A Skin Care Program to Prevent Skin Problems due to Diabetes Devices in Children and Adolescents: A Cluster-Controlled Intervention Study

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

OBJECTIVE
Diabetes devices that deliver insulin and measure blood glucose levels are cornerstones in modern treatment of type 1 diabetes. However, their use is frequently associated with the development of skin problems, particularly eczema and wounds. Proper skin care may prevent skin problems, yet evidence-based information from interventional studies is missing. Providing this information is the aim of this study.

RESEARCH DESIGN AND METHODS
This cluster-controlled intervention study tested the efficacy of a basic skin care program (including use of lipid cream, removal, and avoidance of disinfection). A total of 170 children and adolescents with type 1 diabetes were included and assigned either to the intervention group (n = 112) or the control group (n = 58). Participants were seen quarterly the first year after device initiation, with clinical assessment and interview in an unblinded setting.

RESULTS
Eczema or wounds were observed in 33.6% of the intervention group compared with 46.6% of control participants (absolute difference, 12.9% [95% CI −28.7%, 2.9%]; P = 0.10). The adjusted odds of wound development were decreased by 71% in the intervention compared with control group (for wounds, odds ratio 0.29 [95% CI 0.12, 0.68]; P = 0.005). In total, only eight infections were seen, without a higher frequency in the intervention group, despite advice to omit disinfection.

CONCLUSIONS
These data indicate our basic skin care program partially prevented diabetes device–induced skin reactions. However, more preventive strategies with other adhesives, patches, and/or types of lotions are needed for optimized prevention.
OriginalsprogEngelsk
TidsskriftDiabetes Care
Vol/bind46
Udgave nummer10
Sider (fra-til)1770-1777
Antal sider8
ISSN0149-5992
DOI
StatusUdgivet - 2023

Bibliografisk note

Funding Information:
Medtronic and TEVA Pharma had no influ ence on data collection, analysis, or reports. Duality of Interest. A.K.B. has received consulting fees from Convatec and lecture fees from Rubin Medical. J.P.T. received support for this study from Sanofi Genzyme; is an advisor for AbbVie, Al-mirall, Arena Pharmaceuticals, Coloplast, OM-85, Aslan Pharmaceuticals, Union Therapeutics, LEO Pharma, Pfizer, Regeneron, and Sanofi-Genzyme; a speaker for AbbVie, Almirall, LEO Pharma, Pfizer, Regeneron, and Sanofi-Genzyme; and has received research grants from Pfizer, Regeneron, and Sanofi-Genzyme. J.S. has received lecture fees from Rubin Medical. No other potential conflicts of interest relevant to this article were reported. Author Contributions. A.K.B., S.U.T., J.P.T., C.Z., and J.S. formed the initial aim and concept of this study, A.K.B. wrote the first draft of the analysis plan, to which all authors made substantial revisions. A.K.B., A.C.G., and F.S. collected the study data. A.K.B. conducted data management steps and statistical analyses. S.U.T. and J.S. supervised the statistical analyses and interpretations. J.S. was the primary supervisor on the full study, including obtaining regulatory approvals, funding, and procedure approval for this study, and also directly assessed and verified the underlying data reported in manuscript. All authors had made substantial revisions to and critically reviewed the manuscript, and approved the final version. A.K.B. and J.S. are the guarantors of this work and, as such, had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Prior Presentation. Preliminary data, including 6 months of follow-up, were presented in an oral presentation at the International Conference on Advanced Technologies and Treatments for Diabetes, Barcelona, Spain, 27–30 April 2022. A non–peer-reviewed version of this article was posted on the SSRN preprint server on 13 February 2023 (https://papers.ssrn.com/sol3/papers.cfm ?abstract_id=4352548).

Funding Information:
This study was only possible with the support from all the children, adolescents, and their parents who participated in the project. We thank the nurses and doctors at both hospitals for their assistance in recruitment of participants for the study, and we thank the statisticians from Biostatistical Institute at University of Copenhagen for their contributions. Last, we thank our colleague Olivia McCarthy for language editing the manuscript, which she did without financial support. Funding. This study was financially supported by a research grant from the Danish Diabetes Academy, which, in turn, is funded by the Novo Nordisk Foundation (grant NNF17SA0031406), the Aase and Ejnar Danielsens Grant, a medical grant from University of Copenhagen, the Aage Bangs Dermatological Grant, the Holms Fund of memory, a scholarship from the Research Board of Herlev and Gentofte Hospital, and an external research program from Medtronic (to A.K.B., F.S., and J.S.). All Decubal 70% Lipid Cream was supplied by TEVA Pharma to A.K.B. and J.S. Medtronic and TEVA Pharma had no influence on data collection, analysis, or reports.

Funding Information:
Acknowledgments. This study was only possible with the support from all the children, adolescents, and their parents who participated in the project. We thank the nurses and doctors at both hospitals for their assistance in recruitment of participants for the study, and we thank the statisticians from Biostatistical Institute at University of Copenhagen for their contributions. Last, we thank our colleague Olivia McCarthy for language editing the manuscript, which she did without financial support. Funding. This study was financially supported by a research grant from the Danish Diabetes Academy, which, in turn, is funded by the Novo Nordisk Foundation (grant NNF17SA0031406), the Aase and Ejnar Danielsens Grant, a medical grant from University of Copenhagen, the Aage Bangs Dermatological Grant, the Holms Fund of memory, a scholarship from the Research Board of Herlev and Gentofte Hospital, and an external research program from Medtronic (to A.K.B., F.S., and J.S.). All Decubal 70% Lipid Cream was supplied by TEVA Pharma to A.K.B. and J.S.

Publisher Copyright:
© 2023 by the American Diabetes Association. All rights reserved.

ID: 375794926