Therapeutic Efficacy and Safety Evaluation of AI in the Management of Diabetes: A RCT Trial

Launched by THE FIRST HOSPITAL OF JILIN UNIVERSITY · Apr 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how effective a new artificial intelligence (AI) program can be in helping people manage their type 2 diabetes. The goal is to see if using this AI technology can improve blood sugar levels (measured by HbA1c and other blood glucose tests) compared to standard diabetes care. Participants in the trial will use a special diabetes app on their smartphones, which will connect to a glucometer (a device that measures blood sugar) and an exercise bracelet. The app will track their health data and give personalized advice about medication, diet, and exercise based on the information it collects.

To be eligible for this trial, participants should be between 18 and 70 years old, diagnosed with type 2 diabetes for more than a year, and have specific blood sugar levels. They should also be comfortable using smartphones and willing to use the digital health platform. Throughout the study, participants will have regular check-ins with healthcare providers every three months, and both the AI group and the standard care group will receive help with managing their diabetes. This trial aims to find out if the AI approach leads to better health outcomes for people with diabetes.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria：
• • Age: ≥18 years，\<70 years;
• • Diagnosed with type 2 diabetes for \>1 year;
• • 7.0% \<HbA1c \<10%;
• • 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.