Effect of Type 1 Diabetes on Sleep Fragmentation

Type 1 Diabetes Clinical Trial

— DIAPASOM5  

Official title:

Effect of Type 1 Diabetes on Sleep Fragmentation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04601519
• Other study ID #: 38RC18.271
• Secondary ID: 2018-A02474-51
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: October 2020
• Source: University Hospital, Grenoble
• Contact: Anne-Laure Borel, MD, PhD
• Phone: +33476765509
• Email: alborel[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objective of this study is the objective evaluation of disease related sleep fragmentation in subjects with type 1 diabetes.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Sleep Deprivation
• Type 1 Diabetes

Intervention

Other:
• Cross-sectional observational study
Online questionnaire on the impact of type 1 diabetes on sleep quality

Locations

Country	Name	City	State
France	Grenoble Alpes university hospital	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (4)

Borel AL, Benhamou PY, Baguet JP, Debaty I, Levy P, Pépin 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. — View Citation

Borel AL, Pépin 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. — View Citation

Larcher S, Benhamou PY, Pépin 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. Review. — View Citation

Larcher S, Gauchez AS, Lablanche S, Pépin 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective sleep fragmentation	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	Subjective sleep fragmentation	Number of self-reported awakenings by patients	1week
Secondary	Subjective sleep quality	Analogical scale (from 0 to 10) to grade overall sleep quality	1 week
Secondary	Subjective impact of type 1 diabetes on sleep quality.	Analogical scale (from 0 to 10) to grade overall sleep quality	1 week
Secondary	Sleep fragmentation by subgroups	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