Clinical trial NCT00467675: Establishing Ambulatory Glucose Profiles for People Without Diabetes Using CGM Data
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NonDiabetes
Glucose Variability
CGM
Keywords: NonDiabetes
CGM
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: Abbott Diabetes Care
First posted: 2007-05-01
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

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.


Eligibility 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: International Diabetes Center - Park Nicollet Health Services
state: Minnesota
Study officials:
affiliation: International Diabetes Center - Park Nicollet Institute
name: Roger S. Mazze, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Diabetes Center - Park Nicollet Institute
name: Richard M. Bergenstal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Diabetes Center - Park Nicollet Institute
name: Ellie S. Strock, RN BC-ANP
role: PRINCIPAL_INVESTIGATOR
affiliation: International Diabetes Center - Park Nicollet Institute
name: Johnson L. Mary, RN BS CDE
role: PRINCIPAL_INVESTIGATOR
affiliation: International Diabetes Center - Park Nicollet Institute
name: Margaret A. Powers, PhD RD CDE
role: PRINCIPAL_INVESTIGATOR
References: