4
In February 2016, Insulet Corporation issued a press release announcing a license agreement with Mode AGC to commercialize an advanced Artificial Pancreas algorithm created by renowned researchers Francis Doyle PhD, Eyal Dassau PhD, and Howard Zisser MD at UC Santa Barbara. This algorithm is being further developed for a commercial product by Insulet. Insulet began their first human clinical trials in September 2016. To date, we’ve tested the system in 58 people with the youngest participant being six years of age. Early results showed excellent reduction in hypoglycemia. Our next set of clinical studies will further challenge the system with moderate intensity exercise and high-fat meals. This effort marks a significant step forward in Insulet’s mission to continue devel- oping innovative solutions for Omnipod ® Insulin Management System users. In maintaining the unique tubeless platform of the Omnipod ® System, the Omnipod Horizon TM Automated Glucose Control System will provide the same proven lifestyle benefits for users while offering better control through new hybrid closed-loop functionality. The algorithm will be embedded in the Pod itself to allow for continuous, on-body, automated glucose control. Insulet’s Pathway to Automated Glucose Control 800.591.3455 | 978.600.7850 | myomnipod.com (cont’d. on pg 3) Insulet’s Product Innovation Newsletter MARCH 2017 Horizon • The word ‘Horizon’ has meaning in the Artificial Pancreas space. The system can predict the horizon or trend of blood glucose, and adjust insulin requirements in real time. • At one time, Artificial Pancreas functionality was thought to be unattainable within the community — a lofty goal that would one day reduce the burden of care for people living with Type 1 Diabetes. Artificial Pancreas is now on the horizon and Insulet is developing a solution for patients. • The horizon may also be linked to the sunrise — it is a new day for Insulet with a laser focus on product innovation. What does our new brand stand for? (cont’d. on pg 4) Click here to view the latest Insulet press release, announcing the initial clinical trial activity for the Omnipod Horizon TM Automated Glucose Control System. *Up to 72 hours of continuous insulin delivery INNOVATIONS ON THE HORIZON • Users can remain discreet with a reliable tubeless form factor that gives them the freedom and comfort they deserve. • The user can expect up to 3 days* of nonstop insulin delivery, making it easier to stay connected and avoid the disruption of insulin delivery for normal activities like exercise and bathing. • With the new, hybrid closed loop func- tionality, the system intends to also deliver automated glucose control, making diabetes management an even smaller part of life for the users it serves as well as their caregivers. CAUTION– Investigational device. Limited by Federal (or United States) law to investigational use. Not for sale in the United States. [ Intended for Use with Healthcare Providers Only ]

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Page 1: InnovationsMarch2017Issue v10a linkstlchosted.com/Insulet_Q12017_Newsletter/... · require user input? Will the system be an implantable device? To shed light on the intended functionality

In February 2016, Insulet Corporation issued a press release announcing

a license agreement with Mode AGC to commercialize an advanced Artificial Pancreas algorithm created by renowned researchers Francis Doyle PhD, Eyal Dassau PhD, and Howard Zisser MD at UC Santa Barbara. This algorithm is being further developed for a commercial product by Insulet. Insulet began their first human clinical trials in September 2016. To date, we’ve tested the system in 58 people with the youngest participant being six years of age. Early results showed excellent reduction in hypoglycemia. Our next set of clinical studies will further challenge the system with moderate intensity exercise and high-fat meals. This effort marks a significant step forward in Insulet’s mission to continue devel-oping innovative solutions for Omnipod® Insulin Management System users.

In maintaining the unique tubeless platform of the Omnipod® System, the Omnipod HorizonTM Automated Glucose Control System will provide the same proven lifestyle benefits for users while offering better control through new hybrid closed-loop functionality. The algorithm will be embedded in the Pod itself to allow for continuous, on-body, automated glucose control.

Insulet’s Pathway to Automated Glucose Control

800.591.3455 | 978.600.7850 | myomnipod.com

(cont’d. on pg 3)

Insulet’s Product Innovation Newsletter MARCH 2017

Horizon™ • The word ‘Horizon’ has meaning in the

Artificial Pancreas space. The system can predict the horizon or trend of blood glucose, and adjust insulin requirements in real time.

• At one time, Artificial Pancreas functionality was thought to be unattainable within the community — a lofty goal that would one day reduce the burden of care for people living with Type 1 Diabetes. Artificial Pancreas is now on the horizon and Insulet is developing a solution for patients.

