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Intervention Effects of a Multimodal Knowledge-Enhanced Recommendation System on Type 2 Diabetes Mellitus Remission Management: A Prospective Randomized Controlled Trial

Knowledge-Enhanced and Multimodal Large Model-Driven Construction and Empirical Study of a Recommendation System for Type 2 Diabetes Mellitus Remission Management Programs

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102466
Enrollment
Unknown
Registered
2025-05-15
Start date
2025-05-20
Completion date
Unknown
Last updated
2025-05-19

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

Conditions

diabetes

Interventions

intervention group:The intervention group integrates the knowledge graph-based Diabetes Relief Solution Recommendation System (DRSRS) on the basis of SDPC, and realizes multi-dimensional intervention
support patients to upload real-time physiological indicators (blood glucose, blood pressure), lifestyle data (dietary records, length of exercise) and medication information, and generate visualized
set up an intelligent reminder function in combination with the individualized needs of the patient, push medication and blood glucose monitoring tips at regular intervals and dynamically optimize the
control group:The control group received the standard diabetes management program (SDPC), including routine medical services provided by community physicians, such as regular follow-up visits (every 3

Sponsors

Endocrine and Diabetes Center, Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Clinical diagnosis: meet the WHO or ADA diagnostic criteria for type 2 diabetes mellitus (meet any of the following): (1) Fasting blood glucose >=7.0 mmol/L; (2) 2-hour postprandial blood glucose >=11.1 mmol/L; (3)HbA1c>=6.5%; (4) Current HbA1c >=7.0% (poor glycemic control). 2. Demographic characteristics: (1) Age 18-75 years old; (2) Continuously residing in Nanjing for > = 1 year, and have no relocation plan in the next 2 years. 3. Technical adaptability: (1) Proficient in the use of smart phones (install the customized app of this study) and social tools such as WeChat (for health data synchronization and follow-up). 4. Treatment background: (1) No adjustment of insulin treatment regimen within 3 months prior to enrollment; (2) Not participating in other diabetes intervention trials. 5. Informed consent: (1) Voluntarily signed the informed consent form and promised to complete the 6-month follow-up.

Exclusion criteria

Exclusion criteria: 1. Diabetes classification and complications: (1) Type 1 diabetes, gestational diabetes or secondary diabetes (such as post-pancreatitis diabetes); (2) Complications of severe diabetes: 1) Diabetic nephropathy (eGFR<30 ml/min/1.73m²); 2) proliferative retinopathy; 3) NYHA Class III-IV heart failure. 2. Conflict between comorbidities and treatment: (1) Active malignant tumor or chemoradiotherapy in the past 6 months; (2) Long-term use of glucocorticoids or other drugs that affect blood glucose metabolism is required. 3. Cognitive and behavioral limitations: (1) Diagnosed Alzheimer's disease, severe cognitive impairment (MMSE score <18) or psychiatric illness (such as schizophrenia); (2) History of alcohol or drug dependence (affecting compliance). 4. Technical or language barriers: (1) Unable to complete the Chinese version of the electronic questionnaire filling or App operation training.

Design outcomes

Primary

MeasureTime frame
HbA1c change value;Diabetes remission rate;

Countries

China

Contacts

Public ContactDoudou Li

Endocrine and Diabetes Center, Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine

doudouli1983@163.com+86 139 2143 6968

Outcome results

None listed

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