FreeStyle Libre Monitoring in T2DM

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type2diabetes
• Intervention / Treatment: Device: Glucose monitoring using FreeStyle Libre 2; Device: Glucose monitoring using FreeStyle Libre pro iQ

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chair in Academic Diabetes, Endocrinology and Metabolism; Phone Number: +441482675387; Email: thozhukat.sathyapalan@hyms.ac.uk

Study Locations

• United Kingdom
  • Hull, United Kingdom, HU32RW
    • Recruiting
    • Hull University Teaching Hospitals NHS Trust, Academic diabetes, Endocrinology and metabolism
    • Contact: Thozhukat Sathyapalan, MD FRCP; Phone Number: +441482675312; Email: thozhukat.sathyaplan@hyms.ac.uk
    • Contact: Najeeb Shah, MBBS, MRCP; Phone Number: +441482675387; Email: hyns17@hyms.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Hull
• Investigators: Principal Investigator: Thozhukat Sathyapalan, FRCP,FACP, University of Hull

Publications and helpful links

General Publications

• Edge J, Acerini C, Campbell F, Hamilton-Shield J, Moudiotis C, Rahman S, Randell T, Smith A, Trevelyan N. An alternative sensor-based method for glucose monitoring in children and young people with diabetes. Arch Dis Child. 2017 Jun;102(6):543-549. doi: 10.1136/archdischild-2016-311530. Epub 2017 Jan 30.
• Davies MJ, D'Alessio DA, Fradkin J, Kernan WN, Mathieu C, Mingrone G, Rossing P, Tsapas A, Wexler DJ, Buse JB. Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018 Dec;41(12):2669-2701. doi: 10.2337/dci18-0033. Epub 2018 Oct 4.
• Deshmukh H, Wilmot EG, Gregory R, Barnes D, Narendran P, Saunders S, Furlong N, Kamaruddin S, Banatwalla R, Herring R, Kilvert A, Patmore J, Walton C, Ryder REJ, Sathyapalan T. Effect of Flash Glucose Monitoring on Glycemic Control, Hypoglycemia, Diabetes-Related Distress, and Resource Utilization in the Association of British Clinical Diabetologists (ABCD) Nationwide Audit. Diabetes Care. 2020 Sep;43(9):2153-2160. doi: 10.2337/dc20-0738. Epub 2020 Jul 15.

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 301630

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes