Clinical trial NCT02796534: Prevalence of Obstructive Sleep Apnea Syndrome in Type 1 Diabetic Patients Treated With Insulin Pump (At1Home)
Official title: Prevalence of Obstructive Sleep Apnea Syndrome in Type 1 Diabetic Patients Treated With Insulin Pump (At1Home)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: Obstructive Sleep Apnea Syndrome
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: VitalAire
name: ResMed
First posted: 2016-06-10
Enrollment: 825
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 1 patients treated by Insulin Pump.

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.


Eligibility 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

Primary outcomes:
measure: Prevalence of obstructive sleep apnea syndrome by oxymetry, confirmed by polysomnography
timeFrame: 2 years
Secondary outcomes:
measure: Relationship between sleep apnea syndrome severity and micro/macro vascular complications of type 1 diabetes
timeFrame: 2 years
measure: Relationship between sleep apnea syndrome severity and type 1 diabetes control
timeFrame: 2 years
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
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
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
state: Isère
Study officials:
affiliation: University Hospital, Grenoble
name: Jean-Louis PEPIN, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.