Obstructive sleep apnea and blood sugar control in adults with type 1 diabetes
Obstructive Sleep Apnea and Glycemic Dysregulation in Adults With Type 1 Diabetes
This project will try nightly CPAP to see if treating obstructive sleep apnea improves blood sugar control in adults with type 1 diabetes who use an insulin pump and continuous glucose monitoring.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06915831 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 18–50 with type 1 diabetes on an insulin pump, using a CGM with a GMI between 5.5 and 8.5%, and newly diagnosed moderate-to-severe obstructive sleep apnea by home testing are ideal candidates.
Not a fit: People who already use CPAP regularly, have recent severe hypoglycemia, major cardiovascular or renal disease, or other exclusionary comorbidities are unlikely to benefit from or be eligible for this protocol.
Why it matters
Potential benefit: If successful, nightly CPAP could improve overall glucose control and reduce glucose variability for adults with type 1 diabetes who have obstructive sleep apnea.
How similar studies have performed: CPAP has improved sleep quality and some metabolic measures in other populations and in type 2 diabetes, but evidence specifically demonstrating consistent glycemic benefit in adults with type 1 diabetes is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.