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New treatment option for Sleep Apnea, Obstructive
Official title Type 1 Diabetes and Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT06915831
What this study is testing
- What it's testing
- The purpose of the study is to investigate the role of sleep apnea in glycemic dysregulation in adults with Type 1 diabetes.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50
You may be able to join if
- 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...
- OSA by home sleep apnea test
You likely can't join if
- 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
See the full eligibility 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
- 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...
- Recent major surgery
- Major psychiatric disorder
- people 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...
- Currently pregnant or trying to get pregnant or nursing
- Smoking, alcohol or illegal drug abuse
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.