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

NCT02796534 | Completed

• 1 other identifier: 38RC14.199
• Study Type: observational
• Target: 825
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

Obstructive Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (1)

• Prevalence of obstructive sleep apnea syndrome by oxymetry, confirmed by polysomnography

  Number of patients presenting an obstructive apnea syndrome

  2 years

Secondary Outcomes (4)

• 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

Interventions

Diagnosis of sleep apnea by oxymetry OTHER

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Type 1 patients treated by Insulin Pump.

You may qualify if:

• 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

You may not qualify if:

• Privited person of liberty by judicial or administrative decision, person covered by legal protection (pregnant or lactating women, patients under guardianship) Article L1121-8
• Patient may, at the discretion of the investigator, not comply with the study procedures

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• VitalAire: collaborator
• ResMed: collaborator

Study Sites (1)

University Hospital Grenoble

Grenoble, Isère, 38000, France

Location

Related Publications (1)

• 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.

  PMID: 36792920 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jean-Louis PEPIN, Md, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: June 10, 2016
• Study Start: July 28, 2016
• Primary Completion: July 28, 2018
• Study Completion: March 27, 2023
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)