NCT06915831 · University of Chicago
Type 1 Diabetes and Obstructive Sleep Apnea
(T1D and OSA)
What this study is about
The purpose of the study is to investigate the role of sleep apnea in glycemic dysregulation in adults with Type 1 diabetes.
View original scientific description
The purpose of the study is to investigate the role of sleep apnea in glycemic dysregulation in adults with Type 1 diabetes.
Interventions
DEVICE
Continuous positive airway pressure (CPAP)
All-night CPAP will be applied with bedtimes 23:00h to 7:00h.
Primary outcome measures
Glycemic variability
Time frame: Within 3 months of screening
Glycemic variability will be calculated using a standard metric as percent coefficient of variation (% CV) of glucose values obtained from continuous glucose monitoring (CGM).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Chicago, Illinois
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 20, 2026 · Source of record for eligibility and locations