Last reviewed · How we verify
NCT07291804
Efficacy and Safety of an Intelligent Insulin-Dosing Decision Support System for Glycemic Control in Patients With Type 2 Diabetes: A Randomized Controlled Study
NA trial testing Intelligent Insulin-Dosing Decision Support System in Diabetes Mellitus，Type 2 in 140 participants. Completed in 1 December 2025.
1 December 2025
Quick facts
| Lead sponsor | Third Affiliated Hospital, Sun Yat-Sen University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 140 |
| Start date | 1 March 2025 |
| Primary completion | 1 December 2025 |
| Estimated completion | 1 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Intelligent Insulin-Dosing Decision Support System
Conditions studied
- Diabetes Mellitus，Type 2 — all drugs for Diabetes Mellitus，Type 2 →
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Who can join
18 and older, any sex, with Diabetes Mellitus，Type 2. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07291804
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07291804 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Third Affiliated Hospital, Sun Yat-Sen University
- Last refreshed: 18 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07291804.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing