Type 1 DiabetesDIAPASOM5NCT04601519
Effect of Type 1 Diabetes on Sleep Fragmentation
An observational study of Type 1 Diabetes, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The main objective of this study is the objective evaluation of disease related sleep fragmentation in subjects with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Cross-sectional observational study
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2021to 1 May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients having a self-reported type 1 diabetes
Who may be able to join
- Self-reported type 1 diabetes
- Male or female
- Self-reported age > 18 years old
- Subject user of a freestyle capillary meter
Who cannot join
- Opposition to Use of Data for Teaching and Research Purposes
- Other type of diabetes
- Self-reported age under 18 years of age
- Subject non-user of a freestyle capillary meter
Trial locations and contacts
1 site in 1 country.
Mbarka Daoukhi contact
France1 site, 1 recruiting
- Recruiting
Grenoble Alpes university hospital
Grenoble, 38043
Anne-Laure Borel, MD, PhD, +33476765509, alborel@chu-grenoble.fr
Pierre-Yves Benhamou, MD, PhD
About this study
The main objective of this study is the objective evaluation of disease related sleep fragmentation in subjects with type 1 diabetes.
Read the detailed description
The influence of sleep duration and sleep schedules (social jetlag) on glycemic control in type 1 diabetes has been shown in several previous studies, including by the investigators of this study.
Following these publications, patients have expressed the opinion via social networks that type 1 diabetes disease is itself a factor that alters the quality of sleep. Indeed, it appears that the cross-sectional studies published to date have focused on the association between the subjects' sleep habits and the balance of their diabetes, without having questioned the role of the pathology on sleep quality.
The main objective of this study is the objective evaluation of disease related sleep fragmentation in subjects with type 1 diabetes.
- Conditions
- Type 1 Diabetes
- Being tested
- Cross-sectional observational study
- Keywords
- Type1 diabetes, Sleep fragmentation and quality of sleep, the nocturia, the hypoglycemias, the hyperglycemias
- Medical subject headings
- Diabetes Mellitus, Type 1, Sleep Deprivation, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-sectional observational studyOther
Also called Online questionnaire
Online questionnaire on the impact of type 1 diabetes on sleep quality
| Study group | Role | What they receive |
|---|---|---|
| Patients-type 1 diabetes | Participants are recruited by e-mail, among the users of the libreview platform (Abbott), who are followed up for type 1 diabetes at the CHU Grenoble Alpes (France), to participate in an anonymous online questionnaire and to allow their glycemic data extracted from the libreview platform to be used for the research. Receives: Other: Cross-sectional observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective sleep fragmentation
Number of nocturnal awakenings objectively measured by the number of voluntary glycemia tests performed during the sleep period, according to freestyle recordings.
Measured: 1 week
Secondary outcomes (4)
Subjective sleep fragmentation
Number of self-reported awakenings by patients
Measured: 1week
Subjective sleep quality
Analogical scale (from 0 to 10) to grade overall sleep quality
Measured: 1 week
Subjective impact of type 1 diabetes on sleep quality.
Analogical scale (from 0 to 10) to grade overall sleep quality
Measured: 1 week
Sleep fragmentation by subgroups
Comparison of the number of nocturnal awakenings due to the disease between the following subgroups :
- Men versus women
- By age categories (quartiles)
- According to diabetes control
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start1 Jul 2021
- Primary completion1 Nov 2021 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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 only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Laure Borel, MD, PhD, Principal investigator, Grenoble Alpes university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601519
- Sponsor's protocol ID
- 38RC18.271
- Other IDs
- 2018-A02474-51
- Acronym
- DIAPASOM5
- Status last verified
- Oct 2020
- First submitted
- 16 Oct 2020
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is a plan to make IPD and related data dictionaries available to perform meta-analyses based on individual data. The sharing of data will need the acceptation by the Principal Investigator.
Publications
Larcher S, Gauchez AS, Lablanche S, Pepin JL, Benhamou PY, Borel AL. Impact of sleep behavior on glycemic control in type 1 diabetes: the role of social jetlag. Eur J Endocrinol. 2016 Nov;175(5):411-9. doi: 10.1530/EJE-16-0188. Epub 2016 Aug 16.
PubMed 27530460Larcher S, Benhamou PY, Pepin JL, Borel AL. Sleep habits and diabetes. Diabetes Metab. 2015 Sep;41(4):263-271. doi: 10.1016/j.diabet.2014.12.004. Epub 2015 Jan 23.
PubMed 25623152Borel AL, Pepin JL, Nasse L, Baguet JP, Netter S, Benhamou PY. Short sleep duration measured by wrist actimetry is associated with deteriorated glycemic control in type 1 diabetes. Diabetes Care. 2013 Oct;36(10):2902-8. doi: 10.2337/dc12-2038. Epub 2013 May 28.
PubMed 23715755Borel AL, Benhamou PY, Baguet JP, Debaty I, Levy P, Pepin JL, Mallion JM. Short sleep duration is associated with a blood pressure nondipping pattern in type 1 diabetes: the DIAPASOM study. Diabetes Care. 2009 Sep;32(9):1713-5. doi: 10.2337/dc09-0422. Epub 2009 Jun 19.
PubMed 19542208
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Type 1 Diabetes on Sleep Fragmentation
- ClinicalTrials.gov ID
- NCT04601519
- Acronym / sponsor ID
- DIAPASOM5 / 38RC18.271
- Conditions
- Type 1 Diabetes
- Keywords
- Type1 diabetes, Sleep fragmentation and quality of sleep, the nocturia, the hypoglycemias, the hyperglycemias
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 23 Oct 2020 (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.
The main objective of this study is the objective evaluation of disease related sleep fragmentation in subjects with type 1 diabetes.
Detailed description
The influence of sleep duration and sleep schedules (social jetlag) on glycemic control in type 1 diabetes has been shown in several previous studies, including by the investigators of this study.
Following these publications, patients have expressed the opinion via social networks that type 1 diabetes disease is itself a factor that alters the quality of sleep. Indeed, it appears that the cross-sectional studies published to date have focused on the association between the subjects' sleep habits and the balance of their diabetes, without having questioned the role of the pathology on sleep quality.
The main objective of this study is the objective evaluation of disease related sleep fragmentation in subjects with type 1 diabetes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients-type 1 diabetes | – | Other: Cross-sectional observational studyParticipants are recruited by e-mail, among the users of the libreview platform (Abbott), who are followed up for type 1 diabetes at the CHU Grenoble Alpes (France), to participate in an anonymous online questionnaire and to allow their glycemic data extracted from the libreview platform to be used for the research. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients having a self-reported type 1 diabetes
Key inclusion criteria (4 listed)
- Self-reported type 1 diabetes
- Male or female
- Self-reported age > 18 years old
- Subject user of a freestyle capillary meter
Key exclusion criteria (4 listed)
- Opposition to Use of Data for Teaching and Research Purposes
- Other type of diabetes
- Self-reported age under 18 years of age
- Subject non-user of a freestyle capillary meter
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 |
|---|---|---|
| Cross-sectional observational studyAlso: Online questionnaireOnline questionnaire on the impact of type 1 diabetes on sleep quality | Other | Patients-type 1 diabetes |
Primary outcome
Objective sleep fragmentation
Time frame: 1 week
Number of nocturnal awakenings objectively measured by the number of voluntary glycemia tests performed during the sleep period, according to freestyle recordings.
4 secondary outcomes
Subjective sleep fragmentation
Time frame: 1week
Subjective sleep quality
Time frame: 1 week
Subjective impact of type 1 diabetes on sleep quality.
Time frame: 1 week
Sleep fragmentation by subgroups
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Background: PubMed 27530460Larcher S, Gauchez AS, Lablanche S, Pepin JL, Benhamou PY, Borel AL. Impact of sleep behavior on glycemic control in type 1 diabetes: the role of social jetlag. Eur J Endocrinol. 2016 Nov;175(5):411-9. doi: 10.1530/EJE-16-0188. Epub 2016 Aug 16.
- Background: PubMed 25623152Larcher S, Benhamou PY, Pepin JL, Borel AL. Sleep habits and diabetes. Diabetes Metab. 2015 Sep;41(4):263-271. doi: 10.1016/j.diabet.2014.12.004. Epub 2015 Jan 23.
- Background: PubMed 23715755Borel AL, Pepin JL, Nasse L, Baguet JP, Netter S, Benhamou PY. Short sleep duration measured by wrist actimetry is associated with deteriorated glycemic control in type 1 diabetes. Diabetes Care. 2013 Oct;36(10):2902-8. doi: 10.2337/dc12-2038. Epub 2013 May 28.
- Background: PubMed 19542208Borel AL, Benhamou PY, Baguet JP, Debaty I, Levy P, Pepin JL, Mallion JM. Short sleep duration is associated with a blood pressure nondipping pattern in type 1 diabetes: the DIAPASOM study. Diabetes Care. 2009 Sep;32(9):1713-5. doi: 10.2337/dc09-0422. Epub 2009 Jun 19.
- Individual participant dataSharing planned: Undecided. There is a plan to make IPD and related data dictionaries available to perform meta-analyses based on individual data. The sharing of data will need the acceptation by the Principal Investigator.
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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.
Mbarka Daoukhi contact
Anne-Laure Borel, MD, PhD principal investigator
Grenoble Alpes university hospital
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 University Hospital, Grenoble 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Laure Borel, MD, PhD (+33476765509, alborel@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective sleep fragmentation (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04601519, which also lists 4 linked publications.
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 2 Aug 2021.