Adult Accuracy Study of the Enlite 3 Glucose Sensor

Type 2 Diabetes Clinical Trial

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Official title:

A Performance Evaluation of the Enlite® 3 Sensor to Support a Full 168 Hours (7 Days) of Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02246582
• Other study ID #: CEP292
• Status: Completed
• Phase: N/A
• First received: September 11, 2014
• Last updated: October 31, 2016
• Start date: September 2014
• Est. completion date: August 2015

Study information

• Verified date: October 2016
• Source: Medtronic Diabetes
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	Barbara Davis Center	Aurora	Colorado
United States	Barbara Davis Center for Childhood Diabetes	Aurora	Colorado
United States	AMCR Institute	Escondido	California
United States	Rainier Clinical Research Center	Renton	Washington
United States	Diablo Clinical Research	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Diabetes

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD)	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.	7 Days	No
Secondary	Retrospective Re-Analysis (MARD With 1 Additional Calibration)	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.	7 Days	No
Secondary	Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration)	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.	7 Days	No