NCT05560568Completed
Effects of Optimizing Nocturnal Glycemic Control on Sleep Parameters in Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 7 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 18 (actual)
- First submitted
- 22 Sept 2022
- Start date
- 20 Jan 2023
- Primary completion date
- 13 Jun 2024
- Lead sponsor
- Hospices Civils de Lyon
- Diseases
- Type 1 diabetes
- NCT number
- NCT05560568
What you commit to
- Study type: Observational
- Participants enrolled: 18
- From 20 Jan 2023 to the primary completion date, 13 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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,
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre du diabète DIAB-eCARE Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.