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Basal-IQ Algorithm

Who was involved in the development of the Basal-IQ algorithm?
The foundation of the Basal-IQ algorithm is based on years of work by diabetes researchers at leading academic institutions. Tandem’s engineers made enhancements to the algorithm and developed our simple user interface to support clinical trials and subsequent regulatory submissions that were needed before making it available for commercial use.

Why did you develop a PLGS system when you’re working on a hybrid closed loop system?
We began the commercial development for our PLGS system many years ago, and before there was a clear development path for products that include automated insulin delivery algorithms. Because of the lack of clarity at the time, Tandem elected to pursue an incremental strategy that we believed improved our chances of success. In addition, since hypoglycemia is a major health concern for people with type 1 diabetes, we were confident that our PLGS system would provide significant benefit while our hybrid closed loop system was still in clinical trials. The development of PLGS also provided us with substantial learnings in areas relating to product design, human factors and clinical trials that have been able to use to accelerate the development of our next-generation of products.

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Training and Support

How complex is the training for the Basal-IQ technology update?
The required training for the Basal-IQ technology update is simple and takes just 30-45 minutes and is available online through the t:connect® online portal. Patients will receive a unique Update ID Code once training is complete, which will allow them to update their pump software using a personal computer. Healthcare providers will work in conjunction with a Tandem representative to coordinate training for patients who receive prescriptions for a new t:slim X2™ insulin pumps preloaded with Basal-IQ technology.

Does the Basal-IQ feature require a prescription for my patients who already have a t:slim X2 insulin pump?
Yes. Because Basal-IQ technology automates an aspect of insulin therapy and uses a new continuous glucose monitoring (CGM) system, this update will require a prescription and online training. Any t:slim X2 pump users updating to the Basal-IQ feature are required to complete training before receiving their unique Update ID Code needed to update the pump software. The Basal-IQ technology update is only available to in-warranty t:slim X2 pump users.

Where does my patient get supplies for the system?
We work with each new customer to determine the best approach to get in-network coverage, whether that be directly through Tandem or one of our authorized distributors. Patients then order their supplies from Tandem or through their distributor. For existing Tandem pump users, there should be no change in the ordering process. The Dexcom G6 CGM is sold separately. Patients starting on CGM for the first time should contact Dexcom directly to place an order. Existing Dexcom customers will continue to order CGM supplies as they do currently.

Where can I go to learn how to use the pump menus and screens?
The t:simulator™ app is a free, interactive virtual demo of the t:slim X2 pump, available for download here. In addition to a pump simulation, you can also learn about technical specifications, the t:connect diabetes management application, and access a glossary of common terms. You can also view our Quick Reference sheets here.

Where can I go to figure out how to change pump settings?
In addition to downloading the t:simulator app, you can visit our patient Resources page, review Quick Reference Sheets, and review additional training videos and documents. For further support, contact our Customer Support Team at (877) 801-6901 or speak with your local rep.

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CGM Connectivity

How stable is the CGM connection for the t:slim X2 insulin pump with Basal-IQ technology?
CGM connectivity observed during the PROLOG trial was very good. When the Basal-IQ algorithm was on, the sensor was transmitting to the pump an average of 91% of the time during the three-week trial.1

Are patients kicked out of the Basal-IQ feature if they lose CGM signal?
Basal-IQ technology requires three of the last four CGM sensor values to make a prediction and suspend insulin based on the predicted value. However, it will suspend insulin delivery if there is only one CGM sensor reading is less than 70 mg/dL and it is the current CGM reading. If connectivity with the CGM is lost during a suspension and not resolved within 20 minutes, insulin delivery will automatically resume at the programmed basal rate. Basal-IQ technology will resume automatically once the pump and CGM are back in range, but three of the last four CGM readings are required before it can begin predicting glucose levels and automatically suspending insulin delivery based on these predictions.

What would cause a patient to have to do a fingerstick confirmation or calibration?
Failure to enter the Dexcom four-digit sensor code (found on the bottom of the Dexcom G6 sensor) into the insulin pump when starting a sensor session will prompt a calibration every 24 hours. Additionally, a blood glucose meter should be used to make diabetes treatment decisions if glucose alerts and CGM readings do not match symptoms or expectations or if taking over the recommended maximum dosage amount of 1,000 mg of acetaminophen every six hours.

