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OpenTrials
Completed

NCT Number: NCT00805506

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

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

Completed

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • International Diabetes Center at Park Nicollet
  • LifeScan

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 9, 2008
Registry last updated
Nov 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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