Dive Brief:

• A $6 million funding commitment will help a diabetes technology nonprofit develop an app for hybrid closed-loop automated insulin delivery. Called the Tidepool Loop, the technology is meant to work with multiple insulin pumps and continuous glucose monitoring devices. The software will be designed for the iOS App Store as an FDA-regulated mobile application.
• Financing for the technology came from the Leona M. and Harry B. Helmsley Charitable Trust and JDRF. The new funding will support Tidepool in expanding its software development and customer support operations. 
• An observational study of current Loop users, funded by the Helmsley trust, will be conducted by the Jaeb Center for Health Research in Tampa, Florida. Recruitment for the study is expected to begin in early 2019.

Dive Insight:

Automated insulin delivery systems monitor blood glucose levels and use an algorithm to determine the correct amount of insulin to provide when needed.

Several medical device makers are working to develop and market closed loop insulin delivery systems, which are sometimes referred to as an artificial pancreas. The purpose is to improve blood sugar control for people with Type 1 diabetes, maintaining a healthy glucose range and preventing highs and lows. Such devices also aim to eliminate the need for patients to prick their fingers to check their blood sugar and to manually inject insulin.

Medtronic's MiniMed 670G hybrid closed loop artificial pancreas, approved in September 2016, was a breakthrough, combining a continuous glucose monitoring (CGM) system that communicates with an insulin pump. Patients using the system still must enter carbohydrate information at mealtime and calibrate the sensor with periodic finger sticks.

Dexcom makes a continuous glucose monitor (CGM) that uses a sensor inserted just below the skin to provide blood sugar readings every five minutes to a smartphone or Dexcom receiver. Competitors in the CGM market include Abbott Laboratories, maker of the Freestyle Libre device, and Senseonics Holdings, which in August received approval for an implantable CGM.

The grant to California-based Tidepool will provide the nonprofit software organization with the initial funding it needs to begin developing Tidepool Loop with the goal of compatibility with multiple insulin pumps and continuous glucose monitoring devices. The organization said it is partnering with Insulet to support the company's Omnipod Dash insulin management system with the Tidepool Loop. Commercial release of that product is anticipated in early 2019.

Tidepool, a pilot participant in the FDA Digital Health Software Precertification Pilot Program, also said it is working with FDA to use the Loop project as a test case for the program. All code, designs and intellectual property that Tidepool produces will be released in the open.

"This is exactly what we dreamed of when we launched the JDRF Open Protocol Initiative in 2017 – to accelerate innovation, give users greater control over insulin delivery devices, and expand their ability to choose system components that work best for them," Aaron Kowalski, chief mission officer for JDRF, said in a press release. "Through the Tidepool Loop project, Tidepool will demonstrate the power and value of an interoperable ecosystem of diabetes devices, giving people with diabetes more options for better control with less burden."