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Efficacy and Safety of an Intelligent Insulin-Dosing Decision Support System for Glycemic Control in Patients With Type 2 Diabetes: A Randomized Controlled Study

NCT07291804 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-12-18

No results posted yet for this study

Summary

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

Conditions

  • Diabetes Mellitus，Type 2

Interventions

DEVICE

Intelligent Insulin-Dosing Decision Support System

This intelligent insulin dosing system for type 2 diabetes operates on an IoT platform. Its core function begins with a comprehensive assessment that integrates patient data and islet function indicators to stratify hypoglycemia risk, followed by generating an individualized initial insulin dose based on guidelines and the risk category. The system then continuously estimates the patient's dynamic insulin sensitivity using real-time streams of glucose and insulin data. Dose titration is executed in three structured phases: an initial phase (Day 3-14) with adjustments every 3 days based on daily glucose, a stable phase (Week 3-12) with weekly adjustments using tri-weekly data, and a long-term maintenance phase (Week 13-24) with weekly recommendations, where eligible patients can begin remote-supervised self-management.

Sponsors & Collaborators

  • Third Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07291804 on ClinicalTrials.gov