Memorandum

Control-IQ receives regulatory approval from Health Canada – November 23, 2020

New pumps with Control-IQ to begin shipping in 1Q21; for those already using Tandem, free software upgrade beginning in March 2021 for all in-warranty users; Basal-IQ still an option

Today, Tandem announced that it received regulatory approval from Health Canada for its t:slim X2 pump with the Control-IQ algorithm. This comes a year almost to the day after Tandem received Health Canada approval for Basal-IQ technology in November 2019, and today’s press release notes that Basal-IQ will continue to be offered for Canadian users for those interested in a system that focuses even more deliberately on preventing hypoglycemia.

Control-IQ will come to Canada – details on timing

Starting in March 2021, in-warranty t:slim X2 users (ages 6+) will be able to update their pump to add Control-IQ technology via a remote software update, which will be free through the end of 2021 (December 31, 2021). New pumps will begin shipping with Control-IQ in “the first quarter of next year.”

Control-IQ and online training – a great, cheap combo to ensure patient education

According to Tandem’s Canadian website, the update to Control-IQ requires a prescription and completion of a 30 to 45-minute online training module, both of which are initiated through a request through the t:connect portal. Per the press release, current Canadian t:slim X2 users will receive email instructions for upgrading their pumps, which is effectively updating the algorithm, although the exact timing for the email instructions was not disclosed. Looking at the previous timeline for Basal-IQ in Canada, users began to receive the instruction emails in January, and the update launched in February, so we might expect that emails will begin in February ahead of the March 2021 Control-IQ update launch though this is speculation. We are not sure why it wouldn’t be possible to do this earlier, but it may just be the logistical work internally that is required.

Control-IQ and international expansion – moving beyond US, UK, South Africa

This approval fits into Tandem’s OUS expansion timeline discussed during the company’s early November 3Q20 call. During the call, CEO John Sheridan announced that “by year’s end, we anticipate Control-IQ will be available in more than half the countries outside the United States and look froward to broad availability.” As we reported in 2Q20, Control-IQ is now available internationally in the UK and South Africa, and Tandem has also received reimbursement approval in Germany, where, as of 2Q20, it was expected to begin marketing Control-IQ in 2H20. Given Mr. Sheridan’s 3Q20 predictions for expanded OUS rollout by the end of the year, we expect to hear similar announcements about other countries in the coming weeks.

AID (Automated insulin delivery) – A killer app, enabled by CGM

We look forward to hearing more how demand for pumps change with AID (automated insulin delivery). We believe that pumps have improved in important ways over time but nothing like as great as recent changes propelled by AID, made possible with CGM, the data from which makes the automation possible. In talking with patients and looking at dQ&A CGM data, it’s clear that the ability to have nights with so much better glucose, combined with days and nights with so much less hypoglycemia has been profound. Medtronic’s 670G was approved in 2016 by FDA and we will never forget that first result – an approval in an unprecedented three months!

  • Researchers for Tandem’s Control-IQ technology learned so much from patients in the IDCL closed loop trials, which were funded in part by NIH. The result of this important iDCL trial hit the New England Journal of Medicine to much acclaim in October 2019 (Close Concerns report, Tandem press release, NEJM article “Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes” and prestigious editorial “Toward Automated Insulin Delivery.”) This Tandem trial result that enabled over 90% time in range, an additional 2.6 hours in range, and near-perfect user surveys received wide, wide acclaim in the diabetes community of researchers, clinicians, engineers, all those working in and around automated insulin delivery, to say nothing of patients and their families.

  • It’s exciting to see Tandem’s AID, which has received such great responses moving to multiple geographies – we’ll be back with more as we receive answers to our questions and responses from our Canadian friends.

Close Concerns Questions:

  • How many Basal-IQ users are there in Canada? How many pump users are there estimated to be in Canada, how has growth been, and how much growth will this approval propel?

  • Multiple Tandem users in Canada greeted today’s news with celebration and they’d voiced interest in getting the upgrade sooner than March – is this four months extra time needed a result of logistics or documentation or something else?

  • How much might Tandem forecast pump demand to go up, with the “killer app” of being able to much better prevent hypoglycemia and hyperglycemia and to improve substantially time in range?

  • Can Tandem share any comments about the TypeZero algorithm and the degree to which it has helped gain new customers? What are the ways in which it is different from algorithms used by the 670G and the Loop algorithms? 

--by Katie Mahoney and Kelly Close