Ultrasound Detected Subcutaneous Changes in a Pediatric Cohort after Initiation of a New Insulin Pump or Glucose Sensor
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Objective: This study examined subcutaneous tissue changes at sites used by continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM), and tested whether these changes, if any, were associated with glycated hemoglobin (HbA1c). Research Design and Methods: This prospective study investigated recently used CSII or CGM sites in 161 children and adolescents during the first year after initiation of a new diabetes device. Subcutaneous changes such as echogenicity, vascularization, and the distance from the skin surface to the muscle at CSII and CGM sites were assessed by ultrasound. Results: The distance from skin surface to muscle fascia at both the upper arm and abdomen was influenced by age, body mass index z-score, and sex. Especially in boys and the youngest, the depth of many devices outreached the mean distance. The mean distance for boys at the abdomen and upper arm ranged from 4.5-6.5 mm and 5-6.9 mm for all ages, respectively. Hyperechogenicity at CGM sites was 4.3% after 12 months. The frequency of subcutaneous hyperechogenicity and vascularization at CSII sites increased significantly over time (41.2% to 69.3% and 2% to 16% respectively, P < 0.001 and P = 0.009). Hyperechogenicity in the subcutis was not a predictor of elevated HbA1c (P = 0.11). Conclusion: There is large variation in the distance from the skin surface to the muscle fascia and many diabetes devices reach even deeper. Hyperechogenicity and vascularization increased significantly over time at CSII sites, but not CGM sites. The importance of hyperechogenicity for insulin absorption is unclear and further investigations are needed. Clinical Trial Registration number: NCT04258904.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Diabetes Technology and Therapeutics |
| Vol/bind | 25 |
| Udgave nummer | 9 |
| Sider (fra-til) | 622-630 |
| Antal sider | 9 |
| ISSN | 1520-9156 |
| DOI | |
| Status | Udgivet - 2023 |
Bibliografisk note
Funding Information:
We thank all the participants and their caregivers who participated in the project and made this research possible. A special acknowledgment to Annemarie Cecilie Grauslund as study personnel, who contributed to the study by both inclusion of participants and data collection. Also, an acknowledgment to Claus Zachariae, Jacob Pontoppidan Thyssen, and Steffen Ullitz Thorsen who all supervised in the initiation of the overall prospective skin study. We also thank the nurses and doctors at the pediatric diabetes teams at both Herlev and Hillerød hospitals for their assistance in recruiting patients for the study. The authors acknowledge the statistical support from Section of Biostatistics at Copenhagen University. Moreover, thanks to researcher, Olivia McCarthy for providing English language editing on the article.
Funding Information:
This study was financially supported by a research grant from the Danish Diabetes Academy, which is funded by the Novo Nordisk Foundation, grant number NNF17SA0031406, Ingrid Munkholms Grant, a scholarship from the Research Board of Herlev and Gentofte Hospital and an external research program from Medtronic, but Medtronic had no influence on data collection, analysis, or reports.
Funding Information:
F.M.W.S.: Part of her salary was paid by the external research program from Medtronic described under funding. J.S. serves as an adviser to Medtronic and Novo Nordisk. She owns shares in Novo Nordisk and has received fees for speaking on behalf of Medtronic, Rubin Medical, and Novo Nordisk. A.K.B. has received speaking fees from Rubin Medical and Convatec and part of her salary was paid by the external research program from Medtronic described under funding.
Publisher Copyright:
Copyright © 2023, Mary Ann Liebert, Inc., publishers 2023.
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