Children with diabetes mellitus often fail to monitor their blood glucose concentration because of the fear, pain, and inconvenience associated with lancet-piercing of their skin to obtain capillary blood for glucose measurement. Diabetics who do not routinely monitor glucose levels are more likely to have poor glycemic control, ultimately leading to an increased risk for chronic complications. Our multidisciplinary team has addressed this problem by developing microneedles that can be integrated into a transdermal patch and applied to the skin to collect interstitial fluid. Current glucose sensors utilize interstitial fluid for sensing glucose concentration. These sensors have a strong correlation with capillary and venous glucose. Because of their small size, microneedles can be easy and painless to insert.

The goal of this proposal is to develop microneedle patches for glucose monitoring using interstitial fluid in order to reduce pain in children with diabetes.

We plan to manufacture microneedle patches for interstitial fluid collection and evaluate the efficacy and acceptability of glucose monitoring by three simultaneous methods:

1) interstitial fluid collection from the microneedle patch;

2) capillary glucose from a finger prick with a conventional lancet; and

3) venous plasma glucose from an intravenous catheter. Glucose levels and pain will be assessed and compared at each time point for each subject. We believe the collection of interstitial fluid and measurement of the glucose concentration from microneedle patches will be as or more accurate as glucose measured from capillary blood but, will be less painful and more acceptable for children with diabetes. This study is novel in that it introduces a new technology that could facilitate improved glycemic control in diabetic children and that it conducts a first-in-humans study to assess this technology in a pediatric population.