NCT06741943

Evaluating an Insulin Pump for Time in Range (TIR) in Patients with Type 1 Diabetes

A Prospective, Multicenter, Open-label Study Evaluating an Insulin Pump (model: AR-B200A) for Time in Range (TIR) in Patients with Type 1 Diabetes

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tao Yuan，MD · Academic / Other
• Sex: All
• Age: 8 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Diabetes mellitus is a metabolic disorder caused by genetic, environmental changes, mental health issues, immune disorders, and other factors. It may occur with or without insulin resistance, insulin secretion defect, or impaired biological function of insulin. The condition is characterized by chronic hyperglycemia and targeted damage to multiple systems and organs. Insulin pump therapy is an advanced method for managing diabetes that mimics the natural secretion of insulin by providing continuous delivery to diabetic patients. Compared to traditional multiple injections, the use of an insulin pump reduces the number of injections required and improves patient compliance and treatment convenience. The medical team can customize the insulin pump treatment based on each patient's specific situation in order to achieve optimal blood sugar control and effectively reduce the risk of complications. In recent years, there has been significant attention given to glucose-in-target time (TIR), which refers to the amount of time blood sugar levels are within a range of 3.9 to 10.0 mmol/L in non-pregnant adults measured either as minutes or as a percentage (%). This clinical trial aims to collect data on using an insulin pump (Model: AR-B200A) combined with a scanning glucose monitoring system (Model: FreeStyle Libre, 20163072472) for continuous subcutaneous insulin infusion in type 1 diabetes patients in order to provide reference for related clinical applications.

Conditions

• Type 1 Diabetes Mellitus
• Insulin Pump
• Time in Range

Interventions

Type	Name	Description
DEVICE	insulin pump (model: AR-B200A)	USE insulin pump (model: AR-B200A) and continuous glucose monitoring (FreeStyle Libre)

Timeline

• Start date: 2024-12-11
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-12-19
• Last updated: 2024-12-19

Locations

1 site across 1 country: China