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

NCT ID: NCT02796534

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

825 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-28

Study Completion Date

2023-03-27

Brief Summary

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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

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Conditions

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Type 1 Diabetes

Keywords

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Obstructive Sleep Apnea Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Diagnosis of sleep apnea by oxymetry

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VitalAire

INDUSTRY

Sponsor Role collaborator

ResMed

INDUSTRY

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Louis PEPIN, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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University Hospital Grenoble

Grenoble, Isère, France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 36792920 (View on PubMed)

Other Identifiers

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38RC14.199

Identifier Type: -

Identifier Source: org_study_id