• The horizon may also be linked to the sunrise — it is a new day for Insulet with a laser focus on product innovation.

What does our new brand stand for?

(cont’d. on pg 4)

Click here to view the latest Insulet press release, announcing the initial clinical trial activity for the Omnipod HorizonTM Automated Glucose Control System.

*Up to 72 hours of continuous insulin delivery

INNOVATIONSO N T H E H O R I Z O N

• Users can remain discreet with a reliable tubeless form factor that gives them the freedom and comfort they deserve.

• The user can expect up to 3 days* of nonstop insulin delivery, making it easier to stay connected and avoid the disruption of insulin delivery for normal activities like exercise and bathing.

• With the new, hybrid closed loop func-tionality, the system intends to also deliver automated glucose control, making diabetes management an even smaller part of life for the users it serves as well as their caregivers.

CAUTION– Investigational device. Limited by Federal (or United States) law to investigational use. Not for sale in the United States.

[ Intended for Use with Healthcare Providers Only ]

Page 2: InnovationsMarch2017Issue v10a linkstlchosted.com/Insulet_Q12017_Newsletter/... · require user input? Will the system be an implantable device? To shed light on the intended functionality

LANDSCAPETHE ARTIFICIAL PANCREAS

2

The Two Approaches1 There are two major system-level approaches to achieving hybrid closed- loop control of blood glucose. The unihormonal approach uses insulin to reduce blood glucose and relies on complex safety mitigation algorithms to reduce the risk of hypoglycemia. The bihormonal approach uses both insulin to lower blood glucose and glucagon to raise blood glucose. This approach also relies on complex algorithms to provide safety for the user. All fi rst generation devices will use a unihormonal approach as the properties of glucagon are still being clinically tested.

In addition, all fi rst generation, commer-cially-available systems will include a proprietary algorithm strategy to help control blood glucose for users.

Although fi rst generation hybrid closed-loop systems will automate basal insulin delivery overnight, they will still require meal boluses (similar to current pump therapy throughout the day) and therefore should not be considered “hands-free” systems. In clinical studies to date, the most benefi cial time for these systems has been overnight, as a result of the

improved glucose control during that time. The aim of these systems is to deliver insulin safely to reduce the duration of prolonged hypoglycemia as well as hyperglycemia.

What is the MPC algorithm? The Omnipod HorizonTM Automated Glucose Control System is intended to include a personalized Model Predictive Control (MPC) algorithm. This smart technology predicts future glucose and insulin needs for the user to ensure that the appropriate insulin treatment plan is continuously delivered throughout the day. The use of this algorithm permits insulin-dosing instructions to be given for a future predicted blood glucose value, thereby helping to mitigate problems resulting from the temporal delays that are associated with the slow action of subcutaneously administered insulin.

The MPC algorithm is intended to be integrated inside the waterproof* Pod which is a true differentiator among other Artifi cial Pancreas technologies on the horizon. This feature is intended to allow for uninterrupted insulin delivery for up to 72 hours, a similar discreet footprint to the current Pod and a fully functioning on-body automated glucose control system.

Model Predictive Control (MPC) Algorithm

The MPC algorithm is intended to be embedded inside the Pod, simplifying Insulet’s Automated Glucose Control System.

Insulet is committed to product innovation and continuing to deliver products that offer unmatched quality of life benefi ts for the PodderTM community.

Frank C.

SINCE BEFORE HE COULD EVEN WALK

TM

Guilana P.Guilana P.

SINCE 2016

TM

Katie R.Katie R.Katie R.

SINCE 2015

TM

Kelly L.Kelly L.Kelly L.

SINCE 2014

TM

1. Ann. N.Y. Acad. Sci. 1311 (2014) 102-123. The Artifi cial Pancreas: Current Status and Future Prospects in the Management of Diabetes. Thomas Peyser, Eyal Dassau, Marc Breton, Jay S. Skyler.

*The Pod has an IPX8 rating for up to 25 feet for 60 minutes. The PDM is not waterproof.

*The Pod has an IPX8 rating for up to 25 feet for 60 minutes. The PDM is not waterproof.

CAUTION– Investigational device. Limited by Federal (or United States) law to investigational use. Not for sale in the United States.

