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Completed

NCT Number: NCT02796534

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

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Key information

Conditions

Type 1 Diabetes Apnea Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Grenoble

Grenoble, Isère, 38000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnosis of sleep apnea by oxymetry

Other

Primary outcomes

  1. Prevalence of obstructive sleep apnea syndrome by oxymetry, confirmed by polysomnography

    Time frame: 2 years

    Number of patients presenting an obstructive apnea syndrome

Secondary outcomes

  1. Relationship between sleep apnea syndrome severity and micro/macro vascular complications of type 1 diabetes

    Time frame: 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

  2. Relationship between sleep apnea syndrome severity and type 1 diabetes control

    Time frame: 2 years

    Results from regularly prescribed HbA1c analysis will be collected

  3. Compliance of the Continuous Positive Airway Pressure (CPAP) after 3 months of use in patients with type 1 diabetes treated for severe SAS.

    Time frame: 2 years

    Objective compliance to the CPAP treatment is daily recorded into the device and will be provided by home care provider

  4. 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

    Time frame: 2 years

    New events will be collected by asking the patients, after 1 year and 2 years

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • ResMed
  • VitalAire

Registry information

Acronym: AT1Home

Important dates

Study start
2016
Primary completion
2018
Study completion
2023
First posted
Jun 10, 2016
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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