Continuous Glucose Sensor Profiles in Non-Diabetic Subjects

NCT ID: NCT00717977

Last Updated: 2016-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-03-31

Brief 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.

Detailed Description

1. After initial eligibility is determined, informed consent and assent are obtained from the parent/guardian and subject.

2. Subjects will have the following tests performed:

• Hemoglobin A1c (using the DCA2000 or equivalent device)
• Oral glucose tolerance test to obtain fasting and 2 hour plasma glucose levels
• Anti-GAD, anti-IA2 and anti-insulin antibodies

• Subjects with an HbA1c >6.0% and/or fasting glucose levels >100 and/or 2 hour glucose levels >140 will be discontinued from the study.

3. Subjects with normal A1c and glucose levels will be provided with an RT-CGM and home glucose meter (HGM)

4. An RT-CGM sensor will be inserted and initiated by study personnel.

5. Subjects who would like to wear 2 sensors will be given 2 of the same type of RT-CGM.

6. Subjects will be instructed to wear the sensor for 3-7 days (depending on the type of device) and measure the blood glucose on the HGM as needed to calibrate the sensor.

7. Subjects will return to the clinical center after the 3-7 days of sensor wear to return the RT-CGM and HGM.

• If the subject has less than 48 hours of sensor data he or she will be asked to wear another sensor and return 3-7 days later.

Conditions

Healthy Subjects Without Type 1 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

Continuous glucose monitor

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

Intervention Type: DEVICE

Other Intervention Names

Abbott FreeStyle Navigator; DexCom SEVEN; Medtronic Guardian Clinical

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• History of diabetes or positive islet cell antibody testing

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

JDRF Artificial Pancreas Project

NETWORK

Sponsor Role: collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roy W Beck, M.D., Ph.D.

Role: STUDY_DIRECTOR

Jaeb Center for Health Research

Lori Laffel, M.D.

Role: STUDY_CHAIR

Joslin Diabetes Center Pediatric Section

William Tamborlane, M.D.

Role: STUDY_CHAIR

Yale University

Locations

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

Countries

United States

References

Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Fox LA, Beck RW, Xing D. Variation of interstitial glucose measurements assessed by continuous glucose monitors in healthy, nondiabetic individuals. Diabetes Care. 2010 Jun;33(6):1297-9. doi: 10.2337/dc09-1971. Epub 2010 Mar 9.

Reference Type: RESULT

PMID: 20215454 (View on PubMed)

Shah VN, Vigers T, Pyle L, Calhoun P, Bergenstal RM. Discordance Between Glucose Management Indicator and Glycated Hemoglobin in People Without Diabetes. Diabetes Technol Ther. 2023 May;25(5):324-328. doi: 10.1089/dia.2022.0544. Epub 2023 Mar 3.

Reference Type: DERIVED

PMID: 36790875 (View on PubMed)

Other Identifiers

2008-2403

Identifier Type: -

Identifier Source: org_study_id