FreeStyle Libre Monitoring in T2DM

Not Applicable

Completed

• Conditions: Type2diabetes
• Interventions: Device: Glucose monitoring using FreeStyle Libre 2; Device: Glucose monitoring using FreeStyle Libre pro iQ

• Registration Number: NCT05597293
• Lead Sponsor: University of Hull

Brief 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.

Study Timeline

• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-24
• Study First Posted: 2022-10-28
• Study Start: 2023-02-27
• Primary Completion: 2024-03-11
• Study Completion: 2024-05-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Males and females living with type 2 diabetes mellitus (T2DM) who are aged ≥ 18 and ≤ 75 years
• On one or more non-insulin glucose lowering agent(s)
• HbA1c ≥ 69 mmol/mol
• Able to provide written informed consent

Exclusion Criteria

• Participants with a life expectancy of less than 1 year
• Participants with cognitive dysfunction or neurological disorder, which will interfere with regular, flash glucose monitoring
• Participants with chronic kidney disease (CKD) with eGFR < 45ml/min/1.73m2 or decompensated liver disease or decompensated congestive cardiac failure
• Myocardial infarction in the preceding 3 months or if percutaneous coronary intervention planned in the next 6 months
• Participants on supra-physiological doses of steroids, for example, Prednisolone for the treatment of Rheumatoid arthritis
• Participants on active dialysis or planned for dialysis treatment during the study
• Currently participating in another device or drug study that could affect glucose measurements or management
• Women who are pregnant, breastfeeding or planning to become pregnant. Women should use a reliable form of contraception throughout the study
• Participants who are already using continuous glucose monitoring (CGM)
• Participants who have pacemakers, implanted cardioverter defibrillator devices or neurostimulators
• Participants with an allergy to medical grade adhesive
• A blood transfusion in the preceding 3 months or a planned blood transfusion during the course of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FreeStyle Libe 2	Glucose monitoring using FreeStyle Libre 2	Participants in this group will wear the FreeStyle Libre 2 device
FreeStyle Libre pro iQ	Glucose monitoring using FreeStyle Libre pro iQ	Participants in this arm will wear the FreeStyle Libre pro iQ device

Primary Outcome Measures

Name	Time	Method
Number of participants with a change in HbA1c of 5.5 mmol/mol or more	12 weeks	The number of participants with a change in HbA1c of 5.5 mmol/mol or more at the end of the study compared to baseline HbA1c

Secondary Outcome Measures

Name	Time	Method
Change in the Diabetes Quality of Life (DQOL) score	12 weeks	Change in Diabetes Quality of Life (DQOL) score from baseline to end of the study. The total scores range from 0 (lowest possible quality of life) to 100 (highest possible quality of life). Higher scores mean a better outcome

Trial Locations

Locations (1)

Hull University Teaching Hospitals NHS Trust, Academic diabetes, Endocrinology and metabolism; 🇬🇧 Hull, United Kingdom