NCT04601519

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

August 2, 2021

Status Verified

October 1, 2020

Enrollment Period

4 months

First QC Date

October 16, 2020

Last Update Submit

July 26, 2021

Conditions

Type 1 Diabetes

Keywords

Type1 diabetesSleep fragmentation and quality of sleepthe nocturiathe hypoglycemiasthe hyperglycemias

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 week

Secondary Outcomes (4)

  • Subjective sleep fragmentation

    1week

  • Subjective sleep quality

    1 week

  • Subjective impact of type 1 diabetes on sleep quality.

    1 week

  • Sleep fragmentation by subgroups

    1 week

Study Arms (1)

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.

Other: Cross-sectional observational study

Interventions

Cross-sectional observational studyOTHER

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

Also known as: Online questionnaire
Patients-type 1 diabetes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients having a self-reported type 1 diabetes

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grenoble Alpes university hospital

Grenoble, 38043, France

RECRUITING

Related Publications (4)

  • 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.

    PMID: 27530460BACKGROUND

  • 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.

    PMID: 25623152BACKGROUND

  • 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.

    PMID: 23715755BACKGROUND

  • 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.

    PMID: 19542208BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Sleep DeprivationSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesDyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersSleep Disorders, Intrinsic

Study Officials

  • Anne-Laure Borel, MD, PhD

    Grenoble Alpes university hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Laure Borel, MD, PhD

CONTACT

+33476765509alborel@chu-grenoble.fr

Mbarka Daoukhi

CONTACT

MDaoukhi1@chu-grenoble.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2020

First Posted

October 23, 2020

Study Start

July 1, 2021

Primary Completion

November 1, 2021

Study Completion

May 1, 2022

Last Updated

August 2, 2021

Record last verified: 2020-10

Locations

FR(1)