Clinical trial NCT02246582: Adult Accuracy Study of the Enlite 3 Glucose Sensor
Official title: A Performance Evaluation of the Enlite® 3 Sensor to Support a Full 168 Hours (7 Days) of Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Type 2 Diabetes
Keywords: Type 1 Diabetes
Type 2 Diabetes
Enlite 3
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2014-09-23
Enrollment: 118
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD)
timeFrame: 7 Days
Secondary outcomes:
measure: Retrospective Re-Analysis (MARD With 1 Additional Calibration)
timeFrame: 7 Days
measure: Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration)
timeFrame: 7 Days
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Aurora
country: United States
facility: Barbara Davis Center for Childhood Diabetes
state: Colorado
city: Aurora
country: United States
facility: Barbara Davis Center
state: Colorado
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
Study officials:
affiliation: Rainier Clinical Research Center
name: Ronald Brazg, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Diablo Clinical Research
name: Mark Christiansen, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: AMCR Institute
name: Timothy Bailey, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Barbara Davis Center
name: Satish Garg, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Barbara Davis Center
name: Robert Slover, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Atlanta Diabetes Associates
name: Bruce Bode, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christiansen MP, Garg SK, Brazg R, Bode BW, Bailey TS, Slover RH, Sullivan A, Huang S, Shin J, Lee SW, Kaufman FR. Accuracy of a Fourth-Generation Subcutaneous Continuous Glucose Sensor. Diabetes Technol Ther. 2017 Aug;19(8):446-456. doi: 10.1089/dia.2017.0087. Epub 2017 Jul 12.