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

December 2, 2025 updated by: The First Hospital of Jilin University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 investigation, vital signs checkup, laboratory tests, imaging, and other instrument examinations, as well as evaluate the comorbidities of diabetes.

Visit 2 (D0): Educate the intervention group operating the platform system, evaluating diabetic hypoglycemia events, enhancing patients' self-management abilities, and knowledge mastery. Lab tests will be conducted at 12-week intervals, including Visit 3 (12W), Visit 4 (24W) or Visit 5 (36W), and Visit 6 (48W).

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chenglin Sun, Doctor
  • Phone Number: +86 13944855718
  • Email: clsun213@163.com

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130000
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria：

  • 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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: artificial intelligence
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.
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..
Other: Routine diagnosis and treatment group for diabetes
There 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 48weeks
Change From Baseline in HbA1c levels at 24 and 48 Weeks
48weeks
Fasting Blood Glucose (FBG)
Time Frame: 48 weeks
Change from baseline in mean fasting blood glucose at 48 weeks
48 weeks
2-hour Postprandial Blood Glucose (2hPPG)
Time Frame: 48 weeks
Change from baseline in mean 2-hour postprandial blood glucose at 48 weeks
48 weeks
Hypoglycemic events
Time Frame: 48 weeks
Number of hypoglycemic events from baseline to 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthcare expenses
Time Frame: 48weeks
Assess the monthly treatment costs from baseline to the 48 weeks
48weeks
Insulin and oral hypoglycemic agent dosing
Time Frame: 48 weeks
Changes in oral medication and insulin dosage from baseline to week 48
48 weeks
Serum lipids
Time Frame: 48 weeks
Change From Baseline in serum lipids levels at 48 Weeks
48 weeks
blood pressure
Time Frame: 48 weeks
Change From Baseline in blood pressure at 48 Weeks
48 weeks
BMI
Time Frame: 48 weeks
Weight in kilograms, height in meters, weight and height will be combined to report BMI in kg/m^²
48 weeks
body weight
Time Frame: 48weeks
weight in kilograms
48weeks
Fasting C-peptide level
Time Frame: 48weeks
Change From Baseline in fasting C-peptide level at 6 Weeks
48weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Hospital of Jilin University

Investigators

  • Principal Investigator: Chenglin Sun, Doctor, The First Hospital of Jilin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 17, 2025

First Submitted That Met QC Criteria

April 25, 2025

First Posted (Actual)

May 4, 2025

Study Record Updates

Last Update Posted (Estimated)

December 9, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K2024283

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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