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Ultrasound Detected Subcutaneous Changes in a Pediatric Cohort After Initiation of a New Insulin Pump or Glucose
Fiona M W Sørensen1,2, Jannet Svensson1,2, Christina Kinnander3
1Diabetes Technology, Clinical Research, Copenhagen University Hospital-Steno Diabetes Center Copenhagen, Herlev, Denmark.
Insights
Subcutaneous tissue changes occurred at insulin infusion and glucose monitoring sites in children and adolescents. These changes, particularly at insulin sites, increased over time but did not correlate with HbA1c levels.
Area of Science:
- Pediatric Endocrinology
- Medical Ultrasound
- Diabetes Technology
Background:
- Continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) are vital for managing type 1 diabetes in pediatric populations.
- Understanding the impact of these devices on subcutaneous tissue is crucial for optimizing device performance and patient outcomes.
- Previous research has not fully elucidated the longitudinal changes in subcutaneous tissue at CSII and CGM sites and their association with glycemic control.
Purpose of the Study:
- To investigate subcutaneous tissue alterations at CSII and CGM device sites in children and adolescents.
- To determine if these tissue changes correlate with glycated hemoglobin (HbA1c) levels.
- To assess the depth of device insertion relative to subcutaneous tissue and muscle fascia.
Main Methods:
- A prospective study involving 161 children and adolescents using CSII or CGM devices.
- Ultrasound imaging was employed to evaluate subcutaneous tissue characteristics, including echogenicity, vascularization, and skin-to-muscle distance.
- Data were collected during the first year of device use, with analyses considering age, BMI z-score, and sex.
Main Results:
- Subcutaneous tissue depth varied significantly, with many devices inserted deeper than the mean distance, particularly in boys and younger children.
- Hyperechogenicity was observed in 4.3% of CGM sites after 12 months.
- Subcutaneous hyperechogenicity and vascularization at CSII sites increased significantly over time (41.2% to 69.3% and 2% to 16%, respectively), but not at CGM sites.
- Hyperechogenicity was not found to be a predictor of elevated HbA1c.
Conclusions:
- There is substantial variability in subcutaneous tissue depth, with diabetes devices often inserted deeply.
- CSII sites showed a significant increase in hyperechogenicity and vascularization over time, unlike CGM sites.
- The clinical significance of subcutaneous hyperechogenicity for insulin absorption remains uncertain, necessitating further research.
Abstract:
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.
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