Effect of Sleep Apnea Treatment on Type 1 Diabetes (DIADEME)

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes; Sleep Apnea Syndrome
• Intervention / Treatment: Device: continuous positive airway pressure; Device: Sham-continuous positive airway pressure

Detailed Description

Quality of clinical study procedures will be checked by on-site audit.

Patient self-reported past medical history will be checked by reviewing medical records.

Paper case report forms will be used.

For the baseline extensive study of sleep habits, the following data are recorded:

• Self-reported sleep diary (7 days)
• Actimetric device (7 days)
• Munich Chronotype Questionnaire
• 24h-dietary recall
• Salivary collections every 30 minutes between 7:30 pm and 22:00 pm on one night to address the dim light melatonin onset.
• Other questionnaires: Job strain questionnaire, EPICES (precarity questionnaire) and DQOL (diabetes related quality of life)
• Nocturnal oxymetry

Blood measurements: HbA1c, lipidic profile, microalbuminuria, creatinin

After baseline assessment, patients having an abnormal nocturnal oximetry will be explored by polysomnography in order to detect a sleep apnea syndrome.

Investigators anticipate, based on a previous pilot study of our group ("Borel" Diab Med 2010), that 30% of screened patients will present with sleep apnea.

If patients present with severe sleep apnea (IAH > 30 events/hour) and HbA1c > 7.5%, they will be randomized for the intervention.

Sample size: based on a previous study by "Pallayova" et al. in patients having type 2 diabetes, investigators anticipate a difference between groups of 1.3 (SD 2.07) for the mean nocturnal glycemia. For a alpha threshold of 5% and a study power of 80%, the study should include 32 patients in each group. Taking in account a possible 25% of dropout the study will need to include 40 patients by randomized arm to demonstrate an effect.

Statistical analysis: An intention-to-treat analysis will be performed. Missing data for the continuous positive airway pressure group will be replaced by the median value at three-month of the sham-continuous positive airway pressure group and reciprocally.

In a second analysis, a per-protocol analysis will be performed limited to patients having completed their treatment in allocated group and having an adherence to continuous positive airway pressure or sham-continuous positive airway pressure treatment for more than 4-hours a night.

Normality of data will be checked by Kurtosis and Skewness tests. The significance level will be set at 5%.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Grenoble University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: continuous positive airway pressure; Patients will receive continuous positive airway pressure during three months	Device: continuous positive airway pressure; continuous positive airway pressure treatment during three months with adherence recording
Sham Comparator: Sham-continuous positive airway pressure; Patients will receive sham-continuous positive airway pressure during 3 months	Device: Sham-continuous positive airway pressure; Sham-continuous positive airway pressure during three months with adherence recording

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in mean nocturnal glycemia	Measured from continuous glycemic monitoring system	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c		3 months
Change in blood pressure	24h ambulatory blood pressure monitoring	3 months
Change in the variability of nocturnal glycemia	Measured on nighttime recording of continuous glycemic monitoring system	3months
Changes in sleep duration after intervention	Actimetry	3 months
Change in mean systolic blood pressure after intervention	Self-monitoring blood pressure and heart rate device, at home	3 months
Chang in sleep timing after intervention	Actimetry	3 months
Change in daily activity after intervention	Actimetry	3 months
Change in mean diastolic blood pressure after intervention	Self-monitoring blood pressure and heart rate device, at home	3 months
Change in mean heart rate after intervention	Self-monitoring blood pressure and heart rate device, at home	3 months

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: ResMed; Société francophone de pneumologie de langue francaise
• Investigators: Principal Investigator: Jean-Louis Pépin, MD PhD, HP2 INSERM U1042 laboratory, France

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: September 22, 2014
• First Submitted That Met QC Criteria: December 10, 2014
• First Posted (Estimate): December 15, 2014

Study Record Updates

• Last Update Posted (Estimate): January 6, 2016
• Last Update Submitted That Met QC Criteria: January 5, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Type 1 diabetes; Continuous positive airway pressure; Continuous glucose monitoring system; Sleep apnea syndrome; Nocturnal glycemia; Sleep habits
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Endocrine System Diseases; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Diabetes Mellitus; Syndrome; Diabetes Mellitus, Type 1; Apnea
• Other Study ID Numbers: 2012-A006336-40