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Automated Insulin Delivery System Updates

By Adam Brown, Ava Runge, and Nicole Kofman

Who is “closing the loop,” and how fast are they moving?

Below we include a list of organizations working to bring automated insulin delivery products to market – this includes their plans for pivotal studies and plans for an FDA submission. The organizations are ordered from shortest to longest time to a pivotal study, though these are subject to change. It’s not clear how long the FDA process will take for these devices, but we assume ~12 months is a good estimate. Some organizations have not disclosed pivotal study plans and are included further down the list. 

Company / Academic Group

Product

Latest Timing

Medtronic

- MiniMed 670G pump with built in hybrid closed loop algorithm (requires meal boluses)

- Enlite 3 CGM

FDA submission before end of June 2016; US launch hoped by April 2017

Tandem

 

- Tandem t:slim pump with built in predictive low glucose suspend algorithm; Dexcom CGM

- Tandem t:slim pump with built in Hypoglycemia-Hyperglycemia Minimizer algorithm; Dexcom CGM

- Pivotal trial in 2016, potential launch in 2017

 

- Pivotal study in 2017, potential launch by end of 2018

International Diabetes Closed Loop  (IDCL) Consortium (TypeZero, UVA, and nine other academic institutions)

Cellnovo + other undisclosed pump companies

- Commercial version of DiAs hybrid closed loop algorithm that can run on a pump or on a smartphone app.

- Dexcom CGM.

- Trial will use multiple pumps; Cellnovo has signed on thus far.

International Diabetes Closed-Loop Trial to begin later in 2016.

FDA submission potentially in 2017.

System recently tested in two ski studies in Wintergreen and Breckenridge

Beta Bionics

- Bionic Pancreas iLet device: dual chambered pump with built-in algorithm; hybrid or fully closed loop; insulin-only or insulin+glucagon; custom infusion set
- Dexcom CGM

- Likely to launch as insulin-only product, with glucagon to be optionally added later

Pivotal trial to start in mid-2017

FDA submission potentially in late 2017 or early 2018.

Bigfoot Biomedical

- Former Asante pump body (disposable), reusable Bluetooth-enabled controller (no screen or buttons) with built-in algorithm

- Dexcom CGM

- Smartphone app to serve as complete user interface.

Pivotal study in first half of 2017, FDA submission by the end of 2017.

Launch by the end of 2018.

Animas

- Animas pump with built-in Hypoglycemia-Hyperglycemia Minimizer algorithm

- Dexcom CGM

Currently planning pivotal study; no timing shared

Insulet

- OmniPod with hybrid closed loop algorithm and built-in Bluetooth

- Smartphone app and/or backup PDM handheld to communicate with pod

- Dexcom CGM

Pivotal study in late 2017

Cellnovo

No design details disclosed, but algorithm likely to reside in wireless handheld that controls body-worn patch pump.

 

- IDCL Consortium Partner (see above)

- Diabeloop consortium partner

- IDCL study starting in 2016

- Diabeloop trials were expected to start at the end of 2015, with European approval programs to run until 2018

Roche

Working internally on a new CGM, with future potential application to an artificial pancreas device

“On our agenda”

CGM expected to launch in Europe in 2016

Cambridge

Upcoming long-term studies will use Medtronic’s MiniMed 640G/Enlite 3 + Android phone running Cambridge’s MPC.

Commercialization plans unknown. Three upcoming studies ranging from three to 24 months in length.

 

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