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Develop Novel Methods to Display, Report and Analyze CGM Data for Clinical Decision-Making in People With Diabetes

NCT ID: NCT00465881

Last Updated: 2015-12-03

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

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-04-30

Brief Summary

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The purpose of this study is to obtain sufficient continuous glucose monitoring (CGM) data in a manner that provides clinical information that is not available using conventional self-monitored blood glucose. Currently, a formal method does not exist for evaluating CGM data except for looking at each glucose reading across the days a CGM system has been worn and evaluating it based on clinical practice experience. The hope is that a mathematical model can be developed that will enable health care providers to quickly and easily determine what changes in diabetes treatment need to be made after CGM data is obtained.

Detailed Description

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There are two purposes to the study. First, to use an investigational device, the FreeStyle Navigator Continuous Glucose Monitoring (CGM) System (Abbott Diabetes Care) to obtain sufficient longitudinal data in order to develop a method for reporting CGM data in a manner that provides clinical information that is not available using conventional SMBG. The long-term goad is to determine the manner and degree to which CGM contributes to clinical decision-making. Because of the evidence that glucose regulation may be indirectly related to blood pressure levels, a second purpose of the study is to monitor variation in BP control by means of self-monitored BP.

Conditions

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Diabetes Glucose Variability CGM

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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CGM System for Type 1 and Type 2 Diabetes Mellitus

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female
* Diagnosed with type 1 or type 2 diabetes
* Treated with insulin therapy
* Can also be taking other diabetes medication treatment
* Age 21 and older
* Willing to give informed consent
* Capable of following the protocol and instructions of study staff
* Available for scheduled visits
* Access to telephone communications

Exclusion Criteria

* Under 21 years of age
* Unable to follow protocol
* Unable to read and write in English
* Skin abnormalities at insertion sites
* Allergy to adhesives
* Any concomitant medication thay would likely affect evaluation of device
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Diabetes Care

INDUSTRY

Sponsor Role collaborator

HealthPartners Institute

OTHER

Sponsor Role lead

Principal Investigators

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Roger S. Mazze, PhD

Role: PRINCIPAL_INVESTIGATOR

International Diabetes Center - Park Nicollet Institute

Richard M. Bergenstal, MD

Role: PRINCIPAL_INVESTIGATOR

International Diabetes Center - Park Nicollet Institute

Ellie S. Strock, RN BC-ANP

Role: PRINCIPAL_INVESTIGATOR

International Diabetes Center - Park Nicollet Institute

Locations

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International Diabetes Center - Park Nicollet Health Services

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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01929-05-C

Identifier Type: -

Identifier Source: org_study_id