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

This study has been completed.
Sponsor:
Collaborators:
International Diabetes Center at Park Nicollet
LifeScan
Information provided by:
Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT00805506
First received: December 5, 2008
Last updated: December 8, 2008
Last verified: December 2008
  Purpose

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


Condition
Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Glucose Monitoring Methods: Characterizing Glycemic Control in Subjects With Diabetes

Resource links provided by NLM:


Further study details as provided by Park Nicollet Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: February 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diabetes Insulin Treated
People with type 1 or type 2 diabetes on insulin.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

adults with diabetes who are treated with insulin

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805506

Locations
United States, Minnesota
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
Sponsors and Collaborators
Park Nicollet Institute
International Diabetes Center at Park Nicollet
LifeScan
Investigators
Principal Investigator: Roger S Mazze, PhD International Diabetes Center at Park Nicollet
Principal Investigator: Elinor (Ellie) S Strock, APRN BC International Diabetes Center at Park Nicollet
  More Information

No publications provided

Responsible Party: Roger S. Mazze, PhD, International Diabetes Center
ClinicalTrials.gov Identifier: NCT00805506     History of Changes
Other Study ID Numbers: 03349-05-A
Study First Received: December 5, 2008
Last Updated: December 8, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Park Nicollet Institute:
continuous glucose monitoring accuracy

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014