NCT07291804Completed
Efficacy and Safety of an Intelligent Insulin-Dosing Decision Support System for Glycemic Control in Patients With Type 2 Diabetes: A Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
The goal of this clinical trial is to learn if an intelligent insulin-dosing decision support system can improve glycemic control in adults with type 2 diabetes who are starting basal insulin therapy. The trial also aims to evaluate the safety of using this system for insulin dose adjustment. The main questions it aims to answer are: * Does the intelligent decision support system improve fasting glucose, postprandial glucose, and HbA1c? * Does the system provide safe insulin titration without raising hypoglycemia risk and improve empowerment, self-management, and insulin-related attitudes? Researchers will compare the intelligent insulin-dosing decision support system with usual care to see if the system leads to more effective and safer insulin titration. Participants will: * Upload blood glucose data using a smart glucometer connected to a mobile health platform * Receive basal insulin therapy with ongoing dose adjustments Intervention group: use the intelligent decision support system that provides algorithm-based insulin dose recommendations with remote monitoring and guidance Control group: receive standard diabetes education and routine outpatient insulin titration
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 140 (actual)
- First submitted
- 5 Dec 2025
- Start date
- 1 Mar 2025
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Diseases
- Type 2 diabetes
- NCT number
- NCT07291804
What you commit to
- Study type: Interventional
- Participants enrolled: 140
- From 1 Mar 2025 to the primary completion date, 1 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- discontinued basal insulin therapy for non-glycaemic reasons.
Other illness
- had severe diabetes-related complications (e.g., cardiac, hepatic, cerebral, or renal insufficiency);
- had diagnosed psychiatric disorders; or
Other
- were unable to participate in regular follow-ups;
- had communication or cognitive barriers;
Who the study is looking for
- were diagnosed with T2DM according to the Guideline for the Prevention and Treatment of Diabetes Mellitus in China (2024 edition);
- were prescribed basal insulin therapy for the first time;
- were aged 18 years or older;
- voluntarily participated in this study; and
- had access to mobile devices and the internet.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Third Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.