RecruitingNot ApplicableNCT06915831
Type 1 Diabetes and Obstructive Sleep Apnea
Obstructive Sleep Apnea and Glycemic Dysregulation in Adults With Type 1 Diabetes
Sponsor
University of Chicago
Enrollment
40 participants
Start Date
Nov 10, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of the study is to investigate the role of sleep apnea in glycemic dysregulation in adults with Type 1 diabetes.
Eligibility
Min Age: 18 YearsMax Age: 50 Years
Inclusion Criteria3
- 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 Criteria19
- 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
Interventions
DEVICEContinuous positive airway pressure (CPAP)
All-night CPAP will be applied with bedtimes 23:00h to 7:00h.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06915831
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