Obstructive sleep apnea and blood sugar control in adults with type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolls adults aged 18–50 with type 1 diabetes on insulin pump therapy and a CGM-driven glucose management indicator in a specified range, who are diagnosed with obstructive sleep apnea by a home sleep test. Participants will use continuous positive airway pressure (CPAP) at night and have their glucose patterns monitored via CGM and laboratory measures. The protocol excludes people already adherent to CPAP, those with recent severe hypoglycemia or major comorbidities, and others with conditions that could confound outcomes. The goal is to link changes in sleep-disordered breathing with changes in glycemic control.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Chicago
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Esra Tasali, MD — University of Chicago
• Study coordinator: Esra Tasali, MD
• Email: etasali@bsd.uchicago.edu
• Phone: 7738342663

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.