Type 1 Diabetes and Obstructive Sleep Apnea (T1D and OSA)

Obstructive Sleep Apnea and Glycemic Dysregulation in Adults With Type 1 Diabetes

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

Study Overview

• Status: Recruiting
• Conditions: Sleep Apnea, Obstructive; Type 1 Diabetes (T1D)
• Intervention / Treatment: Device: Continuous positive airway pressure (CPAP)

Detailed Description

Obstructive sleep apnea (OSA) is a common sleep disorder characterized by recurrent collapse of upper airway during sleep, resulting in intermittent hypoxia, sleep fragmentation by transient arousals, and poor sleep quality. Continuous positive airway pressure (CPAP), applied at night, is considered the treatment of choice for persons who are diagnosed with OSA. Current evidence suggests that OSA is highly prevalent in adults with T1D and particularly those with moderate-to-severe OSA have poorer glycemic control. Our overall goal is to investigate the role OSA in glycemic dysregulation in adults with T1D.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Becky Tucker; Phone Number: 7737022348; Email: tuckerb@bsd.uchicago.edu
• Study Contact Backup: Name: Esra Tasali, MD; Phone Number: 7738342663; Email: etasali@bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago
      • Contact: Becky Tucker; Phone Number: 773-702-2348; Email: tuckerb@bsd.uchicago.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Untreated; No treatment for OSA
Active Comparator: Treated: Continuous positive airway pressure (CPAP) treatment; Treatment for OSA by CPAP	Device: Continuous positive airway pressure (CPAP); All-night CPAP will be applied with bedtimes 23:00h to 7:00h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic variability	Glycemic variability will be calculated using a standard metric as percent coefficient of variation (% CV) of glucose values obtained from continuous glucose monitoring (CGM).	Within 3 months of screening

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Esra Tasali, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2025
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: March 31, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Respiratory Tract Diseases; Respiration Disorders; Glucose Metabolism Disorders; Diabetes Mellitus; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Nutritional and Metabolic Diseases; Sleep Apnea, Obstructive; Diabetes Mellitus, Type 1; Therapeutics; Airway Management; Respiratory Therapy; Positive-Pressure Respiration; Respiration, Artificial; Continuous Positive Airway Pressure
• Other Study ID Numbers: IRB24-2170; 1R01HL174685-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No