Automated Insulin Delivery System Updates
By Adam Brown
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 |
|
- 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 |
|
- Bionic Pancreas iLet device: dual chambered pump with built-in algorithm; hybrid or fully closed loop; insulin-only or insulin+glucagon; custom infusion set - 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. |
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- 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. |
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|
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. |
