Study Stopped
Business Decision
A Performance Evaluation of the Enlite 3 Sensor
1 other identifier
interventional
N/A
1 country
2
Brief Summary
The purpose of this study is to support the use of the Enlite 3 sensor in arm and thigh in subjects age 14 - 75 years and provide additional characterization of the Enlite 3 sensor performance in arm in subjects age 14 - 75 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2016
Shorter than P25 for not_applicable
2 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
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 4, 2016
CompletedFirst Posted
Study publicly available on registry
January 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJune 23, 2016
June 1, 2016
4 months
January 4, 2016
June 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Enlite 3 Sensor inserted at Arm accuracy using a real time device: (640G pump) with the minimum calibration requirements (every 12 hours after the second calibration) will be evaluated.
Glucose sensor values will be compared to Yellow Spring Instruments (YSI)plasma glucose values during Frequent Sample Testing.
1 month
Study Arms (2)
Group A
ACTIVE COMPARATORSubjects will be randomly assigned to 2 groups (Group A \& Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.
Group B
ACTIVE COMPARATORSubjects will be randomly assigned to 2 groups (Group A \& Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.
Interventions
Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the arm and used with the 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least 12 months.
Eligibility Criteria
You may qualify if:
- Subject is 14 - 75 years of age at time of screening.
- A clinical diagnosis of type 1 or 2 diabetes for a minimum of 9 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 Enlite 3 Sensors or device placement (e.g., psoriasis, rash, Staphylococcus infection)
- 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
- 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 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 (2)
Diablo Clinical Research
Walnut Creek, California, 94598, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Scott Lee, MD
Medtronic Diabetes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2016
First Posted
January 7, 2016
Study Start
January 1, 2016
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
June 23, 2016
Record last verified: 2016-06