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 | Completed

• 3 other identifiers: RG-2025-025-022025A1515012706YHJH202404
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Insulin; Intelligent Decision Support System

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Change in HbA1c from Baseline to Week 12, measured from fasting venous blood samples using High-Performance Liquid Chromatography (HPLC).

  Baseline, Week 12

Secondary Outcomes (6)

• Fasting Plasma Glucose (FPG) (mmol/L)

  Baseline, Week 12

• 2-hour Postprandial Plasma Glucose (2h PPG) (mmol/L)

  Baseline, Week 12

• Hypoglycemic Events

  From Baseline to Week 12

• Psychological Insulin Resistance

  Baseline, Week 12

• Empowerment Ability

  Baseline, Week 12

Study Arms (2)

Control Group

NO INTERVENTION

The control group received standard usual care, which included standardized diabetes education on the first day and routine follow-up where physicians adjusted insulin doses based on FPG levels during scheduled outpatient visits at Weeks 4, 8, 12, and 24.

Intervention Group

EXPERIMENTAL

The intervention group received usual care plus a structured program based on empowerment theory and implemented via an intelligent mHealth platform. This platform provided personalized dose recommendations and supported real-time data transmission ; physicians reviewed and confirmed dose adjustments at Day 4, Weeks 1, 2, 4, 8, 12, and 24 , and from Week 13 onward, patients were gradually authorized to self-adjust insulin doses under remote supervision.

Device: Intelligent Insulin-Dosing Decision Support System

Interventions

Intelligent Insulin-Dosing Decision Support System DEVICE

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• had severe diabetes-related complications (e.g., cardiac, hepatic, cerebral, or renal insufficiency);
• were unable to participate in regular follow-ups;
• had communication or cognitive barriers;
• had diagnosed psychiatric disorders; or
• discontinued basal insulin therapy for non-glycaemic reasons.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Nurse

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: March 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)