Effect of Type 1 Diabetes on Sleep Fragmentation

• Conditions: Type 1 Diabetes
• Interventions: Other: Cross-sectional observational study

• Registration Number: NCT04601519
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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 Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-16
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-23
• Study Start: 2021-07-01
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-08-02
• Primary Completion: 2021-11-01
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients-type 1 diabetes	Cross-sectional observational study	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.

Primary Outcome Measures

Name	Time	Method
Objective sleep fragmentation	1 week	Number of nocturnal awakenings objectively measured by the number of voluntary glycemia tests performed during the sleep period, according to freestyle recordings.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Grenoble Alpes university hospital; 🇫🇷 Grenoble, France