Effect of Type 1 Diabetes on Sleep Fragmentation

NCT ID: NCT04601519

Last Updated: 2021-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-05-01

Brief Summary

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The main objective of this study is the objective evaluation of disease related sleep fragmentation in subjects with type 1 diabetes.

Detailed Description

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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

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Type 1 Diabetes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Cross-sectional observational study

Intervention Type OTHER

Online questionnaire on the impact of type 1 diabetes on sleep quality

Interventions

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Cross-sectional observational study

Online questionnaire on the impact of type 1 diabetes on sleep quality

Intervention Type OTHER

Other Intervention Names

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Online questionnaire

Eligibility Criteria

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Inclusion Criteria

* Self-reported type 1 diabetes
* Male or female
* Self-reported age \> 18 years old
* Subject user of a freestyle capillary meter

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne-Laure Borel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Grenoble Alpes university hospital

Locations

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Grenoble Alpes university hospital

Grenoble, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Anne-Laure Borel, MD, PhD

Role: CONTACT

+33476765509

Mbarka Daoukhi

Role: CONTACT

Facility Contacts

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Anne-Laure Borel, MD, PhD

Role: primary

+33476765509

References

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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.

Reference Type BACKGROUND
PMID: 27530460 (View on PubMed)

Larcher 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.

Reference Type BACKGROUND
PMID: 25623152 (View on PubMed)

Borel 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.

Reference Type BACKGROUND
PMID: 23715755 (View on PubMed)

Borel 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.

Reference Type BACKGROUND
PMID: 19542208 (View on PubMed)

Other Identifiers

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2018-A02474-51

Identifier Type: OTHER

Identifier Source: secondary_id

38RC18.271

Identifier Type: -

Identifier Source: org_study_id

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