Evaluation of Glucose Monitoring Methods: Characterizing Glycemic Control in Subjects With Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- HealthPartners Institute
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A1c \>7.4 within last 4 months
- •type 1 or 2 diabetes treated with basal/bolus insulin
Exclusion Criteria
- •under 18 years of age
- •unable to read/write english
- •allergy to adhesives
- •employee of CGM company
Outcomes
Primary Outcomes
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.
Time Frame: 9 days