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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00805506
• Other study ID #: 03349-05-A
• Status: Completed
• Phase: N/A
• First received: December 5, 2008
• Last updated: November 25, 2015
• Start date: February 2006
• Est. completion date: April 2007

Study information

• Verified date: December 2008
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
United States	International Diabetes Center	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
HealthPartners Institute	International Diabetes Center at Park Nicollet, LifeScan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No