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Reduced Pain, Increased Compliance, Faster Kinetics with Intradermal Injection in Type 1 Kids

Intradermal insulin injection via a microneedle provided less pain and increased kinetics….

Patients received injections via a hollow microneedle of lispro insulin. The patients rated the pain experienced during insertion and infusion. Blood samples were collected to determine glucose and insulin concentrations.

In this randomized, open-label, five-way crossover study, 29 T1DM children and adolescents received IL and RHI (0.125 U/kg) at 2 min and 17 min premeal, respectively, by both the SC and ID routes and also received RHI by the ID route at 2 min premeal. Blood glucose was stabilized at 120 mg/dL prior to a standardized 82-g carbohydrate liquid meal. ID delivery used a 34-gauge 1.5-mm steel microneedle, and SC delivery used a 31-gauge 8-mm syringe needle. The pain was significantly lower with the microneedle compared to subcutaneous injections. The onset and offset of the insulin injected via the microneedle was faster than normal subcutaneous injections.

The 90-min PPG (blood glucose area under the curve for 0-1.5 h) for ID RHI was 14% lower than SC RHI at -17 min (P < 0.0001) and 11% lower than ID RHI at -2 min (P = 0.0006). PPG did not differ between ID RHI and SC IL, both at -2 min (P = 0.8345). ID IL PPG was lower than SC, both at -2 min, but not significantly (P = 0.10). Both ID IL and ID RHI PK data showed significantly faster uptake and time to maximum concentration, higher maximum concentration, and shorter systemic circulating duration versus SC dosing. ID IL and RHI delivery was generally well tolerated.

The reduction in pain from the use of the microneedle could lead to an increase in compliance. Increased compliance leads to better maintained type 1 diabetes with fewer future complications. The faster onset of insulin and decrease in average time to peak insulin level could also lead to tighter glucose control.

This study indicates that ID insulin delivery is superior to SC delivery in speed of systemic availability and PK consistency and may improve postprandial glucose control. James J Norman, Milton R Brown, Nicholas A Raviele, Mark R Prausnitz, Eric I Felner. Faster pharmacokinetics and increased patient acceptance of intradermal insulin delivery using a single hollow microneedle in children and adolescents with type 1 diabetes. Pediatric Diabetes. 21 Mar 2013