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
Results First Received: August 8, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   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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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects for this study were recruited from 15 medical clinics located in the United States and Australia.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were presented with an Informed Consent Form (and HIPAA in USA) and assessed for eligibility based on inclusion /exclusion criteria. If all IEC met, subjects randomized 1:1. 118 subjects not included in endpoint analysis due to reanalysis of Obstructive Sleep Apnea (OSA) inclusion criteria. 298 of the 416 were included for final analysis.

Reporting Groups
  Description
Group 1

Lifestyle counseling with Positive Airway Pressure (PAP) therapy

Lifestyle counseling: All subjects were counseled regarding adopting a healthy lifestyle and advised on the Heart Foundation, National Health and Medical Research Council, and American Diabetes Association nutrition and exercise recommendations.

Positive Airway Pressure therapy : PAP therapy was initiated at Randomization and continued through the entire study duration (6 months), with instructions for use on a daily basis, during periods of sleep.

Group 2

Lifestyle counseling without Positive Airway Pressure (PAP) therapy

Lifestyle counseling: All subjects were counseled regarding adopting a healthy lifestyle and advised on the Heart Foundation, National Health and Medical Research Council, and American Diabetes Association nutrition and exercise recommendations.


Participant Flow:   Overall Study
    Group 1     Group 2  
STARTED     207     209  
COMPLETED     119     137  
NOT COMPLETED     88     72  
Lost to Follow-up                 1                 1  
Adverse Event                 1                 1  
Withdrawal by Subject                 25                 6  
Including: subject change of address                 5                 2  
Did not meet revised inclusion criteria                 56                 62  



  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  
Number of Participants  
[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 ]


  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