Status:
RECRUITING
Therapeutic Efficacy and Safety Evaluation of AI in the Management of Diabetes: A RCT Trial
Lead Sponsor:
The First Hospital of Jilin University
Conditions:
Diabetes Mellitus Type 2 (T2DM)
Artificial Intelligence (AI)
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Purpose: To evaluate the efficacy of artificial intelligence (AI)-based decision-making technology in managing glycated hemoglobin (HbA1c) and blood glucose levels compared to the control group. Meth...
Detailed Description
Follow-up Plan:: Visit 1(-4W\~-1W): Obtain the written informed consents of the patients, conduct the demographic survey, medical record survey, drug history investigation, subject compliance investi...
Eligibility Criteria
Inclusion
- Inclusion Criteria：
- Age: ≥18 years，≤75 years;
- Diagnosed with type 2 diabetes for ≥1 year;
- 0% ≤HbA1c ≤11%;
- Body mass index ≥18.5 kg/m2;
- Proficient ability to use smart phones;
- Agreed to utilize a digital integrated healthcare platform for diabetes care and research;
- Informed consents are obtained from the participants.
- Exclusion Criteria:
- Presence of other types of diabetes, such as type 1 diabetes and gestational diabetes;
- Severe diabetic complications;
- Medical history of chronic liver diseases, including hemochromatosis, hepatocellular carcinoma, autoimmune liver disease, cirrhosis, viral hepatitis (including hepatitis A, B, and C), or hepatolenticular degeneration;
- Kidney injury (serum creatinine ≥1.5 times the upper limit of the reference) ; Serum ALT and AST levels elevated \>2-fold;
- Medical history of mental disorders, such asschizophrenia, depression, or bipolar affective disorder;
- Excessive alcohol intake or drug abuse in the past 3 months;
- Use of medications affecting glucose metabolism, such as corticosteroids or ·consumption of immunosuppressive and anti-obesity medications in the past 3 months;
- Pregnancy, planning for pregnancy, or lactation; or any other conditions unsuitable for trial participation;
- Participatingor plan to participate in other clinical trials; and other cases that are inappropriate to participate.
Exclusion
Key Trial Info
Start Date :
June 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06957093
Start Date
June 15 2025
End Date
December 1 2026
Last Update
December 9 2025
Active Locations (1)
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1
The First Hospital of Jilin University
Changchun, Jilin, China, 130000