Establishing Ambulatory Glucose Profiles for People Without Diabetes Using CGM Data

December 2, 2015 updated by: HealthPartners Institute

Observational Study of Interstitial Glucose Monitoring With the FreeStyle Navigator CGM System to Develop Novel Methods for Displaying, Reporting and Analyzing CGM Data for Clinical Decision-Making: Phase 2-Establishing Ambulatory Glucose Profiles for Individuals Without Diabetes

In a previous study we used the FreeStyle Navigator Continuous Glucose Monitoring (CGM) System to obtain 30 days of glucose measurements from 30 people with diabetes treated with insulin. The purpose of this study is to characterize glycemia (glucose) control in 30 people without diabetes and to compare these data to the 30 people with diabetes from a previous study. Through this approach it may be possible to develop a means of establishing a model of normal glucose patterns and a basis of comparison with glucose patterns in people with diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

35

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

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • International Diabetes Center - Park Nicollet Health Services

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

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female
  • Within normal range for two hour OGTT glucose level (<140 mg/dl)
  • Within normal range for fasting glucose level (<100 mg/dl)
  • Within normal range for total insulin level as measured by radioimmunoassay
  • BMI <30kg/m2
  • Age 21-75 years of age, inclusive (15 subjects in the 21-49 years of age group, 15 subjects in the 50-75 years of age group)
  • 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 or over 75 years of age
  • Abnormal OGTT
  • Previous history of diabetes
  • Outside of normal insulin range
  • BMI > 30kg/m2
  • Unable to follow protocol
  • Unable to read and write in English
  • Skin abnormalities at insertion sites
  • Allergy to adhesives
  • Any concomitant medical condition that would likely affect the evaluation of device performance
  • Taken prednisone or cortisone medications in the previous 30 days
  • Blood transfusion within the past 90 days
  • Blood donation within the past 30 days
  • Metabolic syndrome (NCEP ATP III guidelines)
  • Any medical condition that would affect glucose (per investigator decision)

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Collaborators

Abbott Diabetes Care

Investigators

  • Principal Investigator: Johnson L. Mary, RN BS CDE, International Diabetes Center - Park Nicollet Institute
  • Principal Investigator: Margaret A. Powers, PhD RD CDE, International Diabetes Center - Park Nicollet Institute

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

April 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

April 30, 2007

First Submitted That Met QC Criteria

April 30, 2007

First Posted (Estimate)

May 1, 2007

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 03403-06-C

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.

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