FreeStyle Libre Monitoring in T2DM

Last updated: December 19, 2024
Sponsor: University of Hull
Overall Status: Completed

Phase

N/A

Condition

Diabetes Mellitus, Type 2

Treatment

Glucose monitoring using FreeStyle Libre 2

Glucose monitoring using FreeStyle Libre pro iQ

Clinical Study ID

NCT05597293
301630
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Participants with a life expectancy of less than 1 year

  • Participants with cognitive dysfunction or neurological disorder, which willinterfere with regular, flash glucose monitoring

  • Participants with chronic kidney disease (CKD) with eGFR < 45ml/min/1.73m2 ordecompensated liver disease or decompensated congestive cardiac failure

  • Myocardial infarction in the preceding 3 months or if percutaneous coronaryintervention planned in the next 6 months

  • Participants on supra-physiological doses of steroids, for example, Prednisolone forthe 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 glucosemeasurements or management

  • Women who are pregnant, breastfeeding or planning to become pregnant. Women shoulduse 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 orneurostimulators

  • Participants with an allergy to medical grade adhesive

  • A blood transfusion in the preceding 3 months or a planned blood transfusion duringthe course of the study

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Glucose monitoring using FreeStyle Libre 2
Phase:
Study Start date:
February 27, 2023
Estimated Completion Date:
May 02, 2024

Study 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.

Connect with a study center

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

    Hull, HU32RW
    United Kingdom

    Site Not Available

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