[ Intended for Use with Healthcare Providers Only ]

Page 3: InnovationsMarch2017Issue v10a linkstlchosted.com/Insulet_Q12017_Newsletter/... · require user input? Will the system be an implantable device? To shed light on the intended functionality

Integrating the MPC algorithm on the Pod is intended to provide:

OMNIPOD HORIZONTM AUTOMATED GLUCOSE CONTROL SYSTEM

3

What does a hybrid closed-loop Artificial Pancreas system mean, and what will it accomplish for Omnipod® users?“Artificial Pancreas” is the term that most people are using to describe the next generation in diabetes care for people living with Type 1 Diabetes. However, do patients and potential users truly understand what the initial systems will accomplish for them? For example, will the system require user input? Will the system be an implantable device?

To shed light on the intended functionality of the initial Artificial Pancreas systems to hit the market, including Insulet’s, it may help to focus on the term “smart insulin pump” or hybrid closed-loop. Closed-loop refers to using sensor glucose values to make real-time insulin delivery decisions. The term ‘hybrid’ refers to the fact that it’s not a fully-automated system and still requires user input. These will include meal boluses or delivering insulin before meals are consumed. When compared to the current pumps on the market that only deliver preset insulin rates, hybrid closed-loop is intended to provide better glucose control for users by reacting to glucose predictions. Hybrid closed-loop shall enable customized and automatic adjusting of insulin delivery based on CGM data to help better maintain blood glucose levels. If the user’s glucose increases, the pump increases insulin automatically as needed. If the glucose is falling, it will reduce and potentially stop insulin delivery before the user reaches dangerously low glucose levels. Insulet’s system is intended to also include an enhanced user interface to delight the user and improve their overall experience. From a clinical perspective, the Omnipod HorizonTM System is intended to cater to each specific user by:• Limiting hyper- and hypoglycemic events.• Increasing their time in target blood glucose range (70 mg/dL - 180 mg/dL).

• Reducing their number of glycemic excursions.

Innovative technologies in one integrated system: • The Omnipod® System platform will be used to administer precise doses of insulin as

calculated by the proprietary Model Predictive Control (MPC) algorithm.• The robust personalized MPC algorithm which will be embedded within the Pod itself.• The latest Dexcom CGM will transmit estimated blood glucose to the Pod.• A handheld device controller with interactive and intuitive user interface enabling the user

to view current data and trends as well as to facilitate their meal announcements.

• A secure cloud server for robust data management capabilities including the collection, storage, and if desired, the sharing of important user data.

(cont’d. from pg 1)

FAQsQ: How will the Personal Diabetes

Manager (PDM) come into play with the new Omnipod HorizonTM Automated Glucose Control System?

A: The PDM will start a new Pod or sensor and deliver meal boluses, but will not be needed to run closed-loop. The system intends to work as a fully functioning on-body system by communicating between the Pod and the CGM device through BluetoothTM communication.

Q: Will Omnipod HorizonTM Automated Glucose Control System still be waterproof?

A: The system intends to maintain the same IPX 8 rating for the Pod.

Q: When is the Omnipod HorizonTM Automated Glucose Control System due to launch?

A: The timeline is still being refined and will depend on the clinical study roadmap. The goal continues to be launching a commercial product as rapidly as possible.

Click here to view our video to learn more about our Automated Glucose Control System

Our Mission The Omnipod HorizonTM

Automated Glucose Control

System, considered a hybrid

closed-loop system, intends

to revolutionize diabetes

treatment and enhance the

user experience by:

1. Reducing the day-to-day burden of the disease

2. Improving clinical outcomes

3. Improving quality of life overall

CAUTION– Investigational device. Limited by Federal (or United States) law to investigational use. Not for sale in the United States.

• 72 hours of uninterrupted control • Similar footprint to Omnipod® Insulin Management System

• Fully-functioning on-body Artificial Pancreas system

[ Intended for Use with Healthcare Providers Only ]

Page 4: InnovationsMarch2017Issue v10a linkstlchosted.com/Insulet_Q12017_Newsletter/... · require user input? Will the system be an implantable device? To shed light on the intended functionality

INNOVATIONEach circle shape represents our commitment to the pursuit of a hybrid-closed loop, automated glucose control system.

QUALITY OF LIFEThe circle has no beginning or end and signifies our tight knit Podder™ community.

CLINICAL BENEFITS72 marks around each circle means 72 hours of continuous insulin delivery.3 layers mean 3 days of continuousinsulin delivery with the Pod.Array of dots around the circle illustrates user data points or blood glucose BG readings.The design resembles a bullseye, symbolizingincreased time in target BG range for users.

