Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07129148

Mobile Health and Wearable Devices for Diabetes Complication Management

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.;
  • 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

  • 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.);
  • 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);
  • A history of definite major adverse cardiovascular events and/or revascularization and/or intravenous thrombolysis and/or endovascular thrombectomy;
  • Uncontrolled hyperthyroidism or hypothyroidism, pituitary-adrenal dysfunction, or other endocrine diseases;
  • Alcoholism or drug addiction;
  • Receiving insulin therapy;
  • Unable to accept new comprehensive intervention technologies for various reasons (such as personal beliefs, economic factors, etc.).

Treatment and study plan

Device: No specific devices

Other

Routine doctor-patient interaction.

Device: CGM,CGM management platform

Other

Wearable monitoring + CGM management platform-assisted administration

Device: "Professor Tang" WeChat Mini-program

Other

Mini-program-assisted health management

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

Other

Wearable monitoring + mini-program integrated management

Primary outcomes

  1. HbA1c

    Time frame: Baseline, 1 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

HouDe Zhou, Prof.

CONTACT

[email protected]

86-0731-85292223

Sponsors and collaborators

Lead sponsor

Second Xiangya Hospital of Central South University

Other

Collaborators

  • First Affiliated Hospital of Harbin Medical University
  • First Affiliated Hospital of Kunming Medical University
  • First Hospital of China Medical University
  • Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus
  • Shanghai 6th People's Hospital
  • Sinocare
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • The First Affiliated Hospital with Nanjing Medical University
  • Tianjin Medical University

Registry information

Official study title

Study on the Applicability of New Technologies for Diabetes Complication Management Based on Mobile Health and Wearable Devices

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 19, 2025
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.