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A randomized controlled pilot study of continuous glucose monitoring and flash glucose monitoring in people with Type 1 diabetes and impaired awareness of hypoglycaemia

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Title: A randomized controlled pilot study of continuous glucose monitoring and flash glucose monitoring in people with Type 1 diabetes and impaired awareness of hypoglycaemia
Authors: Reddy, M
Jugnee, N
El Laboudi, A
Spanudakis, E
Anantharaja, S
Oliver, N
Item Type: Journal Article
Abstract: AIM: Hypoglycaemia in Type 1 diabetes is associated with mortality and morbidity, especially where awareness of hypoglycaemia is impaired. Clinical pathways for access to continuous glucose monitoring (CGM) and flash glucose monitoring technologies are unclear. We assessed the impact of CGM and flash glucose monitoring in a high-risk group of people with Type 1 diabetes. METHODS: A randomized, non-masked parallel group study was undertaken. Adults with Type 1 diabetes using a multiple-dose insulin-injection regimen with a Gold score of ≥ 4 or recent severe hypoglycaemia were recruited. Following 2 weeks of blinded CGM, they were randomly assigned to CGM (Dexcom G5) or flash glucose monitoring (Abbott Freestyle Libre) for 8 weeks. The primary outcome was the difference in time spent in hypoglycaemia (below 3.3 mmol/l) from baseline to endpoint with CGM versus flash glucose monitoring. RESULTS: Some 40 participants were randomized to CGM (n = 20) or flash glucose monitoring (n = 20). The participants (24 men, 16 women) had a median (IQR) age of 49.6 (37.5-63.5) years, duration of diabetes of 30.0 (21.0-36.5) years and HbA1c of 56 (48-63) mmol/mol [7.3 (6.5-7.8)%]. The baseline median percentage time < 3.3 mmol/l was 4.5% in the CGM group and 6.7% in the flash glucose monitoring. At the end-point the percentage time < 3.3 mmol/l was 2.4%, and 6.8% respectively (median between group difference -4.3%, P = 0.006). Time spent in hypoglycaemia at all thresholds, and hypoglycaemia fear, were different between groups, favouring CGM. CONCLUSION: CGM more effectively reduces time spent in hypoglycaemia in people with Type 1 diabetes and impaired awareness of hypoglycaemia compared with flash glucose monitoring. (Clinical Trial Registry No: NCT03028220).
Issue Date: 1-Apr-2018
Date of Acceptance: 5-Dec-2017
URI: http://hdl.handle.net/10044/1/56092
DOI: https://dx.doi.org/10.1111/dme.13561
ISSN: 0742-3071
Publisher: Wiley
Start Page: 483
End Page: 490
Journal / Book Title: Diabetic Medicine
Volume: 35
Issue: 4
Copyright Statement: © 2017 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
Sponsor/Funder: National Institute for Health Research
DexCom Inc.
Imperial College Healthcare NHS Trust- BRC Funding
Funder's Grant Number: RDA11 79560
Iperial IIS-2015-014
RDA29
Keywords: Science & Technology
Life Sciences & Biomedicine
Endocrinology & Metabolism
CONTROLLED-TRIAL
MORTALITY
MULTICENTER
INJECTIONS
ADULTS
1103 Clinical Sciences
Publication Status: Published
Online Publication Date: 2017-12-12
Appears in Collections:Department of Medicine (up to 2019)