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Randomized Controlled Trial
. 2020 Nov;57(11):1307-1314.
doi: 10.1007/s00592-020-01556-y. Epub 2020 Jun 9.

The 'flash' adhesive study: a randomized crossover trial using an additional adhesive patch to prolong freestyle libre sensor life among youth with type 1 diabetes mellitus

Brooke L Marsters  1 , Sara E Boucher  1 , Barbara C Galland  1 , Michel de Lange  2 , Esko J Wiltshire  3 , Martin I de Bock  4   5 , Mona M Elbalshy  1 , Paul A Tomlinson  6 , Jenny Rayns  7 , Karen E MacKenzie  5 , Huan Chan  8 , Benjamin J Wheeler  9
Affiliations
Randomized Controlled Trial

The 'flash' adhesive study: a randomized crossover trial using an additional adhesive patch to prolong freestyle libre sensor life among youth with type 1 diabetes mellitus

Brooke L Marsters et al. Acta Diabetol. 2020 Nov.

Abstract

Aims: Although strategies to prevent premature sensor loss for flash glucose monitoring (FGM) systems may have substantial benefit, limited data are available. This study among youth with high-risk type 1 diabetes evaluated whether an additional adhesive patch over FGM sensors would reduce premature sensor loss frequency and not cause additional cutaneous adverse events (AEs).

Methods: This is a six-month, open-label, randomized crossover trial. Participants were recruited at completion of prior 'Managing Diabetes in a Flash' randomized controlled trial and allocated to three months of Freestyle Libre FGM sensors with either standard adhesive (control) or additional adhesive patches (RockaDex, New Zealand) (intervention), before crossing over to the opposite study arm. Participants self-reported patch use or non-use, premature sensor loss and cutaneous AEs fortnightly via an electronic questionnaire.

Results: Thirty-four participants were enrolled: mean age (± SD) 17.0 (± 2.2) years; mean HbA1c (± SD) 89 (± 16) mmol/mol (10.3% ± 1.4%). The response rate of questionnaires was 77% (314/408). Premature sensor loss was reported in 18% (58/314) of questionnaires: 20% (32/162) from intervention and 17% (26/152) from control (p = 0.56). Thirty-eight percent (118/314) of questionnaires were non-compliant to protocol allocation. However, per-protocol analysis showed similar findings. No significant difference in AEs was reported between compliant adhesive patch use and non-use (6% [5/78] and 3% [3/118], respectively, p = 0.27).

Conclusions: The adhesive patch investigated in this study does not appear to prevent premature FGM sensor loss. However, the low risk of AEs and low cost of an adhesive patch suggest an individualized approach to their use may still be warranted. Further research is needed to explore alternative strategies to prevent sensor loss.

Keywords: Adhesive patch; Adolescent; Cutaneous adverse event; Flash glucose monitoring; Type 1 diabetes; Youth.

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References

    1. Foster NC, Beck RW, Miller KM et al (2019) State of type 1 diabetes management and outcomes from the T1D exchange in 2016–2018. Diabetes Technol Ther 21(2):66–72. https://doi.org/10.1089/dia.2018.0384 - DOI - PubMed - PMC
    1. Prahalad P, Tanenbaum M, Hood K, Maahs DM (2018) Diabetes technology: improving care, improving patient-reported outcomes and preventing complications in young people with type 1 diabetes. Diabet Med 35(4):419–429. https://doi.org/10.1111/dme.13588 - DOI - PubMed
    1. Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger J, Weitgasser R (2016) Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet 388(10057):2254–2263. https://doi.org/10.1016/s0140-6736(16)31535-5 - DOI - PubMed
    1. Campbell FM, Murphy NP, Stewart C, Biester T, Kordonouri O (2018) Outcomes of using flash glucose monitoring technology by children and young people with type 1 diabetes in a single arm study. Pediatr Diabetes 19(7):1294–1301. https://doi.org/10.1111/pedi.12735 - DOI - PubMed
    1. Chase HP, Beck RW, Xing D et al (2010) Continuous glucose monitoring in youth with type 1 diabetes: 12-month follow-up of the Juvenile Diabetes Research Foundation continuous glucose monitoring randomized trial. Diabetes Technol Ther 12(7):507–515. https://doi.org/10.1089/dia.2010.0021 - DOI - PubMed

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