Tandem Diabetes Care Inc (NASDAQ:TNDM) has announced that it has enrolled its first patient in its trial for its t:slim X2™ Insulin Pump using the company’s predictive low glucose suspend (PLGS) technology. Tandem Diabetes Care is engaged in the manufacture of medical devices as well as touchscreen insulin pumps which are supplied in the United States. The company’s insulin pump system which makes use of the integrated Dexcom G5® Mobile Continuous Glucose Monitor (CGM), has been designed in a way that enables it to cut off delivery of insulin when levels of glucose start to rise.
The PROLOG study has been done on several randomized centers and compares two sessions of three weeks each. In one sessions, t:slim X2 Pump is used together with PLGS while in the second session, a standard CGM-integrated t:slim X2 Pump is used alone without any automated suspension of the insulin. A total of 90 patients with type 1 diabetes and aged 6 and above are expected to be enrolled in the study that will be done at five stations spread across the United States. The study will be coordinated by Jaeb Center on behalf of Health Research in Tampa, Florida. The study’s primary endpoint is to show a drop in CGM values below the 70 mg/dL mark in patients on Tandem’s PLGS algorithm.
In a statement, Tandem Diabetes Care president and CEO Kim Blickenstaff said the start of the study is a significant milestone in the company’s program that entails building a fully automated insulin delivery system. He added that they are fully committed to submitting the t:slim X2 Pump with very low glucose suspend to the Food and Drug Administration agency early 2018. Additionally, the company intends to make the feature available to its t:slim X2 customers through a remote software update through its Tandem Device Updater
Mild to moderate hypoglycemia is a common occurrence during the day among people with type 1 diabetes. Of more concern however is the severe hypoglycemia which mainly occurs at night and lead to seizures and in the severe cases even death. It is a major cause of worry for people suffering from type 1 diabetes as well as parents with children living with type 1 diabetes.
