Faster pharmacokinetics and increased patient acceptance of intradermal insulin delivery using a single hollow microneedle in children and adolescents with type 1 diabetes

• Published in: Pediatric diabetes Vol. 14; no. 6; pp. 459 - 465
• Main Authors: Norman, James J, Brown, Milton R, Raviele, Nicholas A, Prausnitz, Mark R, Felner, Eric I
• Format: Journal Article
• Language: English
• Published: Former Munksgaard John Wiley & Sons A/S 01.09.2013
• Subjects: Adolescent; Adolescent Behavior; Attitude to Health; Catheters, Indwelling; Child; Child Behavior; Diabetes Mellitus, Type 1 - blood; Diabetes Mellitus, Type 1 - drug therapy; Diabetes Mellitus, Type 1 - metabolism; Drug Delivery Systems - adverse effects; drug-delivery systems; Female; Georgia; Humans; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - blood; Hypoglycemic Agents - pharmacokinetics; Hypoglycemic Agents - therapeutic use; Infusions, Subcutaneous; Injections, Intradermal; insulin; Insulin Infusion Systems - adverse effects; Insulin Lispro - administration & dosage; Insulin Lispro - blood; Insulin Lispro - pharmacokinetics; Insulin Lispro - therapeutic use; Male; Materials Testing; microneedles; Needles; pain; Pain Measurement; pharmacodynamics; pharmacokinetics; Georgia; microneedles; pharmacokinetics; pain; insulin; drug-delivery systems; pharmacodynamics
• ISSN: 1399-543X; 1399-5448; 1399-5448
• DOI: 10.1111/pedi.12031

Objective In an effort to improve compliance with insulin therapy and to accelerate insulin pharmacokinetics, we tested the hypothesis that intradermal insulin delivery using a hollow microneedle causes less pain and leads to faster onset and offset of insulin pharmacokinetics in children and adolescents with type 1 diabetes (T1DM) compared with a subcutaneous, insulin pump catheter. Research design and methods In this repeated measures study, 16 children and adolescents with T1DM received Lispro insulin by microneedle and subcutaneous administration on separate days. Subjects rated the pain of insertion and infusion using a visual analog scale. Blood specimens were collected over 4 h to determine insulin and glucose concentrations. Results Microneedle insertion pain was significantly lower compared with insertion of the subcutaneous catheter (p = 0.005). Insulin onset time was 22 min faster (p = 0.0004) and offset time was 34 min faster (p = 0.017) after hollow microneedle delivery compared with subcutaneous delivery. Conclusions In this study, intradermal insulin delivery using a single, hollow microneedle device resulted in less insertion pain and faster insulin onset and offset in children and adolescents with T1DM. A reduction in pain might improve compliance with insulin delivery. The faster onset and offset times of insulin action may enable closed‐loop insulin therapy.