NCT06915831

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
40mo left

Started Nov 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Nov 2025Aug 2029

First Submitted

Initial submission to the registry

March 31, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

November 10, 2025

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

January 20, 2026

Status Verified

November 1, 2025

Enrollment Period

3.8 years

First QC Date

March 31, 2025

Last Update Submit

January 15, 2026

Conditions

Sleep Apnea, ObstructiveType 1 Diabetes (T1D)

Outcome Measures

Primary Outcomes (1)

  • Glycemic variability

    Glycemic variability will be calculated using a standard metric as percent coefficient of variation (% CV) of glucose values obtained from continuous glucose monitoring (CGM).

    Within 3 months of screening

Study Arms (2)

Untreated

NO INTERVENTION

No treatment for OSA

Treated: Continuous positive airway pressure (CPAP) treatment

ACTIVE COMPARATOR

Treatment for OSA by CPAP

Device: Continuous positive airway pressure (CPAP)

Interventions

Continuous positive airway pressure (CPAP)DEVICE

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

Treated: Continuous positive airway pressure (CPAP) treatment

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify 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 normal range at screening
  • OSA by home sleep apnea test

You may not qualify 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
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, ObstructiveDiabetes Mellitus, Type 1

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Esra Tasali, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Esra Tasali, MD

CONTACT

7738342663etasali@bsd.uchicago.edu

Becky Tucker

CONTACT

7737022348tuckerb@bsd.uchicago.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Within subjects design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2025

First Posted

April 8, 2025

Study Start

November 10, 2025

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

August 31, 2029

Last Updated

January 20, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)