Randomized Study of Real-Time Continuous Glucose Monitors (RT-CGM) in the Management of Type 1 Diabetes

NCT00406133 | Completed Phase 3 Results DMC

• 1 other identifier: 2006-2402
• Study Type: interventional
• Target: 451
• Locations: 1 country
• Sites: 11

Brief Summary

Subjects with intensively-treated type 1 diabetes and glycated hemoglobin (HbA1c) 7.0%-10.0% in 3 age groups (\>25, 15-24, 8-14) will be randomized to a continuous glucose monitoring (CGM) group or control group. The primary outcome is change in HbA1c after 26 weeks. A parallel randomized trial is being conducted for a second cohort with HbA1c \<7.0% that will follow an identical protocol to that of the first cohort with HbA1c \>=7.0%. The \>=7.0% trial was specifically designed and statistically powered to compare separately the impact of continuous versus standard intensive glucose monitoring in the three age groups. Both trials used standardized treatment algorithms and equivalent frequent contacts with subjects in both the CGM and control group. After completion of the 26-week trial, the CGM group continues to use CGM for another 26 weeks to evaluate whether any beneficial effect seen in the first 6 months is sustained with longer-term use and less intensive contact and the control group initiates CGM use with less intensive contact after the first month than was provided at initiation of CGM use in the CGM group in the randomized trial.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

• Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c >=7.0% Cohort)

  The primary outcome was the Change in glycated hemoglobin (HbA1c) from baseline to 26 weeks, as determined by a central laboratory (for the cohort with baseline HbA1c \>=7.0% cohort).

  Baseline and 26 weeks

• Time With Glucose Level <=70 mg/dL (for the Cohort With Baseline HbA1c <7.0%)

  The primary outcome was the change in the time per day with glucose values \<=70mg/dL comparing baseline sensor values with those obtained following the 26-week visit.

  Baseline and 26 weeks

Secondary Outcomes (17)

• Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort)

  Baseline and 26 weeks

• Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)

  Baseline and 26 weeks

• Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)

  Baseline and 26 weeks

• Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort

  Baseline and 26 weeks

• Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%)

  Baseline and 26 weeks

Other Outcomes (8)

• Relative Decrease in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)

  Baseline and 26 weeks

• Relative Increase in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)

  Baseline and 26 weeks

• Relative Decrease in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)

  Baseline and 26 weeks

Study Arms (2)

Standard intensive glucose monitoring

NO INTERVENTION

Patients in the control group were given blood glucose meters and test strips and asked to perform home blood glucose monitoring at least four times daily.

Continuous Glucose Monitoring (CGM)

ACTIVE COMPARATOR

Patients in the CGM group were instructed to use the CGM device on a daily basis and to verify the accuracy of the glucose measurement with a home blood glucose meter (provided by the study) before making management decisions (as per the regulatory labeling of the devices).

Device: Continuous glucose monitor

Interventions

Continuous glucose monitor DEVICE

Daily use of a continuous glucose monitor

Also known as: Abbott FreeStyle Navigator, DexCom SEVEN, Medtronic Paradigm REAL-Time

Continuous Glucose Monitoring (CGM)

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year
• The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
• Age \>8 years
• Glycated hemoglobin(HbA1c) 7.0%-10.0% for the primary cohort and \<7.0% for the secondary cohort
• The DCA2000 or comparable point of care device will be used to assess eligibility.
• Insulin regimen involves either use of an insulin pump or multiple daily injections of insulin (at least 3 shots per day) and has been stable for the last two months, with no plans to switch the modality of insulin administration during the next 6 months (e.g., injection user switching to a pump, pump user switching to injections, or the addition of Lantus (Glargine) insulin)
• Subjects using premixed fixed doses of insulin at the time of enrollment will not be eligible
• Subject (and parent/guardian for children) understands the study protocol and agrees to comply with it
• Subjects \>9 years old and primary care giver (i.e., parent or guardian if subject is a minor) comprehend written English or Spanish
• This requirement is due to the fact that the questionnaires to be used as outcome measures do not have validated versions in other languages.
• Spanish-speaking subjects will be enrolled only if a RT-CGM device that functions in Spanish and has a User Guide in Spanish is available.
• No expectation that subject will be moving out of the area of the clinical center during the next year, unless the move will be to an area served by another study center.
• Informed Consent Form signed by the subject (or parent/guardian if subject is a minor, with subject signing the Child Assent Form)

You may not qualify if:

• The presence of a significant medical disorder or use of a medication such as oral/inhaled glucocorticoids that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
• The presence of any of the following diseases:
• Asthma if treated with systemic or inhaled corticosteroids in the last 6 months
• Cystic fibrosis
• Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
• Inpatient psychiatric treatment in the past 6 months (if the subject is a minor, for either the subject or the subject's primary care giver).
• Home use of RT-CGM in past 6 months
• Use of a CGMS or GlucoWatch does not exclude subjects from enrollment
• Participation in an intervention study (including psychological studies) in past 6 weeks.
• Another member of the same household is participating in this study.

Sponsors & Collaborators

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

Study Sites (11)

University of Southern California

Beverly Hills, California, 90211, United States

Location

Kaiser Permanente

San Diego, California, 92111, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Colorado

Aurora, Colorado, 80010, 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 (11)

• JDRF CGM Study Group. JDRF randomized clinical trial to assess the efficacy of real-time continuous glucose monitoring in the management of type 1 diabetes: research design and methods. Diabetes Technol Ther. 2008 Aug;10(4):310-21. doi: 10.1089/dia.2007.0302.

