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Effect of Type 1 Diabetes on Sleep Fragmentation

Effect of Type 1 Diabetes on Sleep Fragmentation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04601519
Acronym
DIAPASOM5
Enrollment
100
Registered
2020-10-23
Start date
2021-07-01
Completion date
2022-05-01
Last updated
2021-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

Type1 diabetes, Sleep fragmentation and quality of sleep, the nocturia, the hypoglycemias, the hyperglycemias

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.

Interventions

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

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Objective sleep fragmentation1 weekNumber of nocturnal awakenings objectively measured by the number of voluntary glycemia tests performed during the sleep period, according to freestyle recordings.

Secondary

MeasureTime frameDescription
Subjective sleep quality1 weekAnalogical scale (from 0 to 10) to grade overall sleep quality
Subjective impact of type 1 diabetes on sleep quality.1 weekAnalogical scale (from 0 to 10) to grade overall sleep quality
Subjective sleep fragmentation1weekNumber of self-reported awakenings by patients
Sleep fragmentation by subgroups1 weekComparison 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

Countries

France

Contacts

Primary ContactAnne-Laure Borel, MD, PhD
alborel@chu-grenoble.fr+33476765509
Backup ContactMbarka Daoukhi
MDaoukhi1@chu-grenoble.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026