NCT06268808

Initiation of Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin, in Italy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Abbott Diabetes Care · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical study is to determine the impact of starting the use of the FreeStyle Libre 2 glucose monitoring system, over a three month period, on HbA1c in adults with type 2 diabetes treated with a basal insulin regimen.

Detailed description

This is a post-market, multi-centre, prospective, interventional single arm study in Italy. Participants will use the FreeStyle Libre 2 Flash Glucose Monitoring System, according to the labelling, to monitor their glucose for approximately 3 months. Additional therapies may be introduced, if clinically indicated, based on review of the participant's clinical data and in line with national guidance. HbA1c will be tested at the start and end of the study for primary endpoint analysis.

Conditions

• Type 2 Diabetes Treated With Insulin

Interventions

Type	Name	Description
DEVICE	FreeStyle Libre 2 Flash Glucose Monitoring System	Glucose sensors to be worn continuously for 3 months with data used to monitor and manage diabetes treatment and to inform lifestyle choices (diet and exercise)

Timeline

• Start date: 2024-07-19
• Primary completion: 2025-09-24
• Completion: 2025-09-24
• First posted: 2024-02-20
• Last updated: 2025-12-23

Locations

8 sites across 1 country: Italy