NCT05924932

Effect of HCL Insulin Delivery System on Glycemic Control in Patients With T1D

Effect of an Artificial Pancreas System on Glycemic Control in Patients With Type 1 Diabetes

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Masaryk Hospital Usti nad Labem · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is compare the effect of hybrid closed loop system (HCL) for automatic insulin dosing treatment on the glycemic control of type 1 diabetes (T1D) in patient with different initial glycated hemoglobin.

Detailed description

Rationale for the Study: According to our hypothesis, even T1D patients with an initially optimal glucose level should benefit from this treatment method in the form of a reduction in glycemic variability. There are very few clinical studies from real practice in a larger group of patients.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	Tandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6	type of hybrid close loop insulin delivery system
DEVICE	MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4	type of hybrid close loop insulin delivery system

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-12-01
• Completion: 2024-05-01
• First posted: 2023-06-29
• Last updated: 2023-11-03

Locations

1 site across 1 country: Czechia

Regulatory

• FDA-regulated device study