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  
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
  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.  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 ]

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 ]

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 ]

24.  Other Pre-specified:   26-week A1c Level <7.0% (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 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


  Other Adverse Events


  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.


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:
Other Publications:
Publications automatically indexed to this study:


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