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"Research and development, demonstration and promotion of key technologies for prevention and control of diabetes and complications based on artificial intelligence" ——multicenter clinical study

"Research and development, demonstration and promotion of key technologies for prevention and control of diabetes and complications based on artificial intelligence" ——multicenter clinical study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088036
Enrollment
Unknown
Registered
2024-08-09
Start date
2023-04-24
Completion date
Unknown
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Interventions

Artificial Intelligence Technology Intervention Group:In addition to receiving conventional offline diabetes education, participants will be provided with an AI Diabetes Management Assistant (mini-pro
intelligent health goal creation, where AI algorithms recommend health goals and assess and monitor progress
intelligent dietary intervention, which uses a knowledge-based dietary recommendation model to generate personalized meal plans
intelligent exercise intervention that evaluates the type and intensity of physical activity and recommends the most suitable exercise plans
intelligent blood glucose and blood pressure monitoring, providing real-time monitoring and generating reports and trend charts
intelligent user profiling, which uses AI technology to create detailed user profiles for personalized education recommendations
intelligent personalized education based on a diabetes knowledge graph to offer individualized educational models
and intelligent follow-up management that automatically generates follow-up plans, sends follow-up reminders and questionnaires, and tracks follow-up feedback.
Human coaching intervention group:In addition to receiving conventional offline diabetes education, participants can also use an interactive mini-program that contains static educational information r

Sponsors

The First Affiliated Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age between 20 and 70 years. 2.Proficiency in Mandarin. 3.Possession of a smartphone and the ability to download WeChat. 4.Ability to read, write, and send messages using a smartphone (e.g., sending messages via WeChat or other similar mobile applications). 5.Informed consent and voluntary participation in the trial. 6.Diagnosis of type 2 diabetes mellitus according to the 1999 World Health Organization (WHO) criteria. 7.Participants who control their blood glucose solely through lifestyle interventions or by using oral hypoglycemic agents, GLP-1 agonists, or non-insulin intensive regimens. 8.Overweight or obese. (1)Body Mass Index (BMI) = 24 kg/m². 9.No or only mild chronic microvascular complications. (1)Toronto Clinical Neuropathy Scoring System (DPN TCSS) score = 8 for peripheral neuropathy. (2)Fundus camera examination results showing non-proliferative diabetic retinopathy. (3)Diabetic kidney disease (DKD) test results with eGFR > 45 ml/min and UACR < 300 mg/g. (4)Diabetic foot Wagner grade 2 or below.

Exclusion criteria

Exclusion criteria: 1.Any condition expected to affect compliance and follow-up for 12 months. 2.Difficulty using a smartphone, specifically the inability to send messages using a smartphone. 3.Participation in other randomized controlled trials based on lifestyle behavior changes. 4.Current alcohol abuse or illegal drug use (excessive alcohol consumption is not an exclusion criterion as it is a potential target for behavior change). 5.Hospitalization or suffering from other acute severe conditions requiring immediate hospitalization. 6.Specialist or general practitioner estimates a life expectancy of less than 5 years due to related diseases. 7.Suffering from sexually transmitted diseases such as viral hepatitis, AIDS, or syphilis, and infectious diseases like active tuberculosis. 8.Diagnosed with cancer. 9.Diagnosed with lower limb arterial stenosis or occlusion

Design outcomes

Primary

MeasureTime frame
Fasting blood glucose, 2-hour post-meal blood glucose;glycated hemoglobin;Blood pressure;serum lipid level, total cholesterol(TC), triglyceride(TG), high density lipoprotein(HDL), low density lipoprotein(LDL);body mass index;Renal function indicators (Cr, eGFR and UACR);Classification of diabetic retinopathy;Classification of Diabetic neuropathy(TCSS score);Development of diabetic lower extremity arterial disease (ABI?Fontaine scale);Development of diabetic foot(Wagner grading);Changes in diabetes self-management ability (Summary of Diabetes Self-Care Activities-6);

Secondary

MeasureTime frame
Changes in patients' medical burden;Satisfaction evaluation of health management model;

Countries

China

Contacts

Public ContactSunjie Yan

The First Affiliated Hospital of Fujian Medical University

fjyansunjie@163.com+86 138 0501 5737

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026