Early Detection of noctUrnal hypoglyCemiA in TypE 2 Diabetes Using Pulse Rate Variability Measured by a Smartwatch(EDUCATED-Smartwatch)
Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05636007
Collaborator
(none)
150
1
8
18.8
Study Details
Study Description
Brief Summary
In patients with type 2 diabetes, it is necessary to identify and manage nocturnal hypoglycemia as early as possible, so as to reduce the damage caused by nocturnal hypoglycemia.We explore whether smartwatches can provide early warning of nocturnal hypoglycemic events in patients with type 2 diabetes by detecting changes in pulse variability.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Early Detection of noctUrnal hypoglyCemiA in TypE 2 Diabetes Using Pulse Rate Variability Measured by a Smartwatch(EDUCATED-Smartwatch)
Anticipated Study Start Date
:
Dec 1, 2022
Anticipated Primary Completion Date
:
Jul 1, 2023
Anticipated Study Completion Date
:
Aug 1, 2023
Outcome Measures
Primary Outcome Measures
- nocturnal hypoglycemia [8 months]
hypoglycemia occuring during 0AM to 6AM
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
-
- ≥18 years old 2.continuous glucose monitoring in patients with type 2 diabetes 3.Agreed to research into the group, and be able to sign the informed consent
Exclusion Criteria:
- 1.Arrhythmia, such as sinus arrest, sick sinus syndrome, atrial fibrillation, atrial flutter 2.Such as acute or chronic infectious diseases,hyperthyroidism and thyroid function did not return to normal pregnancy 3.nursing mothers
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Sun Yat-Sen University | Guangzhou | Guangdong | China | 510620 |
Sponsors and Collaborators
- Sun Yat-sen University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Xiao-dong Zhuang,
professor,
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT05636007
Other Study ID Numbers:
- EDUCATED-Smartwatch Study
First Posted:
Dec 2, 2022
Last Update Posted:
Dec 2, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: