Prevalence of Sleep Apnea Syndrome in Patients With Type 1 Diabetes

NCT03506022 | Completed

• 1 other identifier: PI2017_843_0019
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea (OSA) and Type 2 diabetes are two frequent diseases that occur in adult population. The prevalence of OSA is higher in people with Type 2 diabetes compared with the general population7 ; in addition, the OSA syndrome is almost assessed in obese type 2 diabetes. The relationship between OSA and Type 2 diabetes has been well characterized: the OSA can contribute to increased insulin resistance or glucose intolerance; and, diabetes may worsen sleep-disordered breathing because of autonomic neuropathy8,9. The main link between OSA and Type 2 diabetes is central obesity, which triggers glucose intolerance/insulin resistance and is also an independent risk factor for OSA. Type 1 diabetes is generally not related to obesity; however, sleep-disordered breathing in these patients was described in few reports early as 1985 by pioneers such as Guilleminault5 and the prevalence of OSA is estimated at range 10 to 40% in type 1 diabetes patients. Few studies had evaluated the prevalence of sleep disorders in particular the sleep apnea syndrome in patients with type 1 diabetes and even less their influence on the glycemic control. This study will take place at the CHU of Amiens-Picardie during a one-night hospitalization. The investigators will study in 44 type 1 diabetes mellitus (IAH apnea hypopnea index ≥15) who underwent polysomnography and continuous glucose monitoring of blood glucose

Conditions

Diabetes Mellitus, Type 1

Keywords

Sleep apnea syndrome, polysomnography and glucose monitoring continu glycemia (CGMS )

Outcome Measures

Primary Outcomes (1)

• Prevalence of obstructive sleep apnea syndrome confirmed by polysomnography an apnea hypopnea Index ≥ 15

  3 month

Study Arms (1)

patients with type 1 mellitus diabetes

OTHER

All participants were admitted in sleep laboratory and screened for one night of 8 hours employing standard polysomnography (Brainnet System - Medatec) parameters

Other: standard polysomnography

Interventions

standard polysomnography OTHER

All participants were admitted in sleep laboratory and screened for one night of 8 hours employing standard polysomnography (Brainnet System - Medatec) parameters : electroencephalogram, electro-oculogram, electromyogram \[chin\], continuous nasal airflow body position, thoracic and abdominal strain gauges, haemoglobin oxygen saturation (SaO2) with an oximeter (Medatec) attached to finger. Blood pressure was measured in the evening during the physical examines, and then the CGMS recording startedpressure was measured in the evening during the physical examines, and then the CGMS recording started

patients with type 1 mellitus diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients over 18 years
• with type 1 mellitus diabetes

You may not qualify if:

• Type-free diabetes (type 1 slow),
• Age \<18 years
• A poor compliance with the follow-up (meetings unfulfilled without justification).
• All patients with known sleep disorders (OSA, narcolepsy, idiopathic hypersomnia).

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

Chu Amiens Picardie

Amiens, Picardie, 80000, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients over 18 years with type 1 mellitus diabetes will be included. The exclusion criteria are type-free diabetes (type 1 slow), age \<18 years, a poor compliance with the follow-up (meetings unfulfilled without justification). All patients with known sleep disorders (OSA, narcolepsy, idiopathic hypersomnia).

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: April 23, 2018
• Study Start: January 12, 2018
• Primary Completion: April 11, 2019
• Study Completion: April 11, 2019
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

FR (1)