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

The University of Chicago

Status: Enrolling

Conditions: Type 1 Diabetes (T1D); Sleep Apnea, Obstructive

Treatments: Device: Continuous positive airway pressure (CPAP)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06915831

IRB24-2170

1R01HL174685-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Untreated

No Intervention group

Description:

No treatment for OSA

Treated: Continuous positive airway pressure (CPAP) treatment

Active Comparator group

Description:

Treatment for OSA by CPAP

Treatment:

Device: Continuous positive airway pressure (CPAP)