen Subjects wearing 2 Enlite sensors in abdomen. Some subjects participated in Frequent Sampling Tests during the first 12 hours of days 1, 3 and 6 while others participated during the last 12 hours of days 1, 3, and 6.	Enlite Sensor Abdomen/Buttock Subjects wearing one Enlite sensor in Abdomen and one Enlite sensor in Buttock. Some subjects participated in Frequent Sampling Tests during the first 12 hours of days 1, 3 and 6 while others participated during the last 12 hours of days 1, 3, and 6.	Enlite Sensor Buttock/Buttock Subjects wearing 2 Enlite sensors in Buttock. Some subjects participated in Frequent Sampling Tests during the first 12 hours of days 1, 3 and 6 while others participated during the last 12 hours of days 1, 3, and 6.
Overall Study STARTED	29	32	29
Overall Study COMPLETED	29	32	28
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Enlite Sensor Abdomen/Abdomen Subjects wearing 2 Enlite sensors in abdomen. Some subjects participated in Frequent Sampling Tests during the first 12 hours of days 1, 3 and 6 while others participated during the last 12 hours of days 1, 3, and 6.	Enlite Sensor Abdomen/Buttock Subjects wearing one Enlite sensor in Abdomen and one Enlite sensor in Buttock. Some subjects participated in Frequent Sampling Tests during the first 12 hours of days 1, 3 and 6 while others participated during the last 12 hours of days 1, 3, and 6.	Enlite Sensor Buttock/Buttock Subjects wearing 2 Enlite sensors in Buttock. Some subjects participated in Frequent Sampling Tests during the first 12 hours of days 1, 3 and 6 while others participated during the last 12 hours of days 1, 3, and 6.
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

A Performance Evaluation of the Enlite Glucose Sensor to Support a Full 144 Hours(6Days) of Use

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects Entering the Study n=90 Participants All Subjects who provided consent, met inclusion/exclusion criteria and worn Enlite sensors
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	82 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	44.4 years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants
Region of Enrollment United States	90 participants n=5 Participants

PRIMARY outcome

Timeframe: Days 1, 3 and 6 of sensor wear

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.

Outcome measures

Outcome measures
Measure	All Subjects n=90 Participants This group contains all subjects that enrolled in the study
Mean Daily Agreement (Percent of Sensor Values Within 30% of Reference Value) With Minimum Calibration, Combined Abdomen and Buttock Insertion Sites	88.01 percentage of paired readings Interval 85.69 to 90.33

SECONDARY outcome

Timeframe: Days 1, 3 and 6 of sensor wear

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.

Outcome measures

Outcome measures
Measure	All Subjects n=90 Participants This group contains all subjects that enrolled in the study
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 percentage of paired readings Interval 88.77 to 92.28

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 1, 3 and 6 of sensor wear

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

Outcome measures

Outcome measures
Measure	All Subjects n=61 Participants This group contains all subjects that enrolled in the study
Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Abdomen Insertion Site, With 3-4 Calibrations Throughout the Day	13.6 percentage of difference Standard Deviation 13.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 1, 3 and 6 of sensor wear

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

Outcome measures

Outcome measures
Measure	All Subjects n=61 Participants This group contains all subjects that enrolled in the study
Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Abdomen Insertion Site, With Calibration Every 12 Hours	14.7 percentage of difference Standard Deviation 13.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 1, 3 and 6 of sensor wear

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

Outcome measures

Outcome measures
Measure	All Subjects n=61 Participants This group contains all subjects that enrolled in the study
Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Buttock Insertion Site, With 3-4 Calibrations Throughout the Day	15.5 percentage of difference Standard Deviation 16.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 1, 3 and 6 of sensor wear

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

Outcome measures

Outcome measures
Measure	All Subjects n=61 Participants This group contains all subjects that enrolled in the study
Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Buttock Insertion Site, With Calibration Every 12 Hours	18.2 percentage of difference Standard Deviation 23.8

Adverse Events

All Completed Subjects

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Completed Subjects n=90 participants at risk All subjects that completed the study
Gastrointestinal disorders Nausea	1.1% 1/90 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 2-4 weeks study duration
Gastrointestinal disorders Diarrhea	1.1% 1/90 • Number of events 2 • Severe adverse event data and adverse event data were collected during the 2-4 weeks study duration
General disorders Chest Pain	1.1% 1/90 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 2-4 weeks study duration
General disorders Application Site Pain	1.1% 1/90 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 2-4 weeks study duration
General disorders Edema L Hand	1.1% 1/90 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 2-4 weeks study duration
Infections and infestations Upper Respiratory Infection	3.3% 3/90 • Number of events 3 • Severe adverse event data and adverse event data were collected during the 2-4 weeks study duration
Infections and infestations Flu	1.1% 1/90 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 2-4 weeks study duration
Infections and infestations Sinusitis	2.2% 2/90 • Number of events 2 • Severe adverse event data and adverse event data were collected during the 2-4 weeks study duration
Infections and infestations Skin Infection	1.1% 1/90 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 2-4 weeks study duration
Metabolism and nutrition disorders Hypoglycemia	1.1% 1/90 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 2-4 weeks study duration
Musculoskeletal and connective tissue disorders Pain in Arm	2.2% 2/90 • Number of events 4 • Severe adverse event data and adverse event data were collected during the 2-4 weeks study duration
Musculoskeletal and connective tissue disorders Shoulder Pain	1.1% 1/90 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 2-4 weeks study duration
Musculoskeletal and connective tissue disorders Arm Discomfort	1.1% 1/90 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 2-4 weeks study duration
Nervous system disorders Headache	1.1% 1/90 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 2-4 weeks study duration
Nervous system disorders Sinus Headache	1.1% 1/90 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 2-4 weeks study duration

Additional Information

Pamela Haworth

Medtronic Diabetes Clinical Research

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60