Type 1 Diabetes and Obstructive Sleep Apnea
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Chicago
About this trial
The purpose of the study is to investigate the role of sleep apnea in glycemic dysregulation in adults with Type 1 diabetes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Continuous positive airway pressure (CPAP)
DeviceAll-night CPAP will be applied with bedtimes 23:00h to 7:00h.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: UntreatedNo intervention 0 interventions
Group B: Treated: Continuous positive airway pressure (CPAP) treatmentActive comparator 1 intervention
Trial outcomes
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).
Time frame
Within 3 months of screeningSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Chicago
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov