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Tests treatment safety and results for Diabetes Mellitus Type 2 (T2DM)
Official title Therapeutic Efficacy and Safety Evaluation of AI in the Management of Diabetes: A RCT Trial
ClinicalTrials.gov ID: NCT06957093
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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;
You likely can't join if
- 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...
- 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;
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Changchun, Jilin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changchun, Jilin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.