Effect of Type 1 Diabetes on Sleep Fragmentation (DIAPASOM5)
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| ClinicalTrials.gov Identifier: NCT04601519 |
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Recruitment Status :
Recruiting
First Posted : October 23, 2020
Last Update Posted : August 2, 2021
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| Condition or disease | Intervention/treatment |
|---|---|
| Type 1 Diabetes | Other: Cross-sectional observational study |
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 Type : | Observational |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Effect of Type 1 Diabetes on Sleep Fragmentation |
| Actual Study Start Date : | July 1, 2021 |
| Estimated Primary Completion Date : | November 1, 2021 |
| Estimated Study Completion Date : | May 1, 2022 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Patients-type 1 diabetes
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.
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Other: Cross-sectional observational study
Online questionnaire on the impact of type 1 diabetes on sleep quality
Other Name: Online questionnaire |
- 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.
- Subjective sleep fragmentation [ Time Frame: 1week ]Number of self-reported awakenings by patients
- Subjective sleep quality [ Time Frame: 1 week ]Analogical scale (from 0 to 10) to grade overall sleep quality
- Subjective impact of type 1 diabetes on sleep quality. [ Time Frame: 1 week ]Analogical scale (from 0 to 10) to grade overall sleep quality
- Sleep fragmentation by subgroups [ Time Frame: 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04601519
| Contact: Anne-Laure Borel, MD, PhD | +33476765509 | alborel@chu-grenoble.fr | |
| Contact: Mbarka Daoukhi | MDaoukhi1@chu-grenoble.fr |
| France | |
| Grenoble Alpes university hospital | Recruiting |
| Grenoble, France, 38043 | |
| Contact: Anne-Laure Borel, MD, PhD +33476765509 alborel@chu-grenoble.fr | |
| Sub-Investigator: Pierre-Yves Benhamou, MD, PhD | |
| Sub-Investigator: Sandrine Lablanche, MD, PhD | |
| Principal Investigator: | Anne-Laure Borel, MD, PhD | Grenoble Alpes university hospital |
| Responsible Party: | University Hospital, Grenoble |
| ClinicalTrials.gov Identifier: | NCT04601519 |
| Other Study ID Numbers: |
38RC18.271 2018-A02474-51 ( Other Identifier: ID RCB ) |
| First Posted: | October 23, 2020 Key Record Dates |
| Last Update Posted: | August 2, 2021 |
| Last Verified: | October 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | There is a plan to make IPD and related data dictionaries available to perform meta-analyses based on individual data. The sharing of data will need the acceptation by the Principal Investigator. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Type1 diabetes Sleep fragmentation and quality of sleep the nocturia the hypoglycemias the hyperglycemias |
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Sleep Deprivation Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases |
Immune System Diseases Dyssomnias Sleep Wake Disorders Nervous System Diseases Neurologic Manifestations Mental Disorders |