H.5 Rapid Insulin Efficacy Test

Insulin is made in the body’s pancreas as the protein that regulates an individual’s blood sugar.  Type I diabetic patients (and many type II diabetic patients) require injectable insulin in order to help regulate their blood sugar, as they don’t produce insulin (Type I) or have relative insulin insensitivity (Type II).  

Unopened injectable insulin must be refrigerated and kept at a temperature between 360F and 460F. If the insulin gets too warm, it denatures and is less effective or completely ineffective.  So if a patient’s insulin sits in the warm car too long while running errands, or in a suitcase on a long trip or a flight delay, or because there is a supply chain issue that delayed a shipment for 2 days while the package sat on a loading dock, the insulin may be completely ineffective and a patient will never know it. The ineffective insulin can cause dangerously high blood sugars.  Often times after a patient’s blood sugar keeps climbing, patients dose far too much insulin attempting to get the less-potent insulin to work.  Worse, a controversial 2017 study (linked below) bought 18 separate vials of different insulins from different pharmacies and found that not one vial met the FDA required minimum concentration (95 U/mL), with the average concentration measuring less than half the required potency (avg: 40.2 U/mL). 

https://journals.sagepub.com/doi/full/10.1177/1932296817747292?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub++0pubmed&

Currently, there are no commercially available rapid tests to evaluate the efficacy and potency of insulin.  The only way for patients to know if their insulin is good is to visually inspect the insulin to see if it appears “cloudy” (highly unreliable) or to closely monitor blood sugar to see if it doesn’t get too high.   But even then they won’t know whether their insulin pump or glucose monitor has malfunctioned or whether the insulin is bad.  As the parent of a diabetic child, this is a struggle we know all too well. The goal of this project is to develop a quick, hopefully inexpensive test to evaluate the efficacy and possibly the potency of insulin.