AI-guided app to help manage type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial randomizes adults with type 2 diabetes to an AI-supported telemedicine platform versus routine care. Participants in the AI arm will be trained to use a smartphone app connected by Bluetooth to a glucometer and an activity bracelet so data are automatically uploaded to a medical server. The platform analyzes glucose, activity, and lifestyle data every two weeks and provides automated feedback, reminders, and recommendations about medication, diet, and exercise. Clinical visits and lab tests including HbA1c are scheduled at baseline and every 12 weeks up to 48 weeks to compare glycemic outcomes between groups.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Hospital of Jilin University
  Changchun, Jilin, China Recruiting

Study contacts

• Principal investigator: Chenglin Sun, Doctor — The First Hospital of Jilin University
• Study coordinator: Chenglin Sun, Doctor
• Email: clsun213@163.com
• Phone: +86 13944855718

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.