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Type 1 Diabetes and Obstructive Sleep Apnea

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 50 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how sleep apnea may affect blood sugar control in adults with type 1 diabetes. Sleep apnea means breathing stops and starts during sleep. The study is for adults ages 18 to 50 who use an insulin pump and a continuous glucose monitor.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 50 years old.
  • You have type 1 diabetes and use an insulin pump.
  • You use a continuous glucose monitor (CGM). Your GMI, an estimate of your average blood sugar, is 5.5% to 8.5%.
  • Your hemoglobin, a protein in red blood cells, is in the normal range at screening.
  • A home sleep test shows obstructive sleep apnea, where your airway gets blocked during sleep.

Who can't join

  • You regularly use CPAP as advised, or need oxygen or more advanced breathing support during sleep. CPAP is a machine that keeps your airway open.
  • You do shift work, or had an accident or near miss from falling asleep in the past 6 months.
  • You had severe low blood sugar in the past 3 months, cannot sense low blood sugar, or visited an emergency room for poor blood sugar control in the past 6 months.
  • You have advanced diabetes-related eye damage; fasting blood fats called triglycerides above 400 mg/dL; liver tests above twice the normal limit; a kidney transplant; or creatinine, a kidney blood test, above 1.5 mg/dL. Low hemoglobin also rules you out: below 13.0 g/dL for men or 11.6 g/dL for women.
  • You had a serious heart event or stroke in the past 6 months, or blood pressure above 180/105. Certain other serious heart problems, lung disease needing oxygen or daily airway-opening medicine, ongoing infections, or thyroid or other hormone disorders also rule you out.
  • You recently had major surgery or have a major mental health disorder.
  • You take medicines that could affect the study's tests: steroids that act throughout the body, antipsychotics, thiazide water pills, beta-blockers, daily aminophylline or theophylline, or medicines that weaken the immune system.
  • You are pregnant, trying to get pregnant, or breastfeeding. Smoking or misuse of alcohol or illegal drugs also rules you out.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

IL