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Clinical Trial NCT00939289 for Type 1 Diabetes Mellitus is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Concurrent Use of Two Continuous Glucose Monitoring Systems in Adults With Type 1 Diabetes Mellitus (T1DM) 14
Clinical Trial NCT00939289 was an observational study for Type 1 Diabetes Mellitus that is now completed. The study started on 1 July 2008, with plans to enroll 14 participants. Led by DexCom, Inc., the expected completion date was 1 February 2009. The latest data from ClinicalTrials.gov was last updated on 3 February 2010.
Brief Summary
The purpose of this pilot study is to evaluate performance of the SEVEN System and the Navigator System when both devices are worn concurrently by subjects with type 1 diabetes mellitus.
Official Title
Pilot Study of Concurrent Use of the SEVEN® and FreeStyle Navigator® Continuous Glucose Monitoring Systems in Adults With Type 1 Diabetes Mellitus
Conditions
Type 1 Diabetes MellitusPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- PTL-900070, Rev01
NCT ID Number
Start Date (Actual)
2008-07
Last Update Posted
2010-02-03
Completion Date (Estimated)
2009-02
Enrollment (Estimated)
14
Study Type
Observational
Status
Completed
Keywords
Continuous glucose monitoring
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Adults with T1DM Adults (18+ years-old) diagnosed with type 1 diabetes mellitus; treated with multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy | Continuous glucose monitoring Real-time continuous glucose monitoring with 2 commercially available Systems (DexCom SEVEN and Abbott Navigator) |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
CGM System(s) performance (relative to YSI and/or SMBG) evaluated by standard accuracy metrics | 15 days |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Documentation of all reported Adverse Device Effects, Serious Adverse Device Events, and Unanticipated Adverse Device Effects | 15 days |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Age 18 years or older;
- Have been diagnosed with type 1 diabetes and are on multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy;
- Willing not to inject insulin or wear an insulin pump infusion set within 3 inches from either Sensor site;
- Willing to participate in an 8-hour in-clinic session on study Days 5, 10, and 15 and be willing to take 4 fingersticks per hour and have 4 blood draws per hour for the 8-hour duration of each of these in-clinic sessions;
- Willing to take a minimum of 6 fingersticks per day during home use;
- Willing to refrain from the use of acetaminophen during this study and for at least 24-hours prior to enrollment;
- Willing not to schedule an magnetic resonance (MRI) scan, computed tomography (CT) scan, x-ray, for the duration of the study;
- Able to speak, read, and write English.
- Have extensive skin changes/diseases that preclude wearing the Sensor on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites;
- Subjects who have a known allergy to medical-grade adhesives;
- Are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion;
- Have a hematocrit that is less than 30%, or greater than 55%;
- Current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study);
- Have any condition that, in the opinion of the Investigator, would interfere with their participation in the trial or pose an excessive risk to study staff handling venous blood samples (e.g., known history of hepatitis B or C).
DexCom, Inc.No contact data.
1 Study Locations in 1 Countries
Colorado
Barbara Davis Center for Childhood Diabetes, Aurora, Colorado, 80045, United States