INSULET CORPORATION’S DEDICATION TO INNOVATION
Insulet has changed the lives of individuals with insulin-requiring diabetes across the globe with the Omnipod® Insulin Management System. In addition to our new Omnipod DASH™ Insulin Management System, we are also actively developing innovative new products to reduce the burden of diabetes management and improve quality of life for people with diabetes.
Insulet Product Roadmap
Insulet is working to bring innovation to life
Fiasp® FDA Approved for the Omnipod® Insulin Management System
What is Fiasp®?
Fiasp® is a rapid-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. Fiasp® is considered a “quicker” version of the mealtime insulin, NovoLog®, that is used to control high blood sugar in adults with insulin-requiring diabetes. It is designed to start working fast by entering the bloodstream in approximately 2.5 minutes. See below for the Pharmacokinetic profile of Fiasp® vs. NovoLog®:
How does Fiasp® compare to other commonly used insulins on the market?
Fiasp® is a formulation of insulin aspart, the same active ingredient in Novolog that is proven to help control blood sugar upon eating. Two ingredients were added to create Fiasp® including a form of vitamin B3 (niacinamide), which increases the speed of initial insulin absorption, and an amino acid to aid stability. Fiasp® is the first mealtime insulin without a pre-meal dosing recommendation giving users a few options for when they can take it (either 5-10 minutes prior to a meal, at the start of the meal or 20 minutes after starting a meal).
Fiasp® is available in a FlexTouch® pre-filled insulin pen as well as in a 10 mL vial. For more details on the features and benefits of Fiasp® for patients and prescribers, please visit:
Will the faster onset and more rapid clearance of Fiasp® interfere with IOB calculations?
No. The onset of action is faster with Fiasp®, by about 26 minutes on average but the duration of action is approximately the same, therefore the duration of insulin action on the pump can be kept the same or adjusted per advice from the healthcare provider. The Pod has not been modified.
Is Fiasp® more expensive that other insulins?
Pricing for Fiasp® is in the same price range as Novolog, but marginally more expensive than other rapid acting insulins on the market today. Fiasp® has dedicated savings/copay cards available to streamline access for users: https://www.novocare.com/fiasp/savings-card.html
Why is the Fiasp® indication important for existing adult Omnipod® users?
Insulet has completed extensive testing with the support of Novo Nordisk to demonstrate that Fiasp® can be used with the Omnipod® Insulin Management System as well as the Omnipod DASH™ System. The Omnipod® Insulin Management System is the first tubeless insulin pump in the United States to obtain this indication and deliver additional flexibility for patients to use their insulin of choice with the Pod. Expanding the Omnipod® System’s labeling to include Fiasp® also opens the door for existing Fiasp® users to seamlessly transition to an Omnipod® platform for their insulin delivery needs.
Please note, in the United States, Fiasp® is approved for use as CSII in the adult population only and is not indicated for use with pediatrics at this time, and therefore Fiasp® should only be used with Omnipod® System for adult patients only. Novo Nordisk is currently working on a supplement to remove this restriction and as such, we will inform the community once Fiasp® is approved for use with pediatrics.
Additional insulins that are indicated for use within the Pod include: Novolog®, Humalog®, Admelog®, and Apidra®. We believe everyone should have affordable access to the therapy of their choice. For more information, please visit advocacyforaccess.com.
Where can users find instructions for use and prescribing information for Fiasp®?
Visit the following link for specific indications for use by the manufacturer:
How will this indication be reflected in our Omnipod® User Guide(s) and labeling?
Per our labeling, the patient is advised to consult their HealthCare Provider prior to changing their insulin type. The Omnipod® System and Omnipod DASH™ System will not automatically adjust insulin settings.
When are the User Guides estimated to be available for distribution?
The updated User Guides are in process and will be included within our printed inventory for new patient starts as soon as possible. In the meantime, we will be updating MyOmnipod.com with a digital copy as soon as its available.
Omnipod DASH™ Insulin Management System
The Omnipod DASHTM System is a wearable insulin pump that delivers up to 200 units of U-100 insulin through customizable basal rates and bolus amounts. The system consists of the Personal Diabetes Manager (PDM) and the Pod, which is worn on body and delivers non-stop insulin for three days.* The Omnipod DASHTM System has been tested and found to be safe for use with the following U-100 insulin: Novolog®, Humalog®, Apidra®, or Admelog®.
Omnipod HORIZON™ Automated Glucose Control System
Insulet is working on the Omnipod HORIZONTM System to commercialize a hybrid closed loop system. The intended design of the system is to utilize estimated glucose values from a Continuous Glucose Monitor (CGM) to predict future blood glucose and adjust insulin delivery. The HORIZONTM System will leverage the technology of the DASHTM Insulin Management System on a smart phone.
*The Omnipod HORIZON™ System is an investigational device, limited by United States Law to Investigational Use
Insulet collaboration with Tidepool Loop Program
Insulet announced it will be working with Tidepool, a non-profit organization that is working on an open-source, iOS based app and algorithm. The algorithm runs on a mobile app on an iPhone. Insulet and Tidepool are developing an automated insulin delivery system utilizing the Tidepool Loop algorithm, an Omnipod® Pod, and a Continuous Glucose Monitor. Tidepool Loop is intended to be delivered by Tidepool as a supported, FDA-regulated mobile app in the App Store.
*Not FDA approved. Not available for sale in the US
Insulet is working on bringing a version of the Omnipod® System to market that will be indicated for use with concentrated insulins. This product aims to fill the need for higher insulin requiring patients, both Type 1 and Type 2.
*Not 510(k) cleared. Not available for sale in the US
With Horizon, Insulet will be the first to deliver tubeless, personal smartphone controlled, automated insulin delivery. Horizon’s unique form factor and the incredible design work that has gone into securing our algorithm on the pod, give Insulet strong competitive advantages over other AID devices.
Horizon’s architecture is uniquely positioned to provide more time in closed-loop, because we have taken the time to put the algorithm directly on our disposable pod, rather than on an accompanying device the user must carry around. Our engineering teams have worked closely with their colleagues at Dexcom to enable the Dexcom sensor to speak directly to our pod, without requiring a PDM or phone to be in closed-loop. These highly complex technical programs require great collaboration and great design and engineering work to keep the user experience simple.
We are extremely excited to be in the final stages of our development work and to bring our advanced system to the diabetes community next year.
President and Chief Executive Officer
Important Safety Information: The Omnipod® Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood from the finger. The glucose measurements should not be used for the diagnosis or screening for diabetes. The Personal Diabetes Manager (PDM) glucose meter is intended for single-patient use and should not be shared. The Omnipod® System has been tested and found to be safe for use with the following U-100 insulin: Novolog®/NovoRapid®, Humalog®, Apidra®, Admelog®. Refer to the Omnipod® Insulin Management System User Guide at myomnipod.com for complete safety information including indications, contraindications, warnings, cautions, and instructions.