Clinical trial NCT05597293: FreeStyle Libre Monitoring in T2DM
Official title: Effect of Introduction of FreeStyle Libre Monitoring on Glycaemic Control in People with Type 2 Diabetes Mellitus (T2DM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2diabetes
Lead sponsor: University of Hull
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with a change in HbA1c of 5.5 mmol/mol or more
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in the Diabetes Quality of Life (DQOL) score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust, Academic diabetes, Endocrinology and metabolism
Study officials:
affiliation: University of Hull
name: Thozhukat Sathyapalan, FRCP,FACP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.