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Evaluation of Glucose Monitoring Methods: Characterizing Glycemic Control in Subjects With Diabetes

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HealthPartners Institute

Status

Completed

Conditions

Diabetes

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT00805506
03349-05-A

Details and patient eligibility

About

Evaluate the usefulness of continuous glucose monitoring devices in terms of their ability to identify periods throughout the day when glucose varies significantly.

Full 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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

16 participants in 1 patient group

Diabetes Insulin Treated
Description:
People with type 1 or type 2 diabetes on insulin.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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