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Type 1 Diabetes and Obstructive Sleep Apnea
NCT06915831 · University of Chicago
In plain English
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Official title
Obstructive Sleep Apnea and Glycemic Dysregulation in Adults With Type 1 Diabetes
About this study
Obstructive sleep apnea (OSA) is a common sleep disorder characterized by recurrent collapse of upper airway during sleep, resulting in intermittent hypoxia, sleep fragmentation by transient arousals, and poor sleep quality. Continuous positive airway pressure (CPAP), applied at night, is considered the treatment of choice for persons who are diagnosed with OSA. Current evidence suggests that OSA is highly prevalent in adults with T1D and particularly those with moderate-to-severe OSA have poorer glycemic control. Our overall goal is to investigate the role OSA in glycemic dysregulation in adults with T1D.
Eligibility criteria
Inclusion Criteria:
* Age: 18 to 50 years old
* Type 1 Diabetes on insulin pump therapy and using a CGM device with an GMI (glucose management indicator) between 5.5 and 8.5% with hemoglobin in the normal range at screening
* OSA by home sleep apnea test
Exclusion Criteria:
* Regular and adherent CPAP use per clinical guidelines
* Requiring oxygen or advanced positive airway pressure modalities during sleep
* Having a 'fall-asleep' or 'near miss' accident in the past 6-months
* Shift work
* Severe hypoglycemia (≥1 episode in the past 3 months or diagnosis of hypoglycemic unawareness)
* ≥1 trip to emergency room for poor glucose management in the past 6 months
* Proliferative retinopathy
* Fasting triglycerides \>400mg/dL,
* Liver transaminases \>2 times upper limit of normal,
* Renal transplantation or serum creatinine \>1.5 mg/dL
* Anemia (hemoglobin \<13.0g/dL in men or \<11.6g/dL in women)
* Acute coronary syndrome or stroke past 6 months
* Severe hypertension (blood pressure\>180/105 mmHg)
* Any other significant health condition: unstable angina, heart failure requiring hospitalization in the past 6 months, significant heart block or arrhythmias, NYHA Class\>2, pulmonary disease with dependence on oxygen or daily use of bronchodilators, active or chronic infection, thyroid disease and other endocrine disorders (e.g. Cushing syndrome, acromegaly)
* Recent major surgery
* Major psychiatric disorder
* Subjects will also be excluded if taking medications that can confound metabolic assessments including systemic glucocorticoids, antipsychotics, thiazide diuretics, beta-blockers, daily use of aminophylline or theophylline, or use of any immunosuppressant.
* Currently pregnant or trying to get pregnant or nursing
* Smoking, alcohol or illegal drug abuse
Study design
Enrollment target: 40 participants
Allocation: randomized
Masking: none
Age groups: adult
Timeline
Starts: 2025-11-10
Estimated completion: 2029-08-31
Last updated: 2026-01-20
Interventions
Device: Continuous positive airway pressure (CPAP)
Primary outcomes
- • Glycemic variability (Within 3 months of screening)
Sponsor
University of Chicago · other
With: National Heart, Lung, and Blood Institute (NHLBI)
Contacts & investigators
ContactEsra Tasali, MD · contact · etasali@bsd.uchicago.edu · 7738342663
ContactBecky Tucker · contact · tuckerb@bsd.uchicago.edu · 7737022348
InvestigatorEsra Tasali, MD · principal_investigator, University of Chicago
All locations (1)
University of ChicagoRecruiting
Chicago, Illinois, United States