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

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ClinicalTrials.gov Identifier: NCT02796534
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : July 11, 2016
Sponsor:
Collaborators:
Vitalaire
ResMed
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Type 1 Diabetes Other: Diagnosis of sleep apnea by oxymetry

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Study Type : Observational
Estimated Enrollment : 1025 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevalence of Obstructive Sleep Apnea Syndrome in Type 1 Diabetic Patients Treated With Insulin Pump (At1Home)
Study Start Date : September 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type 1 patients treated by Insulin Pump.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796534


Contacts
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Contact: Jean-Louis PEPIN, Md, PhD +33476765522 JPepin@chu-grenoble.fr
Contact: Renaud TAMISIER, Md, PhD +33476765385 RTamisier@chu-grenoble.fr

Locations
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France
University Hospital Grenoble Recruiting
Grenoble, Isère, France, 38000
Contact: Marie PEETERS    +33476769265    MPeeters@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
Vitalaire
ResMed
Investigators
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Principal Investigator: Jean-Louis PEPIN, Md, PhD University Hospital, Grenoble

Publications:

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02796534     History of Changes
Other Study ID Numbers: 38RC14.199
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Grenoble:
Obstructive Sleep Apnea Syndrome

Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Diabetes Mellitus, Type 1
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases