Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-01-21 @ 10:00 PM
Study NCT ID:
NCT02796534
Status:
COMPLETED
Last Update Posted:
2023-05-12
First Post:
2016-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Obstructive Sleep Apnea Syndrome in Type 1 Diabetic Patients Treated With Insulin Pump (At1Home)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 825}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-11', 'studyFirstSubmitDate': '2016-05-23', 'studyFirstSubmitQcDate': '2016-06-09', 'lastUpdatePostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of obstructive sleep apnea syndrome by oxymetry, confirmed by polysomnography', 'timeFrame': '2 years', 'description': 'Number of patients presenting an obstructive apnea syndrome'}], 'secondaryOutcomes': [{'measure': 'Relationship between sleep apnea syndrome severity and micro/macro vascular complications of type 1 diabetes', 'timeFrame': '2 years', 'description': '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'}, {'measure': 'Relationship between sleep apnea syndrome severity and type 1 diabetes control', 'timeFrame': '2 years', 'description': 'Results from regularly prescribed HbA1c analysis will be collected'}, {'measure': 'Compliance of the Continuous Positive Airway Pressure (CPAP) after 3 months of use in patients with type 1 diabetes treated for severe SAS.', 'timeFrame': '2 years', 'description': 'Objective compliance to the CPAP treatment is daily recorded into the device and will be provided by home care provider'}, {'measure': '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', 'timeFrame': '2 years', 'description': 'New events will be collected by asking the patients, after 1 year and 2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obstructive Sleep Apnea Syndrome'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '19542208', 'type': 'BACKGROUND', 'citation': 'Borel AL, Benhamou PY, Baguet JP, Debaty I, Levy P, Pepin JL, Mallion JM. Short sleep duration is associated with a blood pressure nondipping pattern in type 1 diabetes: the DIAPASOM study. Diabetes Care. 2009 Sep;32(9):1713-5. doi: 10.2337/dc09-0422. Epub 2009 Jun 19.'}, {'pmid': '20950392', 'type': 'BACKGROUND', 'citation': 'Borel AL, Benhamou PY, Baguet JP, Halimi S, Levy P, Mallion JM, Pepin JL. High prevalence of obstructive sleep apnoea syndrome in a Type 1 diabetic adult population: a pilot study. Diabet Med. 2010 Nov;27(11):1328-9. doi: 10.1111/j.1464-5491.2010.03096.x. No abstract available.'}, {'pmid': '23715755', 'type': 'BACKGROUND', 'citation': 'Borel AL, Pepin JL, Nasse L, Baguet JP, Netter S, Benhamou PY. Short sleep duration measured by wrist actimetry is associated with deteriorated glycemic control in type 1 diabetes. Diabetes Care. 2013 Oct;36(10):2902-8. doi: 10.2337/dc12-2038. Epub 2013 May 28.'}, {'pmid': '24485855', 'type': 'BACKGROUND', 'citation': 'Pallayova M, Banerjee D, Taheri S. Novel insights into metabolic sequelae of obstructive sleep apnoea: a link between hypoxic stress and chronic diabetes complications. Diabetes Res Clin Pract. 2014 May;104(2):197-205. doi: 10.1016/j.diabres.2014.01.007. Epub 2014 Jan 14.'}, {'pmid': '19639001', 'type': 'BACKGROUND', 'citation': 'Seidell JC. Waist circumference and waist/hip ratio in relation to all-cause mortality, cancer and sleep apnea. Eur J Clin Nutr. 2010 Jan;64(1):35-41. doi: 10.1038/ejcn.2009.71. Epub 2009 Jul 29.'}, {'pmid': '21573904', 'type': 'BACKGROUND', 'citation': 'van Dijk M, Donga E, van Dijk JG, Lammers GJ, van Kralingen KW, Dekkers OM, Corssmit EP, Romijn JA. Disturbed subjective sleep characteristics in adult patients with long-standing type 1 diabetes mellitus. Diabetologia. 2011 Aug;54(8):1967-76. doi: 10.1007/s00125-011-2184-7. Epub 2011 May 15.'}, {'pmid': '10720054', 'type': 'BACKGROUND', 'citation': 'Vgontzas AN, Papanicolaou DA, Bixler EO, Hopper K, Lotsikas A, Lin HM, Kales A, Chrousos GP. Sleep apnea and daytime sleepiness and fatigue: relation to visceral obesity, insulin resistance, and hypercytokinemia. J Clin Endocrinol Metab. 2000 Mar;85(3):1151-8. doi: 10.1210/jcem.85.3.6484.'}, {'pmid': '16160020', 'type': 'BACKGROUND', 'citation': 'Young T, Peppard PE, Taheri S. Excess weight and sleep-disordered breathing. J Appl Physiol (1985). 2005 Oct;99(4):1592-9. doi: 10.1152/japplphysiol.00587.2005.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Type 1 patients treated by Insulin Pump.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 18 to 75 years\n* Type 1 diabetic\n* Treated on insulin therapy by external pump\n* Take home monitoring as part of a usual care for insulin therapy by external pump\n* Voluntary to participate in research with written informed consent\n* Patient affiliated to the social security or similar regime\n\nExclusion Criteria:\n\nPrivited person of liberty by judicial or administrative decision, person covered by legal protection (pregnant or lactating women, patients under guardianship) Article L1121-8\n\n* In exclusion period of other studies\n* Patient may, at the discretion of the investigator, not comply with the study procedures'}, 'identificationModule': {'nctId': 'NCT02796534', 'acronym': 'AT1Home', 'briefTitle': 'Prevalence of Obstructive Sleep Apnea Syndrome in Type 1 Diabetic Patients Treated With Insulin Pump (At1Home)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Prevalence of Obstructive Sleep Apnea Syndrome in Type 1 Diabetic Patients Treated With Insulin Pump (At1Home)', 'orgStudyIdInfo': {'id': '38RC14.199'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Diagnosis of sleep apnea by oxymetry', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Grenoble', 'state': 'Isère', 'country': 'France', 'facility': 'University Hospital Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Jean-Louis PEPIN, Md, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'VitalAire', 'class': 'INDUSTRY'}, {'name': 'ResMed', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}