Evaluation of Glucose Monitoring Methods: Characterizing Glycemic Control in Subjects With Diabetes
November 25, 2015 updated by: HealthPartners Institute
Evaluate the usefulness of continuous glucose monitoring devices in terms of their ability to identify periods throughout the day when glucose varies significantly.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
16
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55416
- International Diabetes Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
adults with diabetes who are treated with insulin
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Diabetes Insulin Treated
People with type 1 or type 2 diabetes on insulin.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
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9 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (Actual)
April 1, 2007
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
December 5, 2008
First Submitted That Met QC Criteria
December 8, 2008
First Posted (Estimate)
December 9, 2008
Study Record Updates
Last Update Posted (Estimate)
November 26, 2015
Last Update Submitted That Met QC Criteria
November 25, 2015
Last Verified
December 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03349-05-A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.