Effect of Type 1 Diabetes on Sleep Fragmentation (DIAPASOM5)

July 26, 2021 updated by: University Hospital, Grenoble
The main objective of this study is the objective evaluation of disease related sleep fragmentation in subjects with type 1 diabetes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

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 Locations

  • France
      • Grenoble, France, 38043
        • Recruiting
        • Grenoble Alpes University Hospital
        • Sub-Investigator:
          • Pierre-Yves Benhamou, MD, PhD
        • Sub-Investigator:
          • Sandrine Lablanche, MD, PhD

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients having a self-reported type 1 diabetes

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Online questionnaire on the impact of type 1 diabetes on sleep quality
Other Names:
  • Online questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective sleep fragmentation
Time Frame: 1week
Number of self-reported awakenings by patients
1week
Subjective sleep quality
Time Frame: 1 week
Analogical scale (from 0 to 10) to grade overall sleep quality
1 week
Subjective impact of type 1 diabetes on sleep quality.
Time Frame: 1 week
Analogical scale (from 0 to 10) to grade overall sleep quality
1 week
Sleep fragmentation by subgroups
Time Frame: 1 week

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
1 week

Collaborators and Investigators

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

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Anne-Laure Borel, MD, PhD, Grenoble Alpes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 1, 2021

Primary Completion (ANTICIPATED)

November 1, 2021

Study Completion (ANTICIPATED)

May 1, 2022

Study Registration Dates

First Submitted

October 16, 2020

First Submitted That Met QC Criteria

October 19, 2020

First Posted (ACTUAL)

October 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 2, 2021

Last Update Submitted That Met QC Criteria

July 26, 2021

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC18.271
  • 2018-A02474-51 (OTHER: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

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.

Clinical Trials on Type 1 Diabetes

Clinical Trials on Cross-sectional observational study

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe