Continuous Glucose Sensor Profiles in Non-Diabetic Subjects

Completed · Phase 4

Conditions studied: Healthy Subjects Without Type 1 Diabetes

In brief

The Juvenile Diabetes Research Foundation (JDRF) Glucose Sensor Study group is carrying out a large, randomized clinical trial to assess the efficacy, safety and cost-effectiveness of use of real-time continuous glucose monitors (RT-CGM) as an adjunct to standard meter plasma glucose testing. Although the primary outcome in the \>= 7.0% cohort is differences in HbA1c levels, important secondary outcomes are differences in the percent of glucose sensor values either above or below the target glucose range of 70-180 mg/dl and differences in glucose variability. Prevention of biochemical hypoglycemia is a particularly important outcome in the low HbA1c cohort. Since CGM systems measure interstitial rather than plasma glucose and CGM values differ from simultaneous plasma glucose values by up to 18%, it would be extremely useful for comparative purposes to establish a reference range of sensor values in healthy, non-diabetic control subjects for this study and other future investigations. The objective of this protocol is to establish such reference sensor glucose ranges in each of the 3 devices being utilized in the JDRF study.

Key facts

Study ID

NCT00717977

Run by

Jaeb Center for Health Research

People needed

74

Starts

2008-07-01

Expected to finish

2009-03-01

Last updated by the study team

2016-10-19

Who can join

Age: 8 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age > 8 years
• Body mass index (BMI) between the 10th to 90th percentile for age and sex (based on CDC, 2000 nomogram) and < 28 kg body weight/meter in adult subjects
• No significant chronic illness or taking any acute or chronic medications that might affect glucose metabolism.

You may not qualify if…

• History of diabetes or positive islet cell antibody testing

Where it is running

• Kaiser Permanente — San Diego, California, United States
• Stanford University — Stanford, California, United States
• University of Colorado — Aurora, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• Atlanta Diabetes Associates — Atlanta, Georgia, United States
• Children's Hospital of Iowa — Iowa City, Iowa, United States
• Joslin Diabetes Center - Adults — Boston, Massachusetts, United States
• Joslin Diabetes Center - Children — Boston, Massachusetts, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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