Establishing Ambulatory Glucose Profiles for People Without Diabetes Using CGM Data

NCT00467675 | Completed

• 1 other identifier: 03403-06-C
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NonDiabetes; Glucose Variability; CGM

Keywords

NonDiabetes; CGM

Interventions

CGM System for Type 1 and Type 2 Diabetes Mellitus DEVICE

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• HealthPartners Institute: lead
• Abbott Diabetes Care: collaborator

Study Sites (1)

International Diabetes Center - Park Nicollet Health Services

Minneapolis, Minnesota, 55416, United States

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 30, 2007
• First Posted: May 1, 2007
• Study Start: April 1, 2006
• Study Completion: January 1, 2007
• Last Updated: December 3, 2015

Record last verified: 2007-09

Locations

US (1)