Status:
RECRUITING
Type 1 Diabetes and Obstructive Sleep Apnea
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sleep Apnea, Obstructive
Type 1 Diabetes (T1D)
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
The purpose of the study is to investigate the role of sleep apnea in glycemic dysregulation in adults with Type 1 diabetes.
Detailed Description
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,...
Eligibility Criteria
Inclusion
- 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
- Moderate to severe OSA by home sleep apnea test
Exclusion
- 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
Key Trial Info
Start Date :
November 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2029
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06915831
Start Date
November 10 2025
End Date
August 31 2029
Last Update
December 8 2025
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637