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

Type 1 Diabetes Clinical Trial

— AT1Home  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02796534
• Other study ID #: 38RC14.199
• Status: Completed
• Start date: July 28, 2016
• Est. completion date: March 27, 2023

Study information

• Verified date: May 2023
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 825
• Est. completion date: March 27, 2023
• Est. primary completion date: July 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Type 1 Diabetes

Intervention

Other:
• Diagnosis of sleep apnea by oxymetry

Locations

Country	Name	City	State
France	University Hospital Grenoble	Grenoble	Isère

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	ResMed, VitalAire

Country where clinical trial is conducted

France, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of obstructive sleep apnea syndrome by oxymetry, confirmed by polysomnography	Number of patients presenting an obstructive apnea syndrome	2 years
Secondary	Relationship between sleep apnea syndrome severity and micro/macro vascular complications of type 1 diabetes	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 years
Secondary	Relationship between sleep apnea syndrome severity and type 1 diabetes control	Results from regularly prescribed HbA1c analysis will be collected	2 years
Secondary	Compliance of the Continuous Positive Airway Pressure (CPAP) after 3 months of use in patients with type 1 diabetes treated for severe SAS.	Objective compliance to the CPAP treatment is daily recorded into the device and will be provided by home care provider	2 years
Secondary	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	New events will be collected by asking the patients, after 1 year and 2 years	2 years