Medtronic announced yesterday that it has launched two trials – an in-home study of its 780G advanced hybrid closed loop (AHCL) system and a multi-clinic trial of an upgraded continuous glucose monitor (CGM) sensor for its Guardian Connect CGM.
This announcement was reported by Close Concerns in the publication’s roundup of news from the second day of The American Diabetes Association 79th Scientific Sessions.
Both trials can be seen as significant steps in Medtronic’s goal of bringing a true closed-loop automated insulin pump system to market. Currently, Medtronic 670G is the only automated insulin pump system on the market which automatically adjusts basal insulin delivery based on CGM readings.
About the 780G trial
-Medtronic has already begun enrolling participants for a feasibility study of at-home use of the new pump system, which would automate bolus deliveries based on “user experiences, or is predicted to experience, prolonged high glucose levels based on their sensor reading.”
-The 780G is intended to also automate basal insulin delivery, mimicking the abilities of the 670G.
-The trial will enroll up to 350 adult and pediatric patients with type 1 diabetes to use the device over a three-month period
-The trial will primarily measure both HbA1c and Time in Range (time spent between 70 mg/dL and 180 mg/dL) of participants using the 780g system. It also will evaluate the number of bouts of hypoglycemia and diabetic ketoacidosis participants may experience.
-The trial is estimated to be completed in January 2020, with results presented in July 2020.
-For more information on how to enroll, click here. You can also contact the research coordinators to ask for more info – Thomas Troub (firstname.lastname@example.org) and Melissa Vella (email@example.com).
About the Guardian Connect sensor trial
-This is a 7-day clinical study of the third-generation of the Guardian Connect CGM sensor, which is designed to only require fingerstick calibration during the first day of wear.
-It will enroll up to 460 participants, and is open to people with type 1 diabetes and people with type 2 diabetes.
-Researchers will measure the accuracy of the sensor against traditional lab blood draws.
-The study is estimated to be completed by February 2020.
-To learn more information about this trial click here. No contact info has yet been listed for this trial.
T1D Exchange is not connected with these trials and cannot enroll participants.
Editor’s note: The above photo is of the Medtronic 670G. While the most recent Medtronic pump systems have stayed close to a similar design with one another, official photos have not yet been released of the proposed 780G.