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

This study has been completed.

Sponsor:

Information provided by:

JDRF Artificial Pancreas Project

ClinicalTrials.gov Identifier:

NCT00406133

First received: November 30, 2006

Last updated: September 30, 2010

Last verified: September 2010

History of Changes

Results First Received: May 11, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Outcomes Assessor); Primary Purpose: Treatment
Condition:	Type 1 Diabetes
Intervention:	Device: Continuous glucose monitor

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from within the patient population of the study clinical centers.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants completed a run-in phase wearing a blinded continuous glucose monitoring (CGM) device. Eligibility required that a sensor be worn for six out of seven days prior to randomization, with a minimum of 96 hours of glucose values with at least 24 hours overnight, and home blood glucose monitoring be performed at least three times daily.

Reporting Groups

	Description
Primary Cohort RT-CGM Group	Participants with baseline A1c >=7.0% who were randomized to CGM use
Primary Cohort Control Group	Participants with baseline A1c >=7.0% who were randomized to standard care
Secondary Cohort RT-CGM Group	Participants with baseline A1c <7.0% who were randomized to CGM use
Secondary Cohort Control Group	Participants with baseline A1c <7.0% who were randomized to standard care

Participant Flow for 2 periods

Period 1: Phase 1 (First 26 Week Period)

	Primary Cohort RT-CGM Group	Primary Cohort Control Group	Secondary Cohort RT-CGM Group	Secondary Cohort Control Group
STARTED	165	157	67	62
COMPLETED	162	155	67	60
NOT COMPLETED	3	2	0	2

Period 2: Phase 2 (Second 26 Week Period)

	Primary Cohort RT-CGM Group	Primary Cohort Control Group	Secondary Cohort RT-CGM Group	Secondary Cohort Control Group
STARTED	159 ^[1]	155	67	60
COMPLETED	157	152	67	60
NOT COMPLETED	2	3	0	0

[1]	3 subjects completed phase 1 but elected not to go into phase 2.

Baseline Characteristics

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Reporting Groups

	Description
Primary Cohort RT-CGM Group	Participants with baseline A1c >=7.0% who were randomized to CGM use
Primary Cohort Control Group	Participants with baseline A1c >=7.0% who were randomized to standard care
Secondary Cohort RT-CGM Group	Participants with baseline A1c <7.0% who were randomized to CGM use
Secondary Cohort Control Group	Participants with baseline A1c <7.0% who were randomized to standard care
Total	Total of all reporting groups

Baseline Measures

	Primary Cohort RT-CGM Group	Primary Cohort Control Group	Secondary Cohort RT-CGM Group	Secondary Cohort Control Group	Total
Number of Participants [units: participants]	165	157	67	62	451
Age, Customized [units: participants]
8-14 years	56	58	18	11	143
15-24 years	57	53	15	18	143
>=25 years	52	46	34	33	165
Gender [units: participants]
Female	87	93	36	32	248
Male	78	64	31	30	203
Race/Ethnicity, Customized [units: participants]
Non-Hispanic White	150	146	63	58	417
Other	15	11	4	4	34
College graduate (subject or primary care giver) [units: participants]
College graduate	125	125	58	55	363
Other	40	32	9	7	88
Insulin modality [units: participants]
Pump	128	128	62	49	367
Multiple daily injections	37	29	5	13	84
One or more severe hypoglycemic events in last six months [units: participants]
One or more events	14	10	7	7	38
No events	151	147	60	55	413
Duration of diabetes [units: years] Mean ± Standard Deviation
8-14 years	6.2 ± 3.1	5.3 ± 2.8	4.9 ± 2.6	4.4 ± 3.2	5.5 ± 3.0
15-24 years	9.5 ± 4.8	8.8 ± 4.0	8.7 ± 5.3	8.1 ± 4.5	9.0 ± 4.5
>=25 years	23.6 ± 10.6	21.8 ± 10.4	25.6 ± 16.6	28.6 ± 12.7	24.5 ± 12.6
Glycated hemoglobin (HbA1c) [units: percent] Mean ± Standard Deviation	7.9 ± 0.7	7.8 ± 0.7	6.4 ± 0.5	6.5 ± 0.3	7.4 ± 0.9

Outcome Measures

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1. Primary:

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) [ Time Frame: Baseline and 26 weeks ]

Show Outcome Measure 1

2. Primary:

Time With Glucose Level <=70 mg/dL (for the Cohort With Baseline HbA1c <7.0%) [ Time Frame: Baseline and 26 weeks ]

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3. Secondary:

Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort) [ Time Frame: Baseline and 26 weeks ]

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4. Secondary:

Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) [ Time Frame: Baseline and 26 weeks ]

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5. Secondary:

Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) [ Time Frame: Baseline and 26 weeks ]

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6. Secondary:

Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort [ Time Frame: Baseline and 26 weeks ]

Show Outcome Measure 6

7. Secondary:

Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%) [ Time Frame: Baseline and 26 weeks ]

Show Outcome Measure 7

8. Secondary:

Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%) [ Time Frame: Baseline and 26 weeks ]

Show Outcome Measure 8

9. Secondary:

Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%) [ Time Frame: Baseline and 26 weeks ]

Show Outcome Measure 9

10. Secondary:

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) [ Time Frame: Baseline and 26 weeks ]

Show Outcome Measure 10

11. Secondary:

Minutes Per Day of Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for Cohort With Baseline HbA1c <7.0%) [ Time Frame: Baseline and 26 weeks ]

Show Outcome Measure 11

12. Secondary:

Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for Cohort With Baseline HbA1c <7.0%) [ Time Frame: Baseline and 26 weeks ]

Show Outcome Measure 12

13. Secondary:

Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c <7.0% Cohort [ Time Frame: Baseline and 26 weeks ]

Show Outcome Measure 13

14. Secondary:

Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c <7.0%) [ Time Frame: Baseline and 26 weeks ]

Show Outcome Measure 14

15. Secondary:

Absolute Rate of Change (mg/dl/Min) at 26 Weeks (for Cohort With Baseline HbA1c <7.0%) [ Time Frame: Baseline and 26 weeks ]

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16. Other Pre-specified:

Relative Decrease in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%) [ Time Frame: Baseline and 26 weeks ]

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17. Other Pre-specified:

Relative Increase in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%) [ Time Frame: Baseline and 26 weeks ]

Show Outcome Measure 17

18. Other Pre-specified:

Relative Decrease in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%) [ Time Frame: Baseline and 26 weeks ]

Show Outcome Measure 18

19. Other Pre-specified:

Relative Increase in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%) [ Time Frame: Baseline and 26 weeks ]

Show Outcome Measure 19

20. Other Pre-specified:

26-week A1c Level <7.0% (for Cohort With Baseline HbA1c >=7.0%) [ Time Frame: Baseline and 26 weeks ]

Show Outcome Measure 20

21. Post-Hoc:

26-week A1c Level <7.0%, With no Severe Hypoglycemic Events for Cohort With Baseline HbA1c >=7.0%) [ Time Frame: Baseline and 26 weeks ]

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22. Other Pre-specified:

Decrease in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%) [ Time Frame: Baseline and 26 weeks ]

Show Outcome Measure 22

23. Other Pre-specified:

Increase in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%) [ Time Frame: Baseline and 26 weeks ]

Show Outcome Measure 23

24. Other Pre-specified:

26-week A1c Level <7.0% (for Cohort With Baseline HbA1c <7.0%) [ Time Frame: Baseline and 26 weeks ]

Show Outcome Measure 24

25. Secondary:

Quality of Life [ Time Frame: 26 weeks ]

Results not yet posted. Anticipated Posting Date: 12/2009 Safety Issue: No

26. Secondary:

Cost-effectiveness of CGM [ Time Frame: 26 weeks ]

Results not yet posted. Anticipated Posting Date: 12/2009 Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Roy W. Beck, M.D., Ph.D., Director
Organization: Jaeb Center for Health Research
phone: 813-975-8690
e-mail: rbeck@jaeb.org

Publications of Results:

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. Epub 2008 Sep 8.

Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. The effect of continuous glucose monitoring in well-controlled type 1 diabetes. Diabetes Care. 2009 Aug;32(8):1378-83. Epub 2009 May 8.

Other Publications:

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.

Publications automatically indexed to this study:

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. Epub 2011 Apr 19.

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. Epub 2011 Feb 7.

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. Epub 2011 Jan 25.

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. Epub 2011 Jan 25.

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. Epub 2010 Mar 3.

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. Epub 2009 Oct 16.

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. Epub 2009 Aug 12.

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. Epub 2009 Aug 12.

Responsible Party:	Roy W. Beck, Jaeb Center for Health Research
ClinicalTrials.gov Identifier:	NCT00406133 History of Changes
Other Study ID Numbers:	2006-2402
Study First Received:	November 30, 2006
Results First Received:	May 11, 2009
Last Updated:	September 30, 2010
Health Authority:	United States: Food and Drug Administration

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