By Dr. Douglas Denham
Type 1 Diabetics are constantly in search of newer, better treatments since their disease requires 24/7 monitoring. One of the new products released for Type 1 Diabetes is the new GVOKE ready-to-use glucagon. This treatment for severe hypoglycemia makes it much easier for family or friends to help people with severe hypoglycemia. Unlike the previous glucagon pen, there is no mixing. It is a room-temperature, liquid, stable glucagon that is ready to use in an emergency. It was released in October of this year and is available in pharmacies now. An EpiPen-like auto-injector, GVOKE HypoPen, will be launched at some point in 2020.
In the treatment of Type 1 Diabetes, the Holy Grail has been an “artificial pancreas.” This would consist of a pump with algorithms that would be able to adjust the amount of insulin delivered by the pump based on continuous glucose monitoring data being fed to it by glucose sensors on or in the skin. While progress has been made, the FDA has been reluctant to approve any of these programs due to concerns about the pump stopping insulin for too long (when blood sugars get too low) and causing problems with hyperglycemia (low glucose suspension). Fortunately, the FDA has now given Medtronic the green light to conduct ASPIRE, the first major outpatient trial of a low glucose suspend product in the US. With positive results, progress to an artificial pancreas can occur. Check out Clinicaltrials.gov to find a study site near you.
In the area of continuous glucose sensors, there are many new products on the market. Medtronic is testing its new Elite sensor, already approved in Europe. This sensor lasts 6 days and is expected to be more reliable than previous sensors.
The Eversense has two implantable glucose sensors. The 90-day version is approved in the U.S. and the 180-day sensor is in testing in order to get US approval for it. Both are available in Europe. What makes this one so different is that after placement, there’s no worry about it falling off, or having to change it every 7, 10 or 14 days. The transmitter, which is worn over the sensor, needs to be charged once a day. It sends blood glucose readings to an iPad device or phone. The current version has a high and low blood sugar warning that causes the transmitter to vibrate, signaling that the blood sugar is low or high. Once the sensor expires, it can be replaced by having it removed and a new one placed in the same incision made to remove it.
In the area of insulins, new studies are being conducted with new biosimilar insulins. Biosimilars are insulins that are an almost identical copy of the original product manufactured by a different company. Since they are so similar in action and effect, they can be used in place of the original product. And since they are so similar, the companies making them do not have to go through the same rigorous and expensive testing that the original product did to get approved. Since the cost of developing the biosimilar is so much smaller, the biosimilar should not be as expensive to the consumer.
Clinical Trials of Texas, Inc. (CTT) conducts investigational device and medication studies for both Type 1 and Type 2 Diabetes. Schedule yourself online today for a prescreen https://saresearch.com/diabetes-screening-2/
Douglas Scott Denham, DO, CPI is Chief Medical Director of Clinical Trials of Texas, Inc. (CTT) and is board-certified in family medicine, with more than 25 years of experience treating metabolic diseases such as diabetes, obesity and liver disease.