Continuous Glucose Sensor Profiles in Non-Diabetic Subjects

NCT00717977 | Completed Phase 4 Results DMC

• 1 other identifier: 2008-2403
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 10

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.

Conditions

Healthy Subjects Without Type 1 Diabetes

Outcome Measures

Primary Outcomes (25)

• Overall Mean Sensor Glucose by Age Group

  Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average over all 24 hours.

  48-72 hours

• Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group

  Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average from 6 a.m. to midnight.

  48-72 hours

• Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group

  Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average from midnight to 6 a.m.

  48-72 hours

• Peak Daytime Sensor Glucose Value by Age Group

  The calculation of peak and nadir glucose was restricted to days with \>=12 hours and nights with \>=4 hours of sensor glucose data.

  48-72 hours

• Peak Nightime Sensor Glucose Value by Age Group

  The calculation of peak and nadir glucose was restricted to days with \>=12 hours and nights with \>=4 hours of sensor glucose data.

  48-72 hours

• Daytime Nadir Sensor Glucose Value by Age Group

  The calculation of peak and nadir glucose was restricted to days with \>=12 hours and nights with \>=4 hours of sensor glucose data. The daytime nadir reflects the lowest point on the sensor glucose curve registered among daytime values.

  48-72 hours

• Nighttime Nadir Sensor Glucose Value by Age Group

  The calculation of peak and nadir glucose was restricted to days with \>=12 hours and nights with \>=4 hours of sensor glucose data. The nighttime nadir reflects the lowest point on the sensor glucose curve registered among nighttime values.

  48-72 hours

• Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group

  The Percentage Sensor Glucose Levels between 71-120 mg/dL was calculated for each subject. The median and quartiles over all subjects were reported here.

  48-72 hours

• Percentage of Sensor Glucose Levels 71-120 mg/dL by Time of Day

  48-72 hours

• Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group

  48-72 hours

• Percentage of Sensor Glucose Levels <=70 mg/dl by Time of Day

  48-72 hours

• Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group

  48-72 hours

• Percentage of Sensor Glucose Levels <=60 mg/dl by Time of Day

  The Percentage of Sensor Glucose Levels \<=60 mg/dl was calculated for each subject separately for the daytime and nighttime period. The median and quartiles over all subjects were reported. Here the data is different with data analyzed by age group, which is a subgroup analysis on 'percentage of sensor glucose levels \<=60mg/dL' for all 24 hours.

  48-72 hours

• Percentage of Sensor Glucose Levels >120 mg/dL by Age Group

  48-72 hours

• Percentage of Sensor Glucose Levels >120 mg/dl by Time of Day

  48-72 hours

• Percentage of Sensor Glucose Levels >140 mg/dL by Age Group

  48-72 hours

• Percentage of Sensor Glucose Levels >140 mg/dl by Time of Day

  The Percentage of Sensor Glucose Levels \>140 mg/dl was calculated for each subject separately for the daytime and nighttime period. The median and quartiles over all subjects were reported. Here the data is different with data analyzed by age group, which is a subgroup analysis on 'percentage of sensor glucose levels \>140 mg/dl' for all 24 hours.

  48-72 hours

• Glucose Variability Measure- Standard Deviation by Age Group

  Here, 'Standard Deviation' is a measure of glucose variability. This measure was calculated by taking the SD of all glucose values for each subject. Each subject has a SD value. The median and quartiles of this measure over all subjects were reported.

  48-72 hours

• Glucose Variability Measure- Standard Deviation by Time of Day

  Here, 'Standard Deviation' is a measure of glucose variability. This measure was calculated by taking the SD of all glucose values for each subject. Each subject has a SD value. The median and quartiles of this measure over all subjects were reported.

  48-72 hours

• Glucose Variability Measure- Absolute Rate of Change by Age Group

  48-72 hours

• Glucose Variability Measure- Absolute Rate of Change by Time of Day

  48-72 hours

• Glucose Variability Measure- Coefficient of Variation by Age Group

  The Coefficient of Variation is calculated by dividing the standard deviation by the mean glucose. Each subject received a SD value. The median and quartiles of this measure over all subjects were reported.

  48-72 hours

• Glucose Variability Measure- Coefficient of Variation by Time of Day

  The Coefficient of Variation is calculated by dividing the standard deviation by the mean glucose. Each subject received a SD value. The median and quartiles of this measure over all subjects were reported.

  48-72 hours

• Glucose Variability Measure: Mean Amplitude of Glycemic Excursions by Age Group

  The Mean Amplitude of Glycemic Excursions also known as MAGE depicts the upward and downward acute glucose fluctuations seen in the sensor data.

  48-72 hours

• Glucose Variability Measure: Amplitude of Glycemic Excursions by Time of Day

  The Mean Amplitude of Glycemic Excursions also known as MAGE depicts the upward and downward acute glucose fluctuations seen in the sensor data.

  48-72 hours

Interventions

Continuous glucose monitor DEVICE

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

Also known as: Abbott FreeStyle Navigator, DexCom SEVEN, Medtronic Guardian Clinical

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• JDRF Artificial Pancreas Project: collaborator

Study Sites (10)

Kaiser Permanente

San Diego, California, 92111, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30309, United States

Location

Children's Hospital of Iowa

Iowa City, Iowa, 52242, United States

Location

Joslin Diabetes Center - Adults

Boston, Massachusetts, 02215, United States

Location

Joslin Diabetes Center - Children

Boston, Massachusetts, 02215, United States

Location

University of Washington

Seattle, Washington, 98105, United States

Location

Related Publications (2)

• 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.

  PMID: 20215454 RESULT

• 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.

  PMID: 36790875 DERIVED

Results Point of Contact

• Title: Roy W. Beck, M.D., Ph.D.
• Organization: Jaeb Center for Health Research

rbeck@jaeb.org

813-975-8690

Study Officials

• Roy W Beck, M.D., Ph.D.

  Jaeb Center for Health Research

  STUDY DIRECTOR

• Lori Laffel, M.D.

  Joslin Diabetes Center Pediatric Section

  STUDY CHAIR

• William Tamborlane, M.D.

  Yale University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2008
• First Posted: July 18, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: March 1, 2009
• Last Updated: October 19, 2016
• Results First Posted: October 18, 2010

Record last verified: 2016-09

Locations

US (10)