Mobile Health and Wearable Devices for Diabetes Complication Management

Central South University

Status: Not yet enrolling

Conditions: Diabetes Mellitus Complications; Diabetes Mellitus Type 2

Treatments: Other: Device: No specific devices; Other: Device: CGM,CGM management platform; Other: Device: "Professor Tang" WeChat Mini-program; Other: Device: CGM, Smart Bracelet, "Professor Tang" WeChat Mini-program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07129148

LYEC2024-0331

Details and patient eligibility

About

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.

Enrollment: 1,600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,600 participants in 4 patient groups

Control: Traditional Control

Other group

Description:

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

Treatment:

Other: Device: No specific devices

Experimental: Wearable Devices + Data Management Platform

Other group

Description:

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

Treatment:

Other: Device: CGM,CGM management platform

Experimental:WeChat mini-program Smart Management

Other group

Description:

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

Treatment:

Other: Device: "Professor Tang" WeChat Mini-program

Experimental:Wearable Devices + WeChat mini-program Management

Other group

Description:

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.

Treatment:

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