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Continuous Glucose Sensor Profiles in Non-Diabetic Subjects

NCT00717977 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2016-10-19

Study results available
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Summary

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.

Conditions

  • Healthy Subjects Without Type 1 Diabetes

Interventions

DEVICE

Continuous glucose monitor

Daily use of a continuous glucose monitor for 3-7 days

Sponsors & Collaborators

  • JDRF Artificial Pancreas Project

    collaborator NETWORK

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Roy W Beck, M.D., Ph.D. · Jaeb Center for Health Research

  • Lori Laffel, M.D. · Joslin Diabetes Center Pediatric Section

  • William Tamborlane, M.D. · Yale University

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2008-12-31
Completion
2009-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00717977 on ClinicalTrials.gov