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

Type 1 Diabetes Clinical Trial

— DIABNIGHT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05560568
• Other study ID #: 69HCL22_0533
• Status: Recruiting
• Start date: January 20, 2023
• Est. completion date: March 20, 2025

Study information

• Verified date: March 2024
• Source: Hospices Civils de Lyon
• Contact: THIVOLET Charles, MD
• Phone: +33 4.78.86.44.47
• Email: charles.thivolet[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 20, 2025
• Est. primary completion date: March 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients usually followed by the Diab-eCare service (HCL), male or female, between 18 and 50 years old,

• Confirmed diagnosis of type 1 diabetes for more than 1 year regardless of age of diagnosis,

• Eligible according to current recommendations and the center's practices for a hybrid closed-loop solution including all Dexcom G6,

• On pump, whatever the device used, for at least 6 months and with a Dexcom G6 CGM sensor for at least one month with more than 95% of data obtained,

• BMI<30 kg/m2,

• HbA1C <10%,

• Do not oppose to the said research.

Exclusion Criteria:

• Patients with type 2 diabetes,

• Patients with a cause other than diabetes that could disrupt sleep:

• Known or suspected sleep apnea syndrome with high risk according to the Berlin questionnaire, And/or

• Presence of risk factors such as severe retinopathy, nephropathy, hypertension, autonomic neuropathy, chronic psychiatric disorders, endocrine or metabolic pathologies that have not been stabilized, therapeutics that may alter sleep (i.e. sleeping pills, corticosteroids, antidepressants, anxiolytics, antihistamines), regular use of cannabis, abusive use of alcohol (regularly > 3 drinks per day for a man and > 2 drinks for a woman) And/or

• Night or shift work,

• Inability to collect data and/or understand the objectives of the study according to the investigator,

• Persons under legal protection,

• Persons not affiliated with a social security system

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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).

Locations

Country	Name	City	State
France	Centre du diabète Diab-eCare	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep efficiency	To evaluate if the optimization of glycemic control after 1 month of use of a hybrid closed loop improves sleep efficiency, i.e. the change of ratio of measured sleep time to time in bed * 100, evaluated by the actiwatch 2 (AW2) actigraph from inclusion (before the switch to the hybrid closed loop) to 1 month after the switch.	Change between inclusion and 1 month after the switch to the hybrid closed loop