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Completed

NCT Number: NCT05597293

FreeStyle Libre Monitoring in 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.

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Key information

Conditions

Type2diabetes

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hull, HU32RW, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucose monitoring using FreeStyle Libre 2

Device

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

Glucose monitoring using FreeStyle Libre pro iQ

Device

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

Primary outcomes

  1. Number of participants with a change in HbA1c of 5.5 mmol/mol or more

    Time frame: 12 weeks

    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

Secondary outcomes

  1. Change in the Diabetes Quality of Life (DQOL) score

    Time frame: 12 weeks

    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

Sponsors and collaborators

Lead sponsor

University of Hull

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 28, 2022
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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