Evidence map›Paper›PMID 32519221›Full record

Trial reportActa diabetologica2020

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, Sara E Boucher, Barbara C Galland, Michel de Lange, Esko J Wiltshire, Martin I de Bock, Mona M Elbalshy, Paul A Tomlinson, Jenny Rayns, Karen E MacKenzie and 2 more

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Acta diabetologica, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 36% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 3 institutions in 1 country.

Brooke L MarstersDepartment of Women's and Children's Health, University of Otago, Dunedin, New Zealand.
Sara E BoucherDepartment of Women's and Children's Health, University of Otago, Dunedin, New Zealand.
Barbara C GallandDepartment of Women's and Children's Health, University of Otago, Dunedin, New Zealand.
Michel de LangeCentre for Biostatistics, Division of Health Sciences, University of Otago, Dunedin, New Zealand.
Esko J WiltshireDepartment of Paediatrics and Child Health, University of Otago, Wellington, New Zealand.
Martin I de BockDepartment of Paediatrics, University of Otago, Christchurch, New Zealand.
Mona M ElbalshyDepartment of Women's and Children's Health, University of Otago, Dunedin, New Zealand.
Paul A TomlinsonPaediatric Department, Southern District Health Board, Invercargill, New Zealand.
Jenny RaynsEndocrinology Department, Southern District Health Board, Dunedin, New Zealand.
Karen E MacKenziePaediatric Department, Canterbury District Health Board, Christchurch, New Zealand.
Huan ChanDepartment of Endocrinology and General Medicine, Canterbury District Health Board, Christchurch, New Zealand.
Benjamin J WheelerDepartment of Women's and Children's Health, University of Otago, Dunedin, New Zealand. ben.wheeler@otago.ac.nz.ORCID http://orcid.org/0000-0003-3348-5238
University of Otago · NZCanterbury District Health Board · NZSouthern District Health Board · NZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsAlthough 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).

methodsThis 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.

resultsThirty-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).

conclusionsThe 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.

Indexed as

AdhesivesAdolescentAdultBlood GlucoseBlood Glucose Self-MonitoringCross-Over StudiesDiabetes Mellitus, Type 1FemaleHumansMaleNew ZealandYoung AdultAdhesivesBlood GlucoseAdhesive patchAdolescentCutaneous adverse eventFlash glucose monitoringType 1 diabetesYouth

Identifiers

PMID32519221
OpenAlexW3033571573

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.