NCT05560568

Effects of Optimizing Nocturnal Glycemic Control on Sleep Parameters in Type 1 Diabetes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 18 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Sleep is crucial for physical and mental health. Environmental, social, or professional pressures can cause sleep duration to fall below the recommended 7-9 hours of sleep per night. Young adults with type 1 diabetes, have additional interference with fear, control and management of hypo/hyperglycemia management, alarms from their devices, which delay bedtime, disrupt sleep and generate multiple awakenings and difficulty returning to sleep. Sleep disturbance is correlated with blood glucose variability as recently demonstrated by a coupled analysis of sleep and glucose level collected by Continuous Glucose Monitoring (CGM). In this study, higher glucose variability predicted impaired sleep at the individual level. Automated insulin infusion has shown impressive results in clinical and real-life studies, with more than 90% of patients achieving good glycemic control. Il seems to improve sleep quality in subjects after 4 weeks in hybrid closed-loop, self-administered studies compared to a control group. The main objective of our study is to measure the positive influence of a better glycemic control on the different sleep parameters in subjects with type 1 diabetes at the time of the passage in hybrid closed-loop and in comparison to an identical period in open-loop.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
OTHER	Sleep parameters data collection	Sleep parameters collected before and after hybrid close-loop pump activation. Data collected with adequate devices (i.e. actigraph and Dreem Band).

Timeline

• Start date: 2023-01-20
• Primary completion: 2024-06-13
• Completion: 2024-06-13
• First posted: 2022-09-29
• Last updated: 2024-08-07

Locations

1 site across 1 country: France