COMMENTARY

The Artificial Pancreas Has Arrived in Canada: What to Expect

Harpreet S. Bajaj, MD, MPH

Disclosures

January 02, 2019

"Hey doc, when is the artificial pancreas coming to Canada?" This has been an oft-repeated question to Canadian physicians over the past 2 years.

Harpreet S. Bajaj, MD, MPH

And now, finally, Canadian healthcare professionals can respond in the affirmative with certainty. Exactly 2 years after the US Food and Drug Administration (FDA) surprised everyone in October 2016 by approving Medtronic's 670G in the United States on a priority review, Health Canada has allowed the use of this technological advancement north of the border—specifically for people with type 1 diabetes who are older than 7 years.

What can we expect when the first 670Gs start shipping out to Canadian soil in December 2018? To what degree will this "first artificial pancreas" be adopted in clinical practice? What challenges can Canadian consumers and healthcare professionals expect? Can any lessons be learned from experiences in the United States?

Pump Use in Canada

An estimated 300,000 Canadians live with type 1 diabetes.[1] However, pump use within the type 1 diabetes population in Canada is estimated to be less than half of the estimated utilization in the United States.

Although numerous reasons exist for the lower adoption of pumps in Canada, some reluctance from a patient perspective originates from a commonly held perception that pumps are very complicated devices and that fine-tuning the hourly basal insulin dose is a tedious and time-consuming job.

This specific challenge may be partially overcome with the first hybrid closed-loop (HCL) system (ie, the 670G). It is anticipated that even more automation will be achieved in the future—with second-generation automated pumps from Medtronic, Tandem-Dexcom, and Omnipod—and will overcome this barrier more comprehensively.

Whether this technology ever reaches a "plug-and-play" level of ease, however, appears to be a distant dream.

Do We Know What We're Getting?

The breadth of completed research appears robust, with additional publications[2,3,4,5] since the FDA approved this technology in 2016 on the basis of a single-arm comparison pivotal study.[6] The two biggest benefits consistently observed are a 5%-10% improvement in time in range and reduced hypoglycemia in favor of the 670G.

It's worth noting here that a multicenter, large (1500 participants), randomized controlled trial comparing the efficacy and safety of Medtronic's HCL system with three comparator arms (sensor-augmented pump without automation, insulin pump without sensor augmentation, and multiple daily insulin) is still ongoing.[7]

Lessons From Our US Neighbors

Canadians may also benefit from practical experiences in the United States that may help facilitate development of an easier template for new 670G starts.

For example, utilizing more aggressive adjustments for the insulin-carbohydrate ratio to avoid severe postmeal hyperglycemia and the HCL pump from kicking out of auto mode—with less fear of hypoglycemia between meals because this automated pump will pull back the corrections—is often touted as a necessary care step by US colleagues.

Also, with the new HCL system, the active insulin time setting may need to be adjusted down to about 2-2.5 hours. Because there is no programmed basal infusion during that time, the active insulin time needs to be a lot lower so that the automated basal insulin delivery can kick back in.

More important, both consumers' and providers' expectations are a bit clearer and have been moderated since the early hype in 2016-2017. We are no longer expecting the moon!

Who Should Be Using These?

This HCL system may be best suited for patients who are trying hard but failing to get adequate glucose control or who are suffering unpredictable lows despite their best efforts (and there are many such patients in every diabetes practice).

This system is probably not ideal for patients on either end of the spectrum of self-care behavior (ie, completely apathetic or superengaged and hypervigilant