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

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.

Ultrasound Detected Subcutaneous Changes in a Pediatric Cohort After Initiation of a New Insulin Pump or Glucose Sensor.

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.