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

Last updated: August 6, 2024
Sponsor: Hospices Civils de Lyon
Overall Status: Completed

Phase

N/A

Condition

Diabetes Mellitus, Type 1

Diabetes And Hypertension

Diabetes Prevention

Treatment

Sleep parameters data collection

Clinical Study ID

NCT05560568
69HCL22_0533
  • Ages 18-50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofdiagnosis,

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

  • On pump, whatever the device used, for at least 6 months and with a Dexcom G6 CGMsensor 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

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 Berlinquestionnaire, And/or

  • Presence of risk factors such as severe retinopathy, nephropathy, hypertension,autonomic neuropathy, chronic psychiatric disorders, endocrine or metabolicpathologies 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 > 3drinks 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 tothe investigator,

  • Persons under legal protection,

  • Persons not affiliated with a social security system

Study Design

Total Participants: 18
Treatment Group(s): 1
Primary Treatment: Sleep parameters data collection
Phase:
Study Start date:
January 20, 2023
Estimated Completion Date:
June 13, 2024

Connect with a study center

  • Centre du diabète Diab-eCare

    Lyon, 69008
    France

    Site Not Available

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