Type 1 Diabetes and Obstructive Sleep Apnea

Recruiting now · Not applicable

Conditions studied: Sleep Apnea, Obstructive, Type 1 Diabetes (T1D)

In brief

The purpose of the study is to investigate the role of sleep apnea in glycemic dysregulation in adults with Type 1 diabetes.

Key facts

Study ID

NCT06915831

Run by

University of Chicago

People needed

40

Starts

2025-11-10

Expected to finish

2029-08-31

Last updated by the study team

2026-01-20

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Chicago — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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