PMID- 32519221
OWN - NLM
STAT- MEDLINE
DCOM- 20201207
LR  - 20210122
IS  - 1432-5233 (Electronic)
IS  - 0940-5429 (Linking)
VI  - 57
IP  - 11
DP  - 2020 Nov
TI  - 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.
PG  - 1307-1314
LID - 10.1007/s00592-020-01556-y [doi]
AB  - 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.
FAU - Marsters, Brooke L
AU  - Marsters BL
AD  - Department of Women's and Children's Health, University of Otago, Dunedin, New 
      Zealand.
FAU - Boucher, Sara E
AU  - Boucher SE
AD  - Department of Women's and Children's Health, University of Otago, Dunedin, New 
      Zealand.
FAU - Galland, Barbara C
AU  - Galland BC
AD  - Department of Women's and Children's Health, University of Otago, Dunedin, New 
      Zealand.
FAU - de Lange, Michel
AU  - de Lange M
AD  - Centre for Biostatistics, Division of Health Sciences, University of Otago, 
      Dunedin, New Zealand.
FAU - Wiltshire, Esko J
AU  - Wiltshire EJ
AD  - Department of Paediatrics and Child Health, University of Otago, Wellington, New 
      Zealand.
FAU - de Bock, Martin I
AU  - de Bock MI
AD  - Department of Paediatrics, University of Otago, Christchurch, New Zealand.
AD  - Paediatric Department, Canterbury District Health Board, Christchurch, New 
      Zealand.
FAU - Elbalshy, Mona M
AU  - Elbalshy MM
AD  - Department of Women's and Children's Health, University of Otago, Dunedin, New 
      Zealand.
FAU - Tomlinson, Paul A
AU  - Tomlinson PA
AD  - Paediatric Department, Southern District Health Board, Invercargill, New Zealand.
FAU - Rayns, Jenny
AU  - Rayns J
AD  - Endocrinology Department, Southern District Health Board, Dunedin, New Zealand.
FAU - MacKenzie, Karen E
AU  - MacKenzie KE
AD  - Paediatric Department, Canterbury District Health Board, Christchurch, New 
      Zealand.
FAU - Chan, Huan
AU  - Chan H
AD  - Department of Endocrinology and General Medicine, Canterbury District Health 
      Board, Christchurch, New Zealand.
FAU - Wheeler, Benjamin J
AU  - Wheeler BJ
AUID- ORCID: 0000-0003-3348-5238
AD  - Department of Women's and Children's Health, University of Otago, Dunedin, New 
      Zealand. ben.wheeler@otago.ac.nz.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20200609
PL  - Germany
TA  - Acta Diabetol
JT  - Acta diabetologica
JID - 9200299
RN  - 0 (Adhesives)
RN  - 0 (Blood Glucose)
SB  - IM
MH  - Adhesives/adverse effects/analysis
MH  - Adolescent
MH  - Adult
MH  - Blood Glucose/analysis
MH  - Blood Glucose Self-Monitoring
MH  - Cross-Over Studies
MH  - Diabetes Mellitus, Type 1/blood/*drug therapy
MH  - Female
MH  - Humans
MH  - Male
MH  - New Zealand
MH  - Young Adult
OTO - NOTNLM
OT  - Adhesive patch
OT  - Adolescent
OT  - Cutaneous adverse event
OT  - Flash glucose monitoring
OT  - Type 1 diabetes
OT  - Youth
EDAT- 2020/06/11 06:00
MHDA- 2020/12/15 06:00
CRDT- 2020/06/11 06:00
PHST- 2020/03/31 00:00 [received]
PHST- 2020/05/28 00:00 [accepted]
PHST- 2020/06/11 06:00 [pubmed]
PHST- 2020/12/15 06:00 [medline]
PHST- 2020/06/11 06:00 [entrez]
AID - 10.1007/s00592-020-01556-y [pii]
AID - 10.1007/s00592-020-01556-y [doi]
PST - ppublish
SO  - Acta Diabetol. 2020 Nov;57(11):1307-1314. doi: 10.1007/s00592-020-01556-y. Epub 
      2020 Jun 9.