Type 1 Diabetes and Obstructive Sleep Apnea

Launched by UNIVERSITY OF CHICAGO · Mar 31, 2025

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