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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01464346

Enrollment

Registered

2011-11-03

Start date

2011-11-30

Completion date

2012-03-31

Last updated

2018-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus

Keywords

diabetes, glucose sensor, CGM

Brief summary

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.

Detailed description

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: 1. Enlite Sensors (2) connected to MiniLinks (2) 2. Revel 2.0 Pumps (2) 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: * GREEN pump will be calibrated 3-4 times spread throughout the day * RED pump will have the minimum calibration requirements (every 12 hours after the second calibration) 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.

Interventions

DEVICEEnlite Sensor

This is the Enlite sensor (all subjects)

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Subject is 18 - 75 years of age at time of screening 2. 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: * Required: Age of onset \< 40 years of age * Required: History of insulin use only for management of diabetes * Required: history of normal weight or underweight at time of diagnosis. * Not required: Initial presentation of diabetic ketoacidosis. * Not required: History of diabetic ketoacidosis * Not required: Low fasting C-peptide * Criteria for type 2 diabetes: * Required: Age of onset \ 40 years of age * Required: History of initial oral anti-diabetic use * Required: History of being overweight at time of diagnosis. * Type 2 insulin requiring is defined by type 2 diabetes subjects taking insulin with or without oral anti-diabetic agent and may also include: incretin mimetic, pramlintide or GLP agonist * Type 2 non-insulin requiring is defined by type 2 diabetes subjects who take oral medications and may also include: incretin mimetic, pramlintide or GLP agonist 3. Adequate venous access as assessed by investigator or appropriate staff

Exclusion criteria

1. Subject is unable to tolerate tape adhesive in the area of sensor placement. 2. Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection) 3. Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks 4. Subject has a positive pregnancy screening test 5. Subject is female and plans to become pregnant during the course of the study 6. Subject has had a hypoglycemic seizure within the past 6 months 7. Subject has a history of a seizure disorder 8. Subject has central nervous system or cardiac disorder resulting in syncope 9. 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 10. Subjects with hematocrit lower than 36% 11. SUbjects with a history of any cardiac arrhythmia, including atrial arrhythmias 12. Subjects with a history of adrenal insufficiency 13. Subjects with migraines

Design outcomes

Primary

Measure	Time frame	Description
Mean Daily Agreement (Percent of Sensor Values Within 30% of Reference Value) With Minimum Calibration, Combined Abdomen and Buttock Insertion Sites	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.

Secondary

Measure	Time frame	Description
Mean Daily Agreement (Percent of Sensor Values Within 30% of Reference Value) With 3-4 Calibrations Per Day, Combined Abdomen and Buttock Insertion	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.

Other

Measure	Time frame	Description
Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Abdomen Insertion Site, With 3-4 Calibrations Throughout the Day	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
Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Abdomen Insertion Site, With Calibration Every 12 Hours	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
Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Buttock Insertion Site, With 3-4 Calibrations Throughout the Day	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
Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Buttock Insertion Site, With Calibration Every 12 Hours	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

Countries

United States

Participant flow

Participants by arm

Arm	Count
All Subjects Entering the Study All Subjects who provided consent, met inclusion/exclusion criteria and worn Enlite sensors	90
Total	90

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Withdrawal by Subject	0	0	1

Baseline characteristics

Characteristic	All Subjects Entering the Study
Age, Categorical <=18 years	1 Participants
Age, Categorical >=65 years	7 Participants
Age, Categorical Between 18 and 65 years	82 Participants
Age, Continuous	44.4 years STANDARD_DEVIATION 13.8
Region of Enrollment United States	90 participants
Sex: Female, Male Female	41 Participants
Sex: Female, Male Male	49 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 90
other Total, other adverse events	17 / 90
serious Total, serious adverse events	0 / 90

Outcome results

Primary

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.