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[Insuject-X for children. A clinical trial of the NPH insulin pen]
Insights
Insuject-X, a novel insulin pen, proved safe and effective for children with insulin-dependent diabetes mellitus, maintaining metabolic control and showing high acceptance despite some technical challenges.
Area of Science:
- Pediatric Endocrinology
- Diabetes Technology
- Pharmacology
Background:
- Insulin-dependent diabetes mellitus (IDDM) requires consistent glycemic management in children.
- Traditional syringe injections can be challenging for pediatric patients.
- Novel insulin delivery devices aim to improve convenience and adherence.
Purpose of the Study:
- To evaluate the safety and efficacy of the Insuject-X insulin pen for delivering NPH insulin in children with IDDM.
- To assess metabolic control and patient acceptance of the Insuject-X device compared to conventional syringes.
Main Methods:
- A study involving 21 children (age ≤ 10 years) with recent-onset IDDM (≤ 1 year).
- Initial one-month period using conventional syringe injections, followed by a four-month period using the Insuject-X pen.
- Monitoring metabolic control, insulin potency in cartridges, technical issues, and patient/parental acceptance.
Main Results:
- No significant changes in metabolic control were observed between syringe and Insuject-X use.
- Mean NPH insulin potency in partly used cartridges was 103.6 ± 5.6 IU/ml, with no correlation to residual volume or usage duration.
- Higher incidence of technical problems noted in children compared to adults, suggesting a need for reinforced usage instructions.
- No microbial contamination or local injection site reactions were reported.
- High acceptance and preference for the Insuject-X pen were reported by all children.
Conclusions:
- The Insuject-X insulin pen is a safe and effective delivery device for NPH insulin in pediatric patients with IDDM.
- While generally well-accepted and convenient, specific training may be needed to mitigate technical issues in younger users.
- The device maintained metabolic control, offering a viable alternative to traditional syringe injections for children.
Abstract:
The use of Insuject-X for NPH insulin was tested by 21 children, age less than or equal to 10 years with insulin dependent diabetes mellitus less than or equal to 1 year, on conventional treatment with NPH insulin once or twice daily. After a preliminary period of one month the syringe injection regimen was changed to injections by Insuject-X for a four-month "pen" period. We observed no significant changes in metabolic control. The mean potency of NPH insulin in partly used cartridges was 103.6 +/- 5.6 IU/ml (range 91.0-118.1, n = 39) with no correlation to the residual volume or days of use. Measurements over 110 IU/ml were seen at the end of the study indicating the need of repeated instruction in use of the pen by children. No microbial contamination of the cartridges, nor any local reactions at injection sites were found. We observed more technical problems than in adult studies indicating that children handle the pen more roughly. The accept of Insuject-X was good as a more convenient means of injecting. All of the children preferred to continue using it.