Clinical trial NCT06915831: Type 1 Diabetes and Obstructive Sleep Apnea
Official title: Obstructive Sleep Apnea and Glycemic Dysregulation in Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sleep Apnea, Obstructive
Type 1 Diabetes (T1D)
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-04-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Within subjects design
Primary purpose: OTHER

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

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.

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

Primary outcomes:
measure: Glycemic variability
timeFrame: Within 3 months of screening
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Chicago
name: Esra Tasali, MD
role: PRINCIPAL_INVESTIGATOR
References: