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NCT Number: NCT06957093

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

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Key information

Conditions

Diabetes Mellitus Type 2 (T2DM) Artificial Intelligence (AI) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location status: Recruiting

Location contact

Sun

CONTACT

[email protected]

+8688782075

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Artificial intelligence

Other

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.

Routine diagnosis and treatment group for diabetes

Other

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.

Primary outcomes

  1. HbA1c

    Time frame: 48weeks

    Change From Baseline in HbA1c levels at 24 and 48 Weeks

  2. Fasting Blood Glucose (FBG)

    Time frame: 48 weeks

    Change from baseline in mean fasting blood glucose at 48 weeks

  3. 2-hour Postprandial Blood Glucose (2hPPG)

    Time frame: 48 weeks

    Change from baseline in mean 2-hour postprandial blood glucose at 48 weeks

  4. Hypoglycemic events

    Time frame: 48 weeks

    Number of hypoglycemic events from baseline to 48 weeks

Secondary outcomes

  1. Healthcare expenses

    Time frame: 48weeks

    Assess the monthly treatment costs from baseline to the 48 weeks

  2. Insulin and oral hypoglycemic agent dosing

    Time frame: 48 weeks

    Changes in oral medication and insulin dosage from baseline to week 48

  3. Serum lipids

    Time frame: 48 weeks

    Change From Baseline in serum lipids levels at 48 Weeks

  4. blood pressure

    Time frame: 48 weeks

    Change From Baseline in blood pressure at 48 Weeks

  5. BMI

    Time frame: 48 weeks

    Weight in kilograms, height in meters, weight and height will be combined to report BMI in kg/m^²

  6. body weight

    Time frame: 48weeks

    weight in kilograms

  7. Fasting C-peptide level

    Time frame: 48weeks

    Change From Baseline in fasting C-peptide level at 6 Weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Chenglin Sun, Doctor

CONTACT

[email protected]

+86 13944855718

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 4, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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