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

August 6, 2024 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Lyon, France, 69008
        • Centre du diabète DIAB-eCARE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

20 adult patients with type 1 diabetes with an indication to switch to a hybrid closed-loop pump according to current recommendations. They will be informed of the study during a routine consultation at the Diab-eCare unit (Hospices Civils of Lyon, Lyon, France).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Adult patients with type 1 diabetes
Adult patients with type 1 diabetes treated with insulin pumps according to current recommendations with an indication to switch to a hybrid closed-loop pump
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change between inclusion and 1 month after the switch to the hybrid closed loop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 13, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 13, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL22_0533

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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