Type 1 Diabetes
Conditions
Keywords
Obstructive Sleep Apnea Syndrome
Brief summary
Patients with type 1 diabetes have poorer glycemic control that could lead to macrovascular or neuropathic complications; in addition to an optimal treatment, prevention of diabetes complications requires to control associated risk factors, such as hypertension or dyslipidemia. Sleep apnea syndrome is a public health problem due to its high prevalence and marked morbidity and mortality, one increasingly interesting aspect is its relationship with metabolic disorders, specifically diabetes.Obstructive sleep apnea syndrome seems to be underestimated in this population. In this context, it appears to be important to estimate the prevalence of sleep respiratory diseases in patients with type 1 diabetes.
Interventions
OTHERDiagnosis of sleep apnea by oxymetry
Sponsors
VitalAire
ResMed
University Hospital, Grenoble
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18 to 75 years * Type 1 diabetic * Treated on insulin therapy by external pump * Take home monitoring as part of a usual care for insulin therapy by external pump * Voluntary to participate in research with written informed consent * Patient affiliated to the social security or similar regime
Exclusion criteria
Privited person of liberty by judicial or administrative decision, person covered by legal protection (pregnant or lactating women, patients under guardianship) Article L1121-8 * In exclusion period of other studies * Patient may, at the discretion of the investigator, not comply with the study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of obstructive sleep apnea syndrome by oxymetry, confirmed by polysomnography | 2 years | Number of patients presenting an obstructive apnea syndrome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relationship between sleep apnea syndrome severity and micro/macro vascular complications of type 1 diabetes | 2 years | Number and type of micro and macro vascular complications will be analysed from medical history and new events will be collected at each visit and validated by endocrinologist |
| Relationship between sleep apnea syndrome severity and type 1 diabetes control | 2 years | Results from regularly prescribed HbA1c analysis will be collected |
| Compliance of the Continuous Positive Airway Pressure (CPAP) after 3 months of use in patients with type 1 diabetes treated for severe SAS. | 2 years | Objective compliance to the CPAP treatment is daily recorded into the device and will be provided by home care provider |
| Incidence of new cardiovascular events and changes in microangiopathic complications of diabetes patients depending on the presence of sleep apnea syndrome and to the adherence to CPAP treatment in case of sleep apnea syndrome treated | 2 years | New events will be collected by asking the patients, after 1 year and 2 years |
Countries
France
Outcome results
None listed