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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
Author(s) -
Reddy M.,
Jugnee N.,
El Laboudi A.,
Spanudakis E.,
Anantharaja S.,
Oliver N.
Publication year - 2018
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/dme.13561
Subject(s) - medicine , continuous glucose monitoring , diabetes mellitus , randomized controlled trial , type 2 diabetes , clinical endpoint , hypoglycemia , type 1 diabetes , regimen , endocrinology
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 HbA 1c 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: NCT 03028220)