Effect of Sleep Apnea Treatment on Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— DIADEME  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02316665
• Other study ID #: 2012-A006336-40
• Status: Completed
• Phase: N/A
• First received: September 22, 2014
• Last updated: January 5, 2016
• Start date: April 2013
• Est. completion date: June 2015

Study information

• Verified date: January 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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.

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%.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Diabetes Mellitus, Type 1
• Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Type 1 Diabetes

Intervention

Device:
• continuous positive airway pressure
continuous positive airway pressure treatment during three months with adherence recording
• Sham-continuous positive airway pressure
Sham-continuous positive airway pressure during three months with adherence recording

Locations

Country	Name	City	State
France	Grenoble University hospital	Grenoble

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	ResMed, Société francophone de pneumologie de langue francaise

Country where clinical trial is conducted

France, 

Outcome

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