Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Comparing Self Monitored Blood Glucose (SMBG) to Continuous Glucose Monitoring (CGM) in Type 2 Diabetes (REACT3)

This study has been completed.
Sponsor:
Collaborators:
Roche Diagnostics Corporation
International Diabetes Center at Park Nicollet
Information provided by (Responsible Party):
Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT01237301
First received: November 2, 2010
Last updated: November 14, 2013
Last verified: November 2013
Results First Received: August 30, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Intervention: Device: Continuous Glucose Monitoring (CGM)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period October 29, 2010 through November 25, 2011. Study Location: Clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
CGM Group

Wear an unblinded CGM for 16 weeks.

Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes.

SMBG Group

Use SMBG 4 to 7 times a day for 16 weeks.

Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes.


Participant Flow:   Overall Study
    CGM Group     SMBG Group  
STARTED     65     59  
COMPLETED     60     55  
NOT COMPLETED     5     4  



  Baseline Characteristics
  Hide Baseline Characteristics

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
CGM Group

Wear an unblinded CGM for 16 weeks.

Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes.

SMBG Group

Use SMBG 4 to 7 times a day for 16 weeks.

Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes.

Total Total of all reporting groups

Baseline Measures
    CGM Group     SMBG Group     Total  
Number of Participants  
[units: participants]
  65     59     124  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     46     47     93  
>=65 years     19     12     31  
Age  
[units: years]
Mean ± Standard Deviation
  59.3  ± 8.9     58.8  ± 10     59  ± 0.9  
Gender  
[units: participants]
     
Female     29     32     61  
Male     36     27     63  
Region of Enrollment  
[units: participants]
     
United States     65     59     124  



  Outcome Measures

1.  Primary:   Percentage Change in Hemoglobin A1c   [ Time Frame: 2 week baseline to 18 week final ]

2.  Secondary:   The Secondary Objective is to Determine the Incremental Benefit of CGM for Clinical Decision-making.   [ Time Frame: 16 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Richard Bergenstal
Organization: International Diabetes Center
phone: 952-993-3796
e-mail: richard.bergenstal@parknicollet.com


Publications:

Responsible Party: Park Nicollet Institute
ClinicalTrials.gov Identifier: NCT01237301     History of Changes
Other Study ID Numbers: 04034-10-C
Study First Received: November 2, 2010
Results First Received: August 30, 2013
Last Updated: November 14, 2013
Health Authority: United States: Institutional Review Board