FreeStyle Libre Monitoring in T2DM

University of Hull

Status: Completed

Conditions: Type2diabetes

Treatments: Device: Glucose monitoring using FreeStyle Libre 2; Device: Glucose monitoring using FreeStyle Libre pro iQ

Study type: Interventional

Funder types: Other

Identifiers

NCT05597293

301630

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

FreeStyle Libe 2

Active Comparator group

Description:

Participants in this group will wear the FreeStyle Libre 2 device

Treatment:

Device: Glucose monitoring using FreeStyle Libre 2

FreeStyle Libre pro iQ

Active Comparator group

Description:

Participants in this arm will wear the FreeStyle Libre pro iQ device

Treatment:

Device: Glucose monitoring using FreeStyle Libre pro iQ