  PMID: 18828243 BACKGROUND

• Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Tamborlane WV, Beck RW, Bode BW, Buckingham B, Chase HP, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Hirsch IB, Huang ES, Kollman C, Kowalski AJ, Laffel L, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer S, Wilson DM, Wolpert H, Wysocki T, Xing D. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008 Oct 2;359(14):1464-76. doi: 10.1056/NEJMoa0805017. Epub 2008 Sep 8.

  PMID: 18779236 RESULT

• Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Beck RW, Hirsch IB, Laffel L, Tamborlane WV, Bode BW, Buckingham B, Chase P, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Huang ES, Kollman C, Kowalski AJ, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer SA, Wilson DM, Wolpert H, Wysocki T, Xing D. The effect of continuous glucose monitoring in well-controlled type 1 diabetes. Diabetes Care. 2009 Aug;32(8):1378-83. doi: 10.2337/dc09-0108. Epub 2009 May 8.

  PMID: 19429875 RESULT

• Wilson DM, Xing D, Cheng J, Beck RW, Hirsch I, Kollman C, Laffel L, Lawrence JM, Mauras N, Ruedy KJ, Tsalikian E, Wolpert H; Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Persistence of individual variations in glycated hemoglobin: analysis of data from the Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Randomized Trial. Diabetes Care. 2011 Jun;34(6):1315-7. doi: 10.2337/dc10-1661. Epub 2011 Apr 19.

  PMID: 21505208 DERIVED

• Xing D, Kollman C, Beck RW, Tamborlane WV, Laffel L, Buckingham BA, Wilson DM, Weinzimer S, Fiallo-Scharer R, Ruedy KJ; Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Optimal sampling intervals to assess long-term glycemic control using continuous glucose monitoring. Diabetes Technol Ther. 2011 Mar;13(3):351-8. doi: 10.1089/dia.2010.0156. Epub 2011 Feb 7.

  PMID: 21299401 DERIVED

• Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Fiallo-Scharer R, Cheng J, Beck RW, Buckingham BA, Chase HP, Kollman C, Laffel L, Lawrence JM, Mauras N, Tamborlane WV, Wilson DM, Wolpert H. Factors predictive of severe hypoglycemia in type 1 diabetes: analysis from the Juvenile Diabetes Research Foundation continuous glucose monitoring randomized control trial dataset. Diabetes Care. 2011 Mar;34(3):586-90. doi: 10.2337/dc10-1111. Epub 2011 Jan 25.

  PMID: 21266651 DERIVED

• Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Wilson DM, Xing D, Beck RW, Block J, Bode B, Fox LA, Hirsch I, Kollman C, Laffel L, Ruedy KJ, Steffes M, Tamborlane WV. Hemoglobin A1c and mean glucose in patients with type 1 diabetes: analysis of data from the Juvenile Diabetes Research Foundation continuous glucose monitoring randomized trial. Diabetes Care. 2011 Mar;34(3):540-4. doi: 10.2337/dc10-1054. Epub 2011 Jan 25.

  PMID: 21266647 DERIVED

• Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Prolonged nocturnal hypoglycemia is common during 12 months of continuous glucose monitoring in children and adults with type 1 diabetes. Diabetes Care. 2010 May;33(5):1004-8. doi: 10.2337/dc09-2081. Epub 2010 Mar 3.

  PMID: 20200306 DERIVED

• Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Effectiveness of continuous glucose monitoring in a clinical care environment: evidence from the Juvenile Diabetes Research Foundation continuous glucose monitoring (JDRF-CGM) trial. Diabetes Care. 2010 Jan;33(1):17-22. doi: 10.2337/dc09-1502. Epub 2009 Oct 16.

  PMID: 19837791 DERIVED

• Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Beck RW, Buckingham B, Miller K, Wolpert H, Xing D, Block JM, Chase HP, Hirsch I, Kollman C, Laffel L, Lawrence JM, Milaszewski K, Ruedy KJ, Tamborlane WV. Factors predictive of use and of benefit from continuous glucose monitoring in type 1 diabetes. Diabetes Care. 2009 Nov;32(11):1947-53. doi: 10.2337/dc09-0889. Epub 2009 Aug 12.

  PMID: 19675206 DERIVED

• Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Bode B, Beck RW, Xing D, Gilliam L, Hirsch I, Kollman C, Laffel L, Ruedy KJ, Tamborlane WV, Weinzimer S, Wolpert H. Sustained benefit of continuous glucose monitoring on A1C, glucose profiles, and hypoglycemia in adults with type 1 diabetes. Diabetes Care. 2009 Nov;32(11):2047-9. doi: 10.2337/dc09-0846. Epub 2009 Aug 12.

  PMID: 19675193 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

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

rbeck@jaeb.org

813-975-8690

Study Officials

• Roy W Beck, MD, PhD

  Jaeb Center for Health Research

  STUDY DIRECTOR

• Lori Laffel, MD

  Joslin Diabetes Center Pediatric Section

  STUDY CHAIR

• William V. Tamborlane, MD

  Yale University

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2006
• First Posted: December 4, 2006
• Study Start: December 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: February 1, 2009
• Last Updated: April 14, 2017
• Results First Posted: September 2, 2009

Record last verified: 2017-03

Locations

US (11)