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GLYCOSA Study:Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Royal North Shore Hospital
Baker IDI Heart and Diabetes Institute
International Diabetes Center at Park Nicollet
Information provided by (Responsible Party):
ResMed
ClinicalTrials.gov Identifier:
NCT00509223
First received: July 29, 2007
Last updated: December 4, 2013
Last verified: December 2013
History of Changes
Results First Received: August 8, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Mellitus Type 2
Interventions: Device: Positive Airway Pressure therapy
Behavioral: Lifestyle counseling

  Participant Flow
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  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.
118 subjects (of the 416 that started in the participant flow module) were not included in endpoint analysis due to reanalysis of OSA inclusion criteria. Thus, 298 of the 416 were included for final analysis.

Reporting Groups
  Description
Lifestyle Counseling With PAP Therapy No text entered.
Lifestyle Counseling No text entered.
Total Total of all reporting groups

Baseline Measures
   Lifestyle Counseling With PAP Therapy   Lifestyle Counseling   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 151   147   298 
Age 
[Units: Participants]
 		     
<=18 years   0   0   0 
Between 18 and 65 years   84   90   174 
>=65 years   67   57   124 
Age 
[Units: Years]
Mean (Standard Deviation) 		 62.4  (9.1)   62.1  (9.0)   62.3  (9.0) 
Gender 
[Units: Participants]
 		     
Female   52   54   106 
Male   99   93   192 
Region of Enrollment 
[Units: Participants]
 		     
United States   54   59   113 
Australia   97   88   185 


  Outcome Measures

1.  Primary:   HbA1c Change   [ Time Frame: Baseline to Month 6 ]
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  Serious Adverse Events
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  Other Adverse Events
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  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
No text entered.


  More Information
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