Combining Wearable Technology to Crate Internet+Digital Hospital-remote Home Type 2 Diabetes Follow-up Management Mode

NCT ID: NCT04973644

Last Updated: 2025-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-21

Study Completion Date

2022-07-23

Brief Summary

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This study intends to combining wearable technology to crate Internet+Digital Hospital-remote Home Type 2 Diabetes follow-up management mode.To preliminarily explore compared with the traditional medical treatment mode, whether the new management mode of DM can improve the management objectives and patient satisfaction of T2DM and reduce medical costs. The study provides a powerful reference for establishing corresponding platforms and promoting such models at the government management level in the future.

Detailed Description

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Background:The prevalence of T2DM in Chinese adults has exceeded 10%, and the prevalence of abnormal glucose metabolism has exceeded 40% in people older than 18 years. This will lead to a significant increase in the prevalence of DM complications in the next decade, and the disability and death caused by complications will also seriously affect the quality of life of patients and bring a huge social and economic burden.This randomized controlled trial intends to combining wearable technology to crate Internet+Digital Hospital-remote Home T2DM follow-up management mode.To preliminarily explore compared with the traditional medical treatment mode, whether the new management mode of DM can improve the management objectives and patient satisfaction of T2DM and reduce medical costs. The study provides a powerful reference for establishing corresponding platforms and promoting such models at the government management level in the future.

Methods:The study was a parallel-group, randomised, controlled trial. the number of cases planned to be included in 200 cases. Participants were randomly assigned to the intervention or control group.The intervention group receives Internet + Digital Hospital-remote home management mode,including remote monitoring devices+Internet management platform, dietary recommendations, exercise supervision, web education, information pushing, doctor-patient interaction, etc.The control group receives the traditional management mode, including routine dietary and exercise recommendations, education as well as monitor in the clinic.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Internet + Digital Hospital-remote home management mode

Remote monitoring devices+Internet management platform, dietary recommendations, exercise supervision, web education, information pushing, doctor-patient interaction.

Group Type EXPERIMENTAL

Remote monitoring devices+Internet management platform

Intervention Type DEVICE

Remote monitoring devices collects blood glucose, total cholesterol, serum ketones and serum uric acid,then upload data to the platform.

the traditional management mode

Routine dietary and exercise recommendations, education as well as monitor in the clinic.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Remote monitoring devices+Internet management platform

Remote monitoring devices collects blood glucose, total cholesterol, serum ketones and serum uric acid,then upload data to the platform.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with type 2 diabetes according to the World Health Organization criteria;
* Aged between 18 and 70 years;
* Glycosylated haemoglobin (HbA1C%) between 7% and 9%.

Exclusion Criteria

* Type 1 diabetes;
* Gestational diabetes;
* Other special types of diabetes;
* Moderate-severe insufficiency of heart , liver, kidney and lung;
* Complicated with acute disease or stress status.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role lead

Responsible Party

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YunFeng Shen

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Second Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, China

Site Status

Countries

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China

References

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Peng P, Shen Y, Xiong H. Wearable monitoring device based on an internet management platform improves metabolic parameters in type 2 diabetes patients: a prospective pilot study. Postgrad Med. 2024 Jun;136(5):523-532. doi: 10.1080/00325481.2024.2366156. Epub 2024 Jun 13.

Reference Type DERIVED
PMID: 38870076 (View on PubMed)

Other Identifiers

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DM202106

Identifier Type: -

Identifier Source: org_study_id

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