Diabetes
Conditions
Keywords
continuous glucose monitoring accuracy
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.
Interventions
None listed
Sponsors
International Diabetes Center at Park Nicollet
LifeScan
HealthPartners Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed