Innovations in Progress

 

Changing the face of insulin pump therapy


The information below discusses development programs not approved by the FDA. This information is intended for investors researching the company, and is updated in conjunction with public announcements about our product pipeline. All dates below are as of March 1, 2018. Tandem undertakes no obligation to update or review any forward-looking information below based on new information, future events or other factors.
From the beginning, we have taken a unique approach to product development. All of our products have been developed through an extensive, user-centric process involving thousands of interviews with pump users and healthcare providers. In addition, we have employed Human Factors research heavily in our development process. The first product from these efforts was the t:slim® Insulin Pump, the first-generation touchscreen pump which consistently ranked #1 by pump users in independent research.1

Since then, we have also developed the Tandem Device Updater to deliver remote software updates for our insulin pumps through a customer’s personal computer, and a second-generation pump, the t:slim X2 Insulin Pump that builds on the original with a variety of improvements including an advanced Bluetooth radio for communication with future technologies.2

Below is a list of products we are working on for people with diabetes that continue our commitment to user-centric design and development.
 

 

 

Automated Insulin Delivery

Predictive Low Glucose Suspend (PLGS)

Our first-generation Automated Insulin Delivery (AID) system is planned to include a Predictive Low Glucose Suspend (PLGS) algorithm. The algorithm will use CGM data to help predict future hypoglycemia (low blood sugar) before it happens and is designed to adjust insulin to help minimize the frequency and or duration of hypoglycemic events. The algorithm was developed internally in consultation with thought leaders in Automated Insulin Delivery and Artificial Pancreas research.

Timelines as of 3/1/2018:
  -  Feasibility study completed in Q3 2016
  -  Pivotal study completed and PMA filed with FDA in Q1 2018
  -  Launch goal:  Summer 2018

 

 

Predictive_Low_Glucose_Suspend_Algorithm

Graph is for illustrative purposes only, and does not reflect individual results.

 

 

Hybrid_Closed_Loop_Algorithm

Graph is for illustrative purposes only, and does not reflect individual results.

Automated Insulin Delivery

Hybrid Closed Loop (HCL)

In July 2016 we announced a license agreement with TypeZero Technologies to accelerate development of a hybrid closed loop system. TypeZero’s AP technology includes a series of treat-to-range algorithms developed by TypeZero from initial research conducted at the University of Virginia. In 2016, this technology had been used in more than 30 clinical studies including more than 450 participants, with data referenced in a number of journal articles.3

Tandem, Dexcom and TypeZero are working together on the integration of their technologies into the NIH-funded International Diabetes Closed Loop (IDCL) Trial. Tandem is working on development of an insulin pump that integrates the data from a Dexcom G6 sensor and TypeZero’s inControl algorithm directly into the pump’s touchscreen interface.

Timelines as of 3/1/2018:
  -  Pivotal data to be generated by ongoing IDCL Trial
  -  Launch goal:  1H 2019

 

1. dQ&A USA Diabetes Connections Surveys, 2013-2016. 
2. Software updates and new features are not currently available for the t:slim X2 Pump and are subject to future FDA approvals. Charges may apply.
3. Recent Publications Highlighting Research Using TypeZero AP Technology:  (a) Ly T, Buckingham B, DeSalvo et al. Day-and-Night Closed-Loop Control Using the Unified Safety System in Adolescents With Type 1 Diabetes at Camp. Diabetes Care 2016 Aug; 39(8): e106-e107.  (b) Anderson S, Raghinaru D, Pinsker J, et al.  Multinational Home Use of Closed-Loop Control Is Safe and Effective. Diabetes Care. 2016 Jul;39(7):1143-50.  (c) Boris P. Kovatchev, Eric Renard, Claudio Cobelli, et al. Safety of Outpatient Closed-Loop Control: First Randomized Crossover Trials of a Wearable Artificial Pancreas. Diabetes Care. 2014 Jul; 37(7): 1789–1796.

© 2018 Tandem Diabetes Care, Inc. All rights reserved.