An algorithm can predict the horizon of blood glucose and adjust insulin requirements.The horizon can be linked to "sunrise" - It is a new day for Insulet with laser focus on product innovation.

HORIZON ™

Horizon™ brandOmnipod® and Horizon™ brands

INNOVATIONEach circle shape represents our commitment to the pursuit of a hybrid-closed loop, automated glucose control system.

QUALITY OF LIFEThe circle has no beginning or end and signifies our tight knit Podder™ community.

CLINICAL BENEFITS72 marks around each circle means 72 hours of continuous insulin delivery.3 layers mean 3 days of continuousinsulin delivery with the Pod.Array of dots around the circle illustrates user data points or blood glucose BG readings.The design resembles a bullseye, symbolizingincreased time in target BG range for users.

An algorithm can predict the horizon of blood glucose and adjust insulin requirements.The horizon can be linked to "sunrise" - It is a new day for Insulet with laser focus on product innovation.

HORIZON ™

Horizon™ brandOmnipod® and Horizon™ brands

INNOVATION – Each circle shape represents our commitment to the pursuit of

a hybrid closed-loop, automated glucose control system.

CLINICAL BENEFITS – 72 marks around each circle means up to 72 hours of

continuous insulin delivery.– Three layers mean up to 3 days* of continuous insulin

delivery with the Pod.– Array of dots around the circle illustrates user data points

or blood glucose (BG) readings.– The design resembles a bullseye, symbolizing increased

time in target BG range for our users.

QUALITY OF LIFE – The circle has no beginning or end and signifies our

tight-knit PodderTM community.

HORIZONTM – The system can predict the horizon or trend of blood glucose

and adjust insulin requirements in real time. – The horizon can be linked to sunrise — it’s a new day for

Insulet with a laser focus on product innovation.

INNOVATIONEach circle shape represents our commitment to the pursuit of a hybrid-closed loop, automated glucose control system.

QUALITY OF LIFEThe circle has no beginning or end and signifies our tight knit Podder™ community.

CLINICAL BENEFITS72 marks around each circle means 72 hours of continuous insulin delivery.3 layers mean 3 days of continuousinsulin delivery with the Pod.Array of dots around the circle illustrates user data points or blood glucose BG readings.The design resembles a bullseye, symbolizingincreased time in target BG range for users.

An algorithm can predict the horizon of blood glucose and adjust insulin requirements.The horizon can be linked to "sunrise" - It is a new day for Insulet with laser focus on product innovation.

HORIZON ™

Horizon™ brandOmnipod® and Horizon™ brands

INNOVATIONEach circle shape represents our commitment to the pursuit of a hybrid-closed loop, automated glucose control system.

QUALITY OF LIFEThe circle has no beginning or end and signifies our tight knit Podder™ community.

CLINICAL BENEFITS72 marks around each circle means 72 hours of continuous insulin delivery.3 layers mean 3 days of continuousinsulin delivery with the Pod.Array of dots around the circle illustrates user data points or blood glucose BG readings.The design resembles a bullseye, symbolizingincreased time in target BG range for users.

An algorithm can predict the horizon of blood glucose and adjust insulin requirements.The horizon can be linked to "sunrise" - It is a new day for Insulet with laser focus on product innovation.

HORIZON ™

Horizon™ brandOmnipod® and Horizon™ brands

INNOVATIONEach circle shape represents our commitment to the pursuit of a hybrid-closed loop, automated glucose control system.

QUALITY OF LIFEThe circle has no beginning or end and signifies our tight knit Podder™ community.

CLINICAL BENEFITS72 marks around each circle means 72 hours of continuous insulin delivery.3 layers mean 3 days of continuousinsulin delivery with the Pod.Array of dots around the circle illustrates user data points or blood glucose BG readings.The design resembles a bullseye, symbolizingincreased time in target BG range for users.

An algorithm can predict the horizon of blood glucose and adjust insulin requirements.The horizon can be linked to "sunrise" - It is a new day for Insulet with laser focus on product innovation.

HORIZON ™

Horizon™ brandOmnipod® and Horizon™ brands

*Up to 72 hours of continuous insulin delivery

– Omnipod® and HorizonTM brands– HorizonTM brand

© 2017 Insulet Corporation. Omnipod, the Omnipod logo, Horizon, the Horizon logo and Podder are trademarks or registered trademarks of Insulet Corporation. All rights reserved. 17906-5A-AW R2 03/17

[ Intended for Use with Healthcare Providers Only ]