Early Detection of noctUrnal hypoglyCemiA in TypE 2 Diabetes Using Pulse Rate Variability Measured by a Smartwatch(EDUCATED-Smartwatch)

Recruiting

• Conditions: Hypodlycemia

• Registration Number: NCT05636007
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-22
• Study First Submitted QC: 2022-11-22
• Last Update Submitted: 2022-11-22
• Study Start: 2022-12-01
• Study First Posted: 2022-12-02
• Last Update Posted: 2022-12-02
• Primary Completion: 2023-07-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 1. ≥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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
nocturnal hypoglycemia	8 months	hypoglycemia occuring during 0AM to 6AM

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China