FreeStyle Libre Monitoring in T2DM

NCT05597293 | Completed DMC FDA Device

• 1 other identifier: 301630
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in the Diabetes Quality of Life (DQOL) score

  12 weeks

Study Arms (2)

FreeStyle Libe 2

ACTIVE COMPARATOR

Participants in this group will wear the FreeStyle Libre 2 device

Device: Glucose monitoring using FreeStyle Libre 2

FreeStyle Libre pro iQ

ACTIVE COMPARATOR

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

Device: Glucose monitoring using FreeStyle Libre pro iQ

Interventions

Glucose monitoring using FreeStyle Libre 2 DEVICE

Glucose monitoring in patients with type 2 diabetes using FreeStyle Libre 2

FreeStyle Libe 2

Glucose monitoring using FreeStyle Libre pro iQ DEVICE

Glucose monitoring in patients with type 2 diabetes using FreeStyle Libre pro iQ

FreeStyle Libre pro iQ

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hull: lead

Study Sites (1)

Hull University Teaching Hospitals NHS Trust, Academic diabetes, Endocrinology and metabolism

Hull, HU32RW, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 30291106 BACKGROUND

• 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.

  PMID: 32669277 BACKGROUND

• 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.

  PMID: 28137708 BACKGROUND

Study Officials

• Thozhukat Sathyapalan, FRCP,FACP

  University of Hull

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 28, 2022
• Study Start: February 27, 2023
• Primary Completion: March 11, 2024
• Study Completion: May 2, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)