Flash-glucose Monitoring in Sub-optimally Controlled Type 1 Diabetes (FLASH-UK)

Summary

FreeStyle Libre (FSL2) is a novel glucose monitoring device (Flash glucose monitoring) in the form of a disc worn on the arm for 14 days, and a hand-held reader which is designed to largely replace the recommended 4-10 painful finger-stick blood glucose tests required each day for the self-management of type 1 diabetes. The purpose of this study is to determine whether flash glucose monitoring with FSL2 device will improve HbA1c over 24 weeks compared to self-monitoring of blood glucose in adults and adolescents (16 or older) with sub-optimally controlled (HbA1c 7.5% to 11%) type 1 diabetes.

This is an open-label, multi-centre, randomised, parallel design study, involving a 2-week run-in period, followed by a 24-week study period during which participants will use either FSL2 or continue usual finger-stick glucose monitoring in random order. A total of up to 156

randomised participants from up to 180 recruited aged 16 years and older with T1D on insulin pump therapy or multiple daily injection therapy were recruited through diabetes clinics in participating centres.

Participants will receive appropriate training to maximise the benefits of FSL2 and finger-stick glucose levels in self-management. The primary outcome is the difference in HbA1c between the two groups at 24 weeks. Secondary outcomes are time spent with glucose levels above and below target, as recorded by FSL2, and other flash glucose-based metrics. Impact on quality of life, diabetes distress, mood, needle burden, disordered eating and treatment satisfaction will also be undertaken. Relative cost-effectiveness of FSL2 device compared with self-monitoring will also be assessed from a UK NHS perspective.

Conditions

• Diabetes Mellitus, Type 1

Interventions

DEVICE

Free Style Libre 2

FreeStyle Libre 2 (FSL2) is a novel glucose monitoring device (Flash glucose monitoring) in the form of a disc worn on the arm for 14 days and a hand-held reader which is designed to largely replace the recommended 4-10 painful finger-stick blood glucose tests required each day for the self-management of type 1 diabetes (T1D).

Sponsors & Collaborators

• University Hospitals of Derby and Burton NHS Foundation Trust

  collaborator OTHER

• Cambridge University Hospitals NHS Foundation Trust

  collaborator OTHER

• Portsmouth Hospitals NHS Trust

  collaborator OTHER_GOV

• University Hospital Birmingham NHS Foundation Trust

  collaborator OTHER

• Norfolk and Norwich University Hospitals NHS Foundation Trust

  collaborator OTHER

• University of Manchester

  collaborator OTHER

• Diabetes UK

  collaborator OTHER

• Clinical Trials Unit, Manchester

  collaborator OTHER

• BHR Limited

  collaborator INDUSTRY

• East Suffolk and North Essex NHS Foundation Trust

  collaborator OTHER

• The Adam Practice

  collaborator OTHER

• Manchester University NHS Foundation Trust

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-09

Primary Completion

2021-10-10

Completion

2021-10-10

Countries

• United Kingdom

Study Locations