Recruiting

Observational Study

Sponsor:

University of Chicago

Code:

NCT06915831

Conditions

Sleep Apnea, Obstructive

Type 1 Diabetes (T1D)

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Continuous positive airway pressure (CPAP)

Study Details

Brief summary:

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

Conditions

Sleep Apnea, Obstructive

Type 1 Diabetes (T1D)

Study ID

NCT06915831

Start date

Nov 10, 2025

Status verified date

Nov, 2025

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: Untreated

No treatment for OSA

active comparator: Treated: Continuous positive airway pressure (CPAP) treatment

Treatment for OSA by CPAP

Interventions

Continuous positive airway pressure (CPAP)

All-night CPAP will be applied with bedtimes 23:00h to 7:00h.

Primary outcome measure

  • Glycemic variability [ Time Frame: Within 3 months of screening ]

Central Contacts and Locations

Central contacts

Esra Tasali, MD

7738342663etasali@bsd.uchicago.edu

Becky Tucker

7737022348tuckerb@bsd.uchicago.edu

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Becky Tucker

773-702-2348tuckerb@bsd.uchicago.edu

More Information

Sponsor

University of Chicago

Last update posted

Jan 20, 2026

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-01-20.