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Clinical Trials

What studies are published on use of the Basal-IQ algorithm?
The PROLOG pivotal trial data has been published in the October 2018 issue of Diabetes Care. Reference: Forlenza GP, Li Z, Buckingham BA, Pinsker JE, et al. Predictive low-glucose suspend reduces hypoglycemia in adults, adolescents, and children with type 1 diabetes in an at-home randomized crossover study: Results of the PROLOG trial. Diabetes Care. 2018;41(10):2155-2161. doi:10.2337/dc18-0771.

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Data Management

I have recommendations for improvements to t:connect HCP. Whom can I contact?
Please contact your local Tandem team or call our Customer Technical Support team at (877) 801-6901.

How are you keeping patient data secure?
The t:slim X2 insulin pump uses Bluetooth® technology to communicate securely with compatible devices. Communication over Bluetooth is always encrypted and requires the user to manually pair the two devices using a link key that is never shared over the air. Tandem devices meet or exceed every requirement of the Diabetes Technology Society cybersecurity standards (DESec) for connected devices.

The t:connect HCP software is installed on a clinician’s computer and communicates directly with supported patient devices for upload to HIPAA-compliant web and database Tandem Diabetes Care servers. These servers are only accessible through a secure internet connection.

We secure patient data by placing it behind state-of-the-art firewalls and always encrypting it during data transfers and at the server level. Patients must provide permission for healthcare providers to access their information via the t:connect HCP application.

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Reimbursement

When will Medicare patients be able to view data on their pumps?
Medicare recently announced that they will allow Tandem pump users to view CGM data from covered CGM systems directly on their insulin pumps instead of on a separate, dedicated CGM receiver.

Patients with Dexcom G5 Mobile CGM systems can view data on their t:slim X2 pumps without jeopardizing Medicare coverage of their CGM supplies, provided that they occasionally use the CGM receiver that came with their Dexcom G5 Mobile CGM systems to view data (for example, during initial startup or while taking a break from pump therapy).

It was recently announced that Medicare plans to cover Dexcom G6 CGM supplies. Dexcom expects to begin shipping to Medicare patients beginning in April 2019. As with Dexcom G5 Mobile CGM integration, continued Medicare coverage for Dexcom G6 CGM supplies when integrating with t:slim X2 pumps will require that patients occasionally use their Dexcom receivers to view data.

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Tandem Diabetes Care

What is the history of Tandem as a company?
Tandem, in the early days, was a small group of engineers who wanted to find a new method of pumping insulin. There had been very little innovation with insulin pumps at the time since the early 1990s. Tandem Diabetes Care was created based on the efforts of these original engineers in early 2006.

The Company proceeded to interview thousands of insulin pump users and healthcare providers to figure out what the community felt was lacking in insulin pumps, and the result was the original t:slim® insulin pump, which was granted 510(k) clearance from the FDA on World Diabetes Day in November 2011. Since that time, the Company has used the same user-centric development approach to release a number of new technologies, including the Tandem Device Updater, which made Tandem the first company to allow its customers 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.*

Most recently, the release of the t:slim X2 insulin pump with Basal-IQ technology has reaffirmed the Company’s dedication to helping patients manage their diabetes.

Do you have a clinical advisory board?
We do not have a formal clinical advisory board. Instead, we engage individual thought leaders on a variety of projects based on their particular areas of expertise.

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* Additional feature updates are not currently available for the t:slim X2 pump with Basal-IQ technology and are subject to future FDA approvals. A prescription and additional training may be required to access certain future software updates. Charges may apply.

1. Forlenza GP, Li Z, Buckingham BA, Pinsker JE, et al. Predictive low-glucose suspend reduces hypoglycemia in adults, adolescents, and children with type 1 diabetes in an at-home randomized crossover study: Results of the PROLOG trial. Diabetes Care. 2018;41(10):2155-2161. doi:10.2337/dc18-0771.