NCT05636007

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

December 2, 2022

Status Verified

November 1, 2022

Enrollment Period

7 months

First QC Date

November 22, 2022

Last Update Submit

November 22, 2022

Conditions

Hypodlycemia

Outcome Measures

Primary Outcomes (1)

  • nocturnal hypoglycemia

    hypoglycemia occuring during 0AM to 6AM

    8 months

Interventions

Huawei WatchDEVICE

pulse rate variability measured by a smartwatch

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

type 2 diabetes patients with continuous glucose monitoring

You may qualify if:

  • \. ≥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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510620, China

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 22, 2022

First Posted

December 2, 2022

Study Start

December 1, 2022

Primary Completion

July 1, 2023

Study Completion

August 1, 2023

Last Updated

December 2, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)