The Effect of Treatment of OSA on Diabetes Self Management and Glycemic Control

描述（由申请人提供）：虽然糖尿病自我管理在过去30年中得到了改善和完善，但许多T2 DM患者仍然难以实现血糖目标。阻塞性睡眠呼吸暂停（OSA）在2型糖尿病（T2 DM）成人患者中的患病率很高，并与日间过度嗜睡、情绪受损、警惕性降低和功能结局降低相关。阻塞性睡眠呼吸暂停综合征影响糖尿病自我管理的程度，血糖控制的一个已知的决定因素，仍然没有研究。持续气道正压通气（CPAP）是治疗阻塞性睡眠呼吸暂停最有效的方法，可改善患者自我报告的日间功能。然而，CPAP治疗对接受糖尿病教育的影响尚不清楚。这项新研究的基本前提是OSA阻碍了T2 DM成人的糖尿病自我管理。这项研究扩展了我们的试点/可行性研究，该研究表明CPAP治疗与疲劳减少，体力活动增加和血糖控制改善相关。我们的目标是提高对OSA对糖尿病自我管理的影响的理解，并确定CPAP治疗在改善接受CPAP治疗的成年人与接受假CPAP治疗的成年人的糖尿病结局方面的疗效。我们计划招收210名成人50%女性; 40%的少数民族）患有T2 DM和中度至重度OSA（呼吸暂停+呼吸不足指数> 15）血糖控制欠佳的患者（A1 C e 7.0%）为双盲、随机、安慰剂对照试验，以确定糖尿病是否自我-接受CPAP治疗并接受糖尿病教育和咨询的OSA受试者的管理结果和血糖控制优于接受假手术的对照受试者，接受CPAP治疗和糖尿病教育。我们将比较干预6周和12周后血糖控制措施的有效性，保留在糖尿病教育课程中教授的信息，最佳糖尿病控制所需的生活方式行为，自我管理活动的监测报告，体力活动和糖尿病相关的痛苦。我们将探讨CPAP的平均夜间使用（依从性）、睡眠质量、白天嗜睡、情绪和警惕性是否介导CPAP治疗对血糖控制和糖尿病自我管理结果的影响。我们还将探讨在治疗性CPAP 24周后，整个样本中CPAP的依从性是否与血糖控制和生活方式行为的结局指标相关。本研究采用客观的方法来测量CPAP依从性、体力活动、警惕性和血糖控制。12周后，最初接受假CPAP的受试者将交叉至活性治疗。这项研究的总体影响将增加有关睡眠呼吸暂停对糖尿病自我管理影响的知识。扩大我们对睡眠障碍对糖尿病自我管理的影响的理解，可能会导致越来越多的糖尿病患者中OSA筛查和治疗指南的改进。

DESCRIPTION (provided by applicant): While diabetes self-management has been improved and refined over the last 30 years, many persons with T2DM continue to have difficulty in achieving glycemic goals. Obstructive sleep apnea (OSA) has a high prevalence among adults with type 2 diabetes (T2DM) and is associated with excessive daytime sleepiness, impaired mood, decreased vigilance, and reduced functional outcomes. The degree that OSA affects diabetes self-management, a known determinant of glycemic control, remains unstudied. The most effective treatment for OSA, continuous positive airway pressure (CPAP), results in improved self-reported daytime functioning. However, the effect of CPAP treatment on reception of diabetes education remains unknown. The underlying premise of the proposed study from this new investigator is that OSA hinders diabetes self-management in adults with T2DM. This study expands on our pilot/feasibility study that suggested that CPAP treatment is associated with decreased fatigue, increased physical activity, and improved glucose control. Our goal is to improve understanding of the effect of OSA on diabetes self-management and to determine the efficacy of CPAP treatment in improving diabetes outcomes in adults treated with CPAP compared to those on sham- CPAP. We propose to enroll 210 adults (50 percent female; 40 percent minority) with T2DM and moderate-to-severe OSA (apnea + hypopnea index > 15) who have suboptimal glycemic control (A1C e 7.0 percent) for a double blind, randomized, placebo-controlled trial to determine if diabetes self-management outcomes and glycemic control are better in subjects with OSA who are treated with CPAP and receive diabetes education and counseling compared to control subjects who are on sham-CPAP and receive diabetes education. We will compare the effectiveness of the intervention after 6 weeks and 12 weeks on measures of glycemic control, retention of information taught during the diabetes education sessions, lifestyle behaviors required for optimal diabetes control, reported monitoring of self-management activities, physical activity, and diabetes-related distress. We will explore whether the average nighttime use (adherence) of CPAP, sleep quality, daytime sleepiness, mood, and vigilance mediate the effect of CPAP treatment on glycemic control and diabetes self-management outcomes. We will also explore if adherence to CPAP is associated with outcome measures of glycemic control and lifestyle behaviors in the entire sample after 24 weeks of therapeutic CPAP. This study uses objective measures to measure CPAP adherence, physical activity, vigilance, and glycemic control. After 12-weeks, subjects who were originally on sham-CPAP will be crossed over to active treatment. The overall impact of this study will be increased knowledge about the effect of sleep apnea on diabetes self-management. Expanding our understanding of the effect of sleep disturbances on diabetes self-management may lead to improved guidelines for screening and treatment of OSA in the increasingly large portion of the population with diabetes.