Effect of Type 1 Diabetes on Sleep Fragmentation
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Objective sleep fragmentation
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Subjective sleep fragmentation(1week)
- Subjective impact of type 1 diabetes on sleep quality.(1 week)
- Subjective sleep quality(1 week)
- Sleep fragmentation by subgroups(1 week)