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NCT Number: NCT06915831

Type 1 Diabetes and Obstructive Sleep Apnea

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

Recruiting

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

Location status: Recruiting

Location contact

Becky Tucker

CONTACT

[email protected]

773-702-2348

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Positive Airway Pressure (CPAP)

Device

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

Primary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Becky Tucker

CONTACT

[email protected]

7737022348

Esra Tasali, MD

CONTACT

[email protected]

7738342663

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: T1D and OSA

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Apr 8, 2025
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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