FreeStyle Libre Monitoring in T2DM

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type2diabetes

Intervention / Treatment
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* Device: Glucose monitoring using FreeStyle Libre 2
* Device: Glucose monitoring using FreeStyle Libre pro iQ


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FreeStyle Libe 2<br>Participants in this group will wear the FreeStyle Libre 2 device | Device: Glucose monitoring using FreeStyle Libre 2<br>* Glucose monitoring in patients with type 2 diabetes using FreeStyle Libre 2<br>|
| Active Comparator: FreeStyle Libre pro iQ<br>Participants in this arm will wear the FreeStyle Libre pro iQ device | Device: Glucose monitoring using FreeStyle Libre pro iQ<br>* Glucose monitoring in patients with type 2 diabetes using FreeStyle Libre pro iQ<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with a change in HbA1c of 5.5 mmol/mol or more | 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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Diabetes Quality of Life (DQOL) score | 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 | 12 weeks |