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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
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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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 ]

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

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

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 ]

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 ]

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 ]

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 ]

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 ]

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

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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

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

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 ]

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 ]

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

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

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

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

24.  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 ]

25.  Secondary:   Quality of Life   [ Time Frame: 26 weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2009   Safety Issue:   No

26.  Secondary:   Cost-effectiveness of CGM   [ Time Frame: 26 weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2009   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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:
unchecked 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


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