Adult Accuracy Study of the Enlite 3 Glucose Sensor
E3
A Performance Evaluation of the Enlite® 3 Sensor to Support a Full 168 Hours (7 Days) of Use
1 other identifier
interventional
118
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2014
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 11, 2014
CompletedFirst Posted
Study publicly available on registry
September 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
November 2, 2016
CompletedNovember 2, 2016
October 1, 2016
11 months
September 11, 2014
August 24, 2016
October 31, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Retrospective Re-Analysis (MARD With 1 Additional Calibration)
7 Days
Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration)
7 Days
Study Arms (2)
Group A
OTHERSubjects underwent FST at 30 mins, 50 hrs and 146 hrs from Enlite 3 Sensors connected to GST3C, GST4C Transmitter, and GSR
Group B
OTHERSubjects underwent FST at 14 hrs, 62 hrs and 158 hrs from Enlite 3 Sensors connected to GST3C, GST4C Transmitter, and GSR
Interventions
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.
Eligibility Criteria
You may qualify if:
- Subject is 14-75 years of age at time of screening
- 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
- Adequate venous access as assessed by investigator or appropriate staff
- 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.
You may not qualify if:
- Subject will not tolerate tape adhesive in the area of Enlite 3 Sensor placement as assessed by qualified individual
- Subject has any unresolved adverse skin condition in the area of the Enlite 3 Sensor or device placement (e.g. psoriasis, rash, Staphylococcus infection)
- Subject is actively participating in an investigational study (drug or device) in the last 2 weeks
- Subject is female and has a positive pregnancy screening test
- 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
- Subject is female and plans to become pregnant during the course of the study
- Subject has had a hypoglycemic seizure within the past 6 months
- Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit
- Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit
- Subject has a history of a seizure disorder
- Subject has central nervous system or cardiac disorder resulting in syncope
- 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
- Subject has a hematocrit (Hct) lower than the normal reference range
- Subject has a history of adrenal insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
AMCR Institute
Escondido, California, 92026, United States
Diablo Clinical Research
Walnut Creek, California, 94598, United States
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045, United States
Barbara Davis Center
Aurora, Colorado, 80045, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Related Publications (1)
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.
PMID: 28700272DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Smita Barua, Clinical Trial Manager
- Organization
- Medtronic Diabtes
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald Brazg, M.D
Rainier Clinical Research Center
- PRINCIPAL INVESTIGATOR
Mark Christiansen, M.D
Diablo Clinical Research
- PRINCIPAL INVESTIGATOR
Timothy Bailey, M.D
AMCR Institute
- PRINCIPAL INVESTIGATOR
Satish Garg, M.D
Barbara Davis Center
- PRINCIPAL INVESTIGATOR
Robert Slover, M.D
Barbara Davis Center
- PRINCIPAL INVESTIGATOR
Bruce Bode, M.D
Atlanta Diabetes Associates
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2014
First Posted
September 23, 2014
Study Start
September 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
November 2, 2016
Results First Posted
November 2, 2016
Record last verified: 2016-10