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

• ClinicalTrials.gov Identifier: NCT01464346
• Recruitment Status: Completed
• First Posted: November 3, 2011
• Results First Posted: May 30, 2018
• Last Update Posted: May 30, 2018
• Sponsor: Medtronic Diabetes
• Information provided by (Responsible Party): Medtronic Diabetes

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus	Device: Enlite Sensor	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Performance Evaluation of the Enlite Glucose Sensor to Support a Full 144 Hours(6Days) of Use
• Study Start Date: November 2011
• Actual Primary Completion Date: March 2012
• Actual Study Completion Date: March 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Enlite sensor, Abdomen/Abdomen; Subjects wearing 2 Enlite sensors in Abdomen	Device: Enlite Sensor; This is the Enlite sensor (all subjects)
Experimental: Enlite sensor, Abdomen/Buttock; Subjects wearing 2 Enlite sensors in Abdomen/Buttock	Device: Enlite Sensor; This is the Enlite sensor (all subjects)
Experimental: Enlite sensor, Buttock/Buttock; Subjects wearing 2 Enlite sensors in Buttock/Buttock	Device: Enlite Sensor; This is the Enlite sensor (all subjects)

Outcome Measures

Primary Outcome Measures :

1. Mean Daily Agreement (Percent of Sensor Values Within 30% of Reference Value) With Minimum Calibration, Combined Abdomen and Buttock Insertion Sites [ Time Frame: 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 Outcome Measures :

1. Mean Daily Agreement (Percent of Sensor Values Within 30% of Reference Value) With 3-4 Calibrations Per Day, Combined Abdomen and Buttock Insertion [ Time Frame: 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 Outcome Measures:

1. Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Abdomen Insertion Site, With 3-4 Calibrations Throughout the Day [ Time Frame: 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
2. Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Abdomen Insertion Site, With Calibration Every 12 Hours [ Time Frame: 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
3. Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Buttock Insertion Site, With 3-4 Calibrations Throughout the Day [ Time Frame: 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
4. Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Buttock Insertion Site, With Calibration Every 12 Hours [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

Profil Institute for Clinical Research

Chula Vista, California, United States, 91911

AMCR Institue

Escondido, California, United States, 92026

University of California, San Diego

La Jolla, California, United States, 92093

Diablo Clinical Research

Walnut Creek, California, United States, 94598

United States, Colorado

University of Colorado Denver/Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, United States, 80045

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

United States, Washington

Rainier Clinical Research Center

Renton, Washington, United States, 98057

Sponsors and Collaborators

Medtronic Diabetes

Investigators

• Study Director: Scott Lee, MD; Medtronic Diabetes

More Information

• Responsible Party: Medtronic Diabetes
• ClinicalTrials.gov Identifier: NCT01464346
• Other Study ID Numbers: CEP247
• First Posted: November 3, 2011
• Results First Posted: May 30, 2018
• Last Update Posted: May 30, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Medtronic Diabetes:

diabetes; glucose sensor; CGM

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases