Evaluation of the Therapeutic Efficacy and Safety of Artificial Intelligence-based Decision-making Technology in the Integrated Management of Diabetes Mellitus: a Longitudinal, Open-labeled, Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Methods: For the AI Intervention group, the patients will be trained to independently use the diabetes telemedicine platform application. Each patient will be equipped with a glucometer and exercise bracelet, and the data will be automatically transmitted to the medical server via Bluetooth. The healthcare platform will analyze the uploaded data and provide feedback suggestions on medication, diet, and exercise automatically. The platform will also monitor the medical and lifestyle data of the patients every two weeks, offer feedback based on the analyses, and remind the patient to adhere to the self-management protocol based on the platform. The platform is a digitally integrated healthcare platform that patients can use independently without the need for monitoring and assistance by healthcare professionals. The glucometer and pedometer bracelet will automatically connect to the platform through Bluetooth. The patient lab sheet identification and structured conversion system, AI for food picture identification and calorie calculation systems, and the AI decision-making system are on the cloud server. Patients upload image information, such as lab sheets and meal pictures, through the patient's diabetes mobile health system, and the cloud platform intelligently analyzes the patient's disease, medication, and daily life status to develop personalized solutions according to individual control goals. Free outpatient visits will be provided to both the intervention and control groups every twelve weeks. For the conventional treatment group, patients will receive a free blood glucometer and will have regular outpatient appointments. There is no limit to the number of outpatient visits; however, they are required to regularly monitor and record their blood glucose, diet, and exercise data to ensure that the medical team objectively conduct their diagnosis and treatment activities. The medical team will provide free outpatient visits every 12 weeks, along with advice on medication, diet, and exercise based on the individual's blood glucose level. Expected results: A significant difference in HbA1c change from baseline to 48 weeks and improved FPG and 2-hour postprandial blood glucose levels in the AI intervention group were observed.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age: ≥18 years,≤75 years;

• Diagnosed with type 2 diabetes for ≥1 year;

• 7.0% ≤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.

Locations
Other Locations
China
The First Hospital of Jilin University
RECRUITING
Changchun
Contact Information
Primary
Chenglin Sun, Doctor
clsun213@163.com
+86 13944855718
Time Frame
Start Date: 2025-06-15
Estimated Completion Date: 2026-12
Participants
Target number of participants: 400
Treatments
Experimental: Artificial Intelligence Intervention Group
The patients will be trained to independently use the diabetes telemedicine platform application. Each patient will be equipped with a glucometer and exercise bracelet, and the data will be automatically transmitted to the medical server via Bluetooth. The healthcare platform will analyze the uploaded data and provide feedback suggestions on medication, diet, and exercise automatically. The platform will also monitor the medical and lifestyle data of the patients every two weeks,offer feedback based on the analyses, and remind the patient to adhere to the self-management protocol based on the platform. Free outpatient visits will be provided to both the intervention and control groups every twelve weeks.
Active_comparator: Conventional Treatment Group
Patients in the control group will receive a free blood glucometer and will have regular outpatient appointments every 12 weeks..
Related Therapeutic Areas
Sponsors
Leads: The First Hospital of Jilin University

This content was sourced from clinicaltrials.gov