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

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

Sponsors

Lead Sponsor: University Hospital, Grenoble

Collaborator: Vitalaire
ResMed

Source 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.

Overall Status Recruiting
Start Date July 28, 2016
Completion Date July 28, 2020
Primary Completion Date July 28, 2018
Study Type Observational
Primary Outcome
Measure Time Frame
Prevalence of obstructive sleep apnea syndrome by oxymetry, confirmed by polysomnography 2 years
Secondary Outcome
Measure Time Frame
Relationship between sleep apnea syndrome severity and micro/macro vascular complications of type 1 diabetes 2 years
Relationship between sleep apnea syndrome severity and type 1 diabetes control 2 years
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
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
Enrollment 1025
Condition
Intervention

Intervention Type: Other

Intervention Name: Diagnosis of sleep apnea by oxymetry

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jean-Louis PEPIN, Md, PhD Principal Investigator University Hospital, Grenoble
Overall Contact

Last Name: Jean-Louis PEPIN, Md, PhD

Phone: +33476765522

Email: [email protected]

Location
Facility: Status: Contact: University Hospital Grenoble Marie PEETERS +33476769265 [email protected]
Location Countries

France

Verification Date

January 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Acronym AT1Home
Patient Data No
Study Design Info

Observational Model: Case-Only

Time Perspective: Prospective

Source: ClinicalTrials.gov