Therapeutic Efficacy and Safety Evaluation of AI in the Management of Diabetes: A RCT Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Hospital of Jilin University
About this trial
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.
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 criteria
This trial does not accept healthy volunteersQualifiers
Age: ≥18 years，≤75 years;
Diagnosed with type 2 diabetes for ≥1 year;
7.0% ≤HbA1c ≤11%;
Body mass index ≥18.5 kg/m2;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
artificial intelligence
Other interventionThe 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.
Routine diagnosis and treatment group for diabetes
Other interventionThere is no limit to the number of outpatient visits for the control group; however, they are required to regularly monitor and record their blood glucose, diet, and exercise data to ensure that the medical team (endocrinologist and nutritionist) objectively conducttheir 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.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Artificial Intelligence Intervention GroupExperimental treatment 1 intervention
Group B: Conventional Treatment GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
HbA1c
Change From Baseline in HbA1c levels at 24 and 48 Weeks
Time frame
48weeks2
Fasting Blood Glucose (FBG)
Change from baseline in mean fasting blood glucose at 48 weeks
Time frame
48 weeks3
2-hour Postprandial Blood Glucose (2hPPG)
Change from baseline in mean 2-hour postprandial blood glucose at 48 weeks
Time frame
48 weeks4
Hypoglycemic events
Number of hypoglycemic events from baseline to 48 weeks
Time frame
48 weeksSecondary outcomes
1
Healthcare expenses
Assess the monthly treatment costs from baseline to the 48 weeks
Time frame
48weeks2
Insulin and oral hypoglycemic agent dosing
Changes in oral medication and insulin dosage from baseline to week 48
Time frame
48 weeks3
Serum lipids
Change From Baseline in serum lipids levels at 48 Weeks
Time frame
48 weeks4
blood pressure
Change From Baseline in blood pressure at 48 Weeks
Time frame
48 weeksSponsors and contacts
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Source ClinicalTrials.gov