Health TrialsbyHealthPanel

Mobile Health and Wearable Devices for Diabetes Complication Management

ConditionsDiabetes Mellitus Type 2Diabetes Mellitus Complications
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Xiangya Hospital of Central South University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed diagnosis of Type 2 Diabetes;

Aged ≥ 18 years;

Able to accept the diabetes management model with AI-assisted management and wearable device monitoring;

Able to provide complete lifestyle records, including medical history, medication status, diet, exercise, etc.;

Disqualifiers

Having severe mental illness or language barriers;

Suffering from malignant tumors;

Pregnant or lactating women;

Suspected active infections (such as active pulmonary tuberculosis, pneumonia, etc.);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Device: No specific devices

    Other intervention

    Routine doctor-patient interaction.

  • Device: CGM,CGM management platform

    Other intervention

    Wearable monitoring + CGM management platform-assisted administration

  • Device: "Professor Tang" WeChat Mini-program

    Other intervention

    Mini-program-assisted health management

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

    Other intervention

    Wearable monitoring + mini-program integrated management

Treatment groups

6,000 Participants
are divided into 4 treatment groups
Group A: Control: Traditional ControlOther 1 intervention
Group B: Experimental: Wearable Devices + Data Management PlatformOther 1 intervention
Group C: Experimental:WeChat mini-program Smart ManagementOther 1 intervention
Group D: Experimental:Wearable Devices + WeChat mini-program ManagementOther 1 intervention

Trial outcomes

Primary outcomes

1

HbA1c

Between-group differences in HbA1c change (from Central Lab)

Time frame
Baseline, 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Xiangya Hospital of Central South University

Lead sponsor

First Hospital of China Medical University

Collaborator

The First Affiliated Hospital with Nanjing Medical University

Collaborator

First Affiliated Hospital of Harbin Medical University

Collaborator

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

Collaborator

First Affiliated Hospital of Kunming Medical University

Collaborator

Tianjin Medical University

Collaborator

Shanghai 6th People's Hospital

Collaborator

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

Collaborator

Sinocare

Collaborator

Source ClinicalTrials.gov
Apply now