Status:
COMPLETED
Establishing Ambulatory Glucose Profiles for People Without Diabetes Using CGM Data
Lead Sponsor:
HealthPartners Institute
Collaborating Sponsors:
Abbott Diabetes Care
Conditions:
NonDiabetes
Glucose Variability
Eligibility:
All Genders
21-75 years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00467675
Start Date
April 1 2006
End Date
January 1 2007
Last Update
December 3 2015
Active Locations (1)
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1
International Diabetes Center - Park Nicollet Health Services
Minneapolis, Minnesota, United States, 55416