Prevalence of Obstructive Sleep Apnea Syndrome in Type 1 Diabetic Patients Treated With Insulin Pump (At1Home)

Completed

• Conditions: Type 1 Diabetes

• Registration Number: NCT02796534
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-23
• Study First Submitted QC: 2016-06-09
• Study First Posted: 2016-06-10
• Study Start: 2016-07-28
• Primary Completion: 2018-07-28
• Study Completion: 2023-03-27
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 825

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of obstructive sleep apnea syndrome by oxymetry, confirmed by polysomnography	2 years	Number of patients presenting an obstructive apnea syndrome

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Grenoble; 🇫🇷 Grenoble, Isère, France