Type 1 Diabetes and Obstructive Sleep Apnea
Launched by UNIVERSITY OF CHICAGO · Mar 31, 2025
Trial Information
Current as of July 09, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how obstructive sleep apnea (OSA) affects blood sugar control in adults with Type 1 diabetes (T1D). Researchers want to understand if having sleep apnea makes it harder for people with T1D to manage their glucose levels effectively. The trial is not yet recruiting participants, but it aims to include adults aged 18 to 50 who have been living with Type 1 diabetes for 3 to 20 years and use an insulin pump along with a continuous glucose monitor (CGM). To qualify, participants need to show signs of moderate to severe sleep apnea as determined by a home sleep test.
If you or someone you know fits these criteria, participating in the trial could provide valuable insights into the connection between sleep apnea and diabetes management. However, there are certain health conditions that would exclude someone from participating, such as severe high blood pressure, recent serious health events like a heart attack or stroke, or if you are currently pregnant or nursing. Participants can expect to undergo assessments that will help researchers learn more about how sleep apnea impacts blood sugar levels in people with Type 1 diabetes, which could lead to better treatment options in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age: 18 to 50 years old
- • Type 1 Diabetes (duration 3-20 years) 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 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
About University Of Chicago
The University of Chicago is a prestigious research institution renowned for its commitment to advancing medical science through innovative clinical trials. With a robust infrastructure that supports multidisciplinary collaboration, the University actively engages in cutting-edge research across various therapeutic areas. Its dedicated team of experienced investigators and state-of-the-art facilities enable the University of Chicago to conduct rigorous clinical studies aimed at improving patient outcomes and translating scientific discoveries into tangible healthcare solutions. The institution prioritizes ethical standards and patient safety, ensuring that all trials adhere to the highest regulatory guidelines and best practices in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Esra Tasali, MD
Principal Investigator
University of Chicago
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported