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Establishing Ambulatory Glucose Profiles for People Without Diabetes Using CGM Data

This study has been completed.
Sponsor:
Collaborator:
Abbott Diabetes Care
Information provided by:
Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT00467675
First received: April 30, 2007
Last updated: December 5, 2007
Last verified: September 2007
  Purpose

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.


Condition Intervention Phase
NonDiabetes
Glucose Variability
CGM
Device: CGM System for Type 1 and Type 2 Diabetes Mellitus
Phase 2

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Park Nicollet Institute:

Enrollment: 35
Study Start Date: April 2006
Study Completion Date: January 2007
  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  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: NCT00467675

Locations
United States, Minnesota
International Diabetes Center - Park Nicollet Health Services
Minneapolis, Minnesota, United States, 55416
Sponsors and Collaborators
Park Nicollet Institute
Abbott Diabetes Care
Investigators
Principal Investigator: Roger S. Mazze, PhD International Diabetes Center - Park Nicollet Institute
Principal Investigator: Richard M. Bergenstal, MD International Diabetes Center - Park Nicollet Institute
Principal Investigator: Ellie S. Strock, RN BC-ANP International Diabetes Center - Park Nicollet Institute
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00467675     History of Changes
Other Study ID Numbers: 03403-06-C
Study First Received: April 30, 2007
Last Updated: December 5, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Park Nicollet Institute:
NonDiabetes
CGM

ClinicalTrials.gov processed this record on November 24, 2014