Establishing Ambulatory Glucose Profiles for People Without Diabetes Using CGM Data

CGM Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00467675
• Other study ID #: 03403-06-C
• Status: Completed
• Phase: Phase 2
• First received: April 30, 2007
• Last updated: December 2, 2015
• Start date: April 2006
• Est. completion date: January 2007

Study information

• Verified date: September 2007
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• CGM
• Glucose Variability
• NonDiabetes

Intervention

Device:
• CGM System for Type 1 and Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
United States	International Diabetes Center - Park Nicollet Health Services	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
HealthPartners Institute	Abbott Diabetes Care

Country where clinical trial is conducted

United States,