NCT05597293

FreeStyle Libre Monitoring in T2DM

Effect of Introduction of FreeStyle Libre Monitoring on Glycaemic Control in People with Type 2 Diabetes Mellitus (T2DM)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Hull · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if blood sugar monitoring using a FreeStyle Libre device can improve overall Diabetes control in people with Type 2 Diabetes. The main questions it aims to answer are: * What is the effect of monitoring using the FreeStyle Libre device for a period of 12 weeks on the blood sugar control of people with Type 2 Diabetes? * Can monitoring using the FreeStyle Libre device improve the quality of life of people with Type 2 diabetes? Participants will be asked to wear one of two brands of FreeStyle Libre devices. In one group, participants will have 3 visits, while those in the second group, they will have 4 visits. Researchers will compare the improvement in the sugar control for the individuals but also compare between the 2 groups.

Detailed description

This is a prospective, randomised, open-labelled, non-CTIMP, pilot study. Participants meeting the inclusion criteria and who have consented to participate in the study will be randomised on a 1:1 ratio to receive either Libre 2 or Libre pro iQ. Randomisation will be carried out using an online randomisation tool to allocate a participant to a treatment group. The study will consist of three visits (Libre 2 arm) and four visits (Libre pro iQ arm). The study will be completed over 12 weeks.

Conditions

• Type2diabetes

Interventions

Type	Name	Description
DEVICE	Glucose monitoring using FreeStyle Libre 2	Glucose monitoring in patients with type 2 diabetes using FreeStyle Libre 2
DEVICE	Glucose monitoring using FreeStyle Libre pro iQ	Glucose monitoring in patients with type 2 diabetes using FreeStyle Libre pro iQ

Timeline

• Start date: 2023-02-27
• Primary completion: 2024-03-11
• Completion: 2024-05-02
• First posted: 2022-10-28
• Last updated: 2024-12-24

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study