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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (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
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
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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: 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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo. 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. 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
e-mail: jonathan.shaw@bakeridi.edu.au

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

Shaw JE, Punjabi NM, Naughton MT, Willes L, Bergenstal RM, Cistulli PA, Fulcher GR, Richards GN, Zimmet PZ. The Effect of Treatment of Obstructive Sleep Apnea on Glycemic Control in Type 2 Diabetes. Am J Respir Crit Care Med. 2016 Aug 15;194(4):486-92. doi: 10.1164/rccm.201511-2260OC.

Responsible Party:	ResMed
ClinicalTrials.gov Identifier:	NCT00509223 History of Changes
Other Study ID Numbers:	CA-09-06-01
First Submitted:	July 29, 2007
First Posted:	July 31, 2007
Results First Submitted:	August 8, 2013
Results First Posted:	October 17, 2013
Last Update Posted:	December 30, 2013