Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Royal North Shore Hospital
Baker IDI Heart and Diabetes Institute
International Diabetes Center at Park Nicollet
Information provided by (Responsible Party):
ResMed Identifier:
First received: July 29, 2007
Last updated: December 4, 2013
Last verified: December 2013
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

  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.
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
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 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   84   90   174 
>=65 years   67   57   124 
[Units: Years]
Mean (Standard Deviation)
 62.4  (9.1)   62.1  (9.0)   62.3  (9.0) 
[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 ]

  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:  
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: Jonathan Shaw, MD, FRACP, FRCP
Organization: Baker IDI Heart and Diabetes Institute
phone: +61 (0) 3 8532 1821

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: ResMed Identifier: NCT00509223     History of Changes
Other Study ID Numbers: CA-09-06-01
Study First Received: July 29, 2007
Results First Received: August 8, 2013
Last Updated: December 4, 2013