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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00467675
Other study ID # 03403-06-C
Secondary ID
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
Est. primary completion date
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


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, 

See also
  Status Clinical Trial Phase
Completed NCT03028259 - Glucose Variability
Completed NCT04558710 - The Effect of Frequent Continuous Glucose Monitoring Use on Glucose Variability in Preschoolers With Type 1 Diabetes
Completed NCT00465881 - Develop Novel Methods to Display, Report and Analyze CGM Data for Clinical Decision-Making in People With Diabetes Phase 1
Recruiting NCT03804658 - The Factors Affecting the Achievement of Glucose Monitor in the Patients on Diabetes