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Clinical testing results and high patient satisfaction with a new needle-free device for growth hormone in young
J H Silverstein1, F T Murray, T Malasanos
1Department of Pediatric Endocrinology, University of Florida, Gainesville, USA.
Insights
A new needle-free device for growth hormone delivery was evaluated in children with type 1 diabetes mellitus. The device proved easier to use and was preferred over traditional needles, with minimal reported pain and discomfort.
Area of Science:
- Pediatric Endocrinology
- Medical Device Technology
- Diabetes Management
Background:
- Type 1 diabetes mellitus requires regular injections, often causing anxiety and pain in children.
- Growth hormone delivery traditionally relies on needle-based methods, posing challenges for pediatric adherence.
- Needle-free technologies offer a potential alternative for improved patient comfort and compliance.
Purpose of the Study:
- To evaluate a novel needle-free device for growth hormone delivery in children.
- To compare the needle-free device against traditional insulin needle injections regarding user experience and preference.
- To assess pediatric patient perceptions of pain, worry, and local reactions associated with the new device.
Main Methods:
- Fifty children (ages 4-10) with type 1 diabetes mellitus participated.
- Children completed questionnaires on device-related nervousness, pain, erythema, stinging, and wetness.
- Comparative questions assessed ease of use, pain, nervousness, and overall preference versus insulin needles.
Main Results:
- Minimal pain (92%), erythema (96%), worry (90%), stinging (86%), and wetness (96%) were reported with the needle-free device.
- Comfort rings did not significantly alter responses.
- The needle-free device was rated easier to use (p < 0.03) and significantly preferred (p < 0.001) by 74% of children under 10.
Conclusions:
- The needle-free growth hormone delivery device is well-tolerated by children with type 1 diabetes mellitus.
- It offers a less painful and preferred alternative to traditional needle injections for pediatric patients.
- This technology may enhance treatment adherence and improve the quality of life for children requiring growth hormone therapy.
Abstract:
Fifty children ages 4-10 yr with type 1 diabetes mellitus volunteered to participate in a study to evaluate and compare a new needle-free device developed for growth hormone delivery. Children answered descriptive questions related to nervousness and worry, hurt or pain, redness or bleeding, and stinging and wetness. Choices for answers for each of these five questions were none, a little, or a lot. None or a little was also combined to give a minimal category. Children also answered four questions that compared the needle-free device to their morning insulin needle injection in reference to ease of use, pain, nervousness, and overall preference. Half the children had single comfort rings inserted to increase the injection pressure. Results indicated no difference in question responses with or without pressure rings. Pain (92%), erythema (96%), worry (90%), stinging (86%) and wetness (96%) were minimal and significant (0.001 > p < 0.03) following all questions. Results of the comparative questionnaire indicated that the device was easier (p < 0.03) to use than needles and significantly preferred (p < 0.001) in 74% of children under age 10.
