Type 1 DiabetesDIABNIGHTNCT05560568
Effects of Optimizing Nocturnal Glycemic Control on Sleep Parameters in Type 1 Diabetes
An observational study of Type 1 Diabetes, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Sleep parameters data collection
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2023to 13 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
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).
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Type 1 Diabetes
- Being tested
- Sleep parameters data collection
- Keywords
- Type 1 Diabetes, Sleep, nocturnal glycemic control
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep parameters data collectionOther
Sleep parameters collected before and after hybrid close-loop pump activation. Data collected with adequate devices (i.e. actigraph and Dreem Band).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Sleep parameters data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change between inclusion and 1 month after the switch to the hybrid closed loop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start20 Jan 2023
- Primary completion13 Jun 2024
- Study completion13 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560568
- Sponsor's protocol ID
- 69HCL22_0533
- Acronym
- DIABNIGHT
- Status last verified
- Aug 2024
- First submitted
- 22 Sep 2022
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Optimizing Nocturnal Glycemic Control on Sleep Parameters in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05560568
- Acronym / sponsor ID
- DIABNIGHT / 69HCL22_0533
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Sleep, nocturnal glycemic control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 13 Jun 2024 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with type 1 diabetes | – | Other: Sleep parameters data collectionAdult patients with type 1 diabetes treated with insulin pumps according to current recommendations with an indication to switch to a hybrid closed-loop pump |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (8 listed)
- Patients with type 2 diabetes,
- Patients with a cause other than diabetes that could disrupt sleep:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep parameters data collectionSleep parameters collected before and after hybrid close-loop pump activation. Data collected with adequate devices (i.e. actigraph and Dreem Band). | Other | Adult patients with type 1 diabetes |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep efficiency (time frame: Change between inclusion and 1 month after the switch to the hybrid closed loop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.