Prevalence of Obstructive Sleep Apnea Syndrome in Type 1 Diabetic Patients Treated With Insulin Pump (At1Home) (AT1Home)

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: Diagnosis of sleep apnea by oxymetry

• Study Type: Observational
• Enrollment (Actual): 825

Contacts and Locations

Study Locations

• France
  • Isère
    • Grenoble, Isère, France, 38000
      • University Hospital Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Type 1 patients treated by Insulin Pump.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of obstructive sleep apnea syndrome by oxymetry, confirmed by polysomnography	Number of patients presenting an obstructive apnea syndrome	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between sleep apnea syndrome severity and micro/macro vascular complications of type 1 diabetes	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	2 years
Relationship between sleep apnea syndrome severity and type 1 diabetes control	Results from regularly prescribed HbA1c analysis will be collected	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.	Objective compliance to the CPAP treatment is daily recorded into the device and will be provided by home care provider	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	New events will be collected by asking the patients, after 1 year and 2 years	2 years

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: ResMed; VitalAire
• Investigators: Principal Investigator: Jean-Louis PEPIN, Md, PhD, University Hospital, Grenoble

Publications and helpful links

General Publications

• Pepin JL, Bailly S, Texereau JB, Sonnet E, Picard S, Verges B, Coffin Boutreux C, Arnault Ouary G, Kessler L, Guerci B, Anton Kuchly B, Fendri Gaied S, Cuperlier A, Voinot C, Derrien C, Dubois S, Lavergne F, Borel AL, Tamisier R, Benhamou PY. Prevalence of sleep apnoea in patients with type 1 diabetes and its association with comorbidities and diabetic complications: A French nationwide prospective study. Diabetes Obes Metab. 2023 Jun;25(6):1624-1631. doi: 10.1111/dom.15015. Epub 2023 Mar 3.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2016
• Primary Completion (Actual): July 28, 2018
• Study Completion (Actual): March 27, 2023

Study Registration Dates

• First Submitted: May 23, 2016
• First Submitted That Met QC Criteria: June 9, 2016
• First Posted (Estimated): June 10, 2016

Study Record Updates

• Last Update Posted (Estimated): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Obstructive Sleep Apnea Syndrome
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Respiratory Tract Diseases; Respiration Disorders; Glucose Metabolism Disorders; Diabetes Mellitus; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Nutritional and Metabolic Diseases; Sleep Apnea, Obstructive; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 38RC14.199

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO