Evaluation of Glucose Monitoring Methods: Characterizing Glycemic Control in Subjects With Diabetes
- Conditions
- Diabetes
- Registration Number
- NCT00805506
- Lead Sponsor
- HealthPartners Institute
- Brief Summary
Evaluate the usefulness of continuous glucose monitoring devices in terms of their ability to identify periods throughout the day when glucose varies significantly.
- Detailed Description
Many CGM systems use a surrogate for blood glucose--tissue glucose or interstitial glucose. Interstitial fluid (ISF) is the medium for these approaches. A physiological lag in ISF glucose relative to capillary blood glucose has been noted, probably due to relatively low blood perfusion at the sampling site. 9 This physiological lag can result in an accuracy error, manifesting as a significant bias between blood and tissue glucose, particularly during periods of rapid glucose change. This lag error might be particularly meaningful when glucose is rapidly dropping towards hypoglycemia.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- adult
- A1c >7.4 within last 4 months
- type 1 or 2 diabetes treated with basal/bolus insulin
- under 18 years of age
- unable to read/write english
- allergy to adhesives
- employee of CGM company
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To collect sufficient glucose data by means of continuous glucose monitoring for the purpose of detecting clinically relevant alterations in blood glucose throughout a typical or modal day. 9 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
International Diabetes Center
🇺🇸Minneapolis, Minnesota, United States