Mobile Health and Wearable Devices for Diabetes Complication Management

NCT ID: NCT07129148

Last Updated: 2025-08-19

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2027-10-01

Brief Summary

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The value of intelligent lifestyle intervention for T2D and its complications has been initially explored, but evidence-based support for the effectiveness of related AI risk prediction models and intervention models remains to be confirmed. The primary objective of this study is to verify the effectiveness of an AI model for predicting the risk of T2D complications based on phenotype, laboratory indicators and wearable device indicators, and to explore the effect and applicability of an intelligent lifestyle intervention model combining wearable devices and smartphones in preventing T2D complications.

Detailed Description

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Conditions

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Diabetes Mellitus Type 2 Diabetes Mellitus Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control: Traditional Control

Adopt classic doctor-patient interaction management; receive diet and exercise education upon enrollment, self-monitor blood glucose at home and keep a diary.

Group Type OTHER

Device: No specific devices

Intervention Type OTHER

Routine doctor-patient interaction.

Experimental: Wearable Devices + Data Management Platform

On the basis of classic management, wear CGM , load CGM management software, and monitor health data in real time via mobile software.

Group Type OTHER

Device: CGM,CGM management platform

Intervention Type OTHER

Wearable monitoring + CGM management platform-assisted administration

Experimental:WeChat mini-program Smart Management

On the basis of classic management, use the "Professor Tang" WeChat mini-program for blood glucose recording and diet/exercise management.

Group Type OTHER

Device: "Professor Tang" WeChat Mini-program

Intervention Type OTHER

Mini-program-assisted health management

Experimental:Wearable Devices + WeChat mini-program Management

On the basis of classic management, wear CGM or smartbands , and use the "Professor Tang" WeChat mini-program simultaneously for real-time data monitoring and personalized recommendations.

Group Type OTHER

Device: CGM, Smart Bracelet, "Professor Tang" WeChat Mini-program

Intervention Type OTHER

Wearable monitoring + mini-program integrated management

Interventions

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Device: No specific devices

Routine doctor-patient interaction.

Intervention Type OTHER

Device: CGM,CGM management platform

Wearable monitoring + CGM management platform-assisted administration

Intervention Type OTHER

Device: "Professor Tang" WeChat Mini-program

Mini-program-assisted health management

Intervention Type OTHER

Device: CGM, Smart Bracelet, "Professor Tang" WeChat Mini-program

Wearable monitoring + mini-program integrated management

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Confirmed diagnosis of Type 2 Diabetes;
2. Aged ≥ 18 years;
3. Able to accept the diabetes management model with AI-assisted management and wearable device monitoring;
4. Able to provide complete lifestyle records, including medical history, medication status, diet, exercise, etc.;
5. Fully understand the purpose, nature, and methods of the study, voluntarily participate in this study, accept a 3-month follow-up, and sign the informed consent form.

Exclusion Criteria

1. Having severe mental illness or language barriers;
2. Suffering from malignant tumors;
3. Pregnant or lactating women;
4. Suspected active infections (such as active pulmonary tuberculosis, pneumonia, etc.);
5. Severe hepatic and renal insufficiency (alanine transaminase and/or aspartate transaminase \> 3 times the upper limit of normal; estimated glomerular filtration rate \< 15 mL/min/1.73 m²);
6. A history of definite major adverse cardiovascular events and/or revascularization and/or intravenous thrombolysis and/or endovascular thrombectomy;
7. Uncontrolled hyperthyroidism or hypothyroidism, pituitary-adrenal dysfunction, or other endocrine diseases;
8. Alcoholism or drug addiction;
9. Receiving insulin therapy;
10. Unable to accept new comprehensive intervention technologies for various reasons (such as personal beliefs, economic factors, etc.).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Hospital of China Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role collaborator

Tianjin Medical University Chu Hsien-I Memorial Hospital

UNKNOWN

Sponsor Role collaborator

Shanghai 6th People's Hospital

OTHER

Sponsor Role collaborator

Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus

UNKNOWN

Sponsor Role collaborator

Sinocare

INDUSTRY

Sponsor Role collaborator

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Second Xiangya Hospital of Central South University

Changsha, , China

Site Status

Countries

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China

Central Contacts

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HouDe Zhou, Prof.

Role: CONTACT

86-0731-85292223

Other Identifiers

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LYEC2024-0331

Identifier Type: -

Identifier Source: org_study_id

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