Clinical trial NCT04601519: Effect of Type 1 Diabetes on Sleep Fragmentation
Official title: Effect of Type 1 Diabetes on Sleep Fragmentation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 Diabetes
Keywords: Type1 diabetes
Sleep fragmentation and quality of sleep
the nocturia
the hypoglycemias
the hyperglycemias
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients having a self-reported type 1 diabetes

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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective sleep fragmentation
timeFrame: 1 week
Secondary outcomes:
measure: Subjective sleep fragmentation
timeFrame: 1week
measure: Subjective sleep quality
timeFrame: 1 week
measure: Subjective impact of type 1 diabetes on sleep quality.
timeFrame: 1 week
measure: Sleep fragmentation by subgroups
timeFrame: 1 week
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble Alpes university hospital
Study officials:
affiliation: Grenoble Alpes university hospital
name: Anne-Laure Borel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.