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

NCT ID: NCT00805506

Last Updated: 2015-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-02-28

Study Completion Date

2007-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetes Insulin Treated

People with type 1 or type 2 diabetes on insulin.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International Diabetes Center at Park Nicollet

OTHER

Sponsor Role collaborator

LifeScan

INDUSTRY

Sponsor Role collaborator

HealthPartners Institute

OTHER

Sponsor Role lead

Responsible Party

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International Diabetes Center

Principal Investigators

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Roger S Mazze, PhD

Role: PRINCIPAL_INVESTIGATOR

International Diabetes Center at Park Nicollet

Elinor (Ellie) S Strock, APRN BC

Role: PRINCIPAL_INVESTIGATOR

International Diabetes Center at Park Nicollet

Locations

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International Diabetes Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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03349-05-A

Identifier Type: -

Identifier Source: org_study_id