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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre du diabète Diab-eCare

Lyon, 69008, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep parameters data collection

Other

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

Primary outcomes

Sleep efficiency

Time frame: Change between inclusion and 1 month after the switch to the hybrid closed loop

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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: DIABNIGHT

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Sep 29, 2022
Registry last updated: Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed