Type 1 Diabetes Clinical Trial
— DIADEMEOfficial title:
Effect of Continuous Positive Airway Pressure Treatment on Nocturnal Glycemia of Patients Having Type 1 Diabetes and Sleep Apnea Syndrome: a Randomized Controlled Trial
Hypothesis: To address the role of continuous positive airway pressure (CPAP)on nocturnal
glycemia in patients having type 1 diabetes and sleep apnea syndrome.
Investigators make the hypothesis that sleep apnea syndrome impacts nocturnal glycemia in
type 1 diabetic patients and that continuous positive airway pressure treatment will permit
to improve the nocturnal glycemic profile.
Study design: Adult patients with type 1 diabetes will be recruited for an extensive study
of sleep habits and assessment of sleep breathing disorders. When patients will present with
severe sleep apnea syndrome (apnea-hypopnea index above 30 events/hour) and insufficient
glycemic control (HbA1c > 7.5%), they will be randomized in continuous positive airway
pressure treatment or sham-continuous positive airway pressure treatment group for three
months.
Main outcome: Nocturnal glycemic control will be assessed for 5 days before and after three
months of the allocated treatment.
Status | Completed |
Enrollment | 81 |
Est. completion date | June 2015 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult patients with type 1 diabetes Exclusion Criteria: - Pregnant women - Patient with acute metabolic disorders during the past three months - Shift workers - Institutionalized patient - Enteral and parenteral nutrition |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Grenoble University hospital | Grenoble |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble | ResMed, Société francophone de pneumologie de langue francaise |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in mean nocturnal glycemia | Measured from continuous glycemic monitoring system | 3 months | No |
Secondary | Change in blood pressure | 24h ambulatory blood pressure monitoring | 3 months | No |
Secondary | Change in the variability of nocturnal glycemia | Measured on nighttime recording of continuous glycemic monitoring system | 3months | No |
Secondary | Change in HbA1c | 3 months | No | |
Secondary | Changes in sleep duration after intervention | Actimetry | 3 months | No |
Secondary | Change in mean systolic blood pressure after intervention | Self-monitoring blood pressure and heart rate device, at home | 3 months | No |
Secondary | Chang in sleep timing after intervention | Actimetry | 3 months | No |
Secondary | Change in daily activity after intervention | Actimetry | 3 months | No |
Secondary | Change in mean diastolic blood pressure after intervention | Self-monitoring blood pressure and heart rate device, at home | 3 months | No |
Secondary | Change in mean heart rate after intervention | Self-monitoring blood pressure and heart rate device, at home | 3 months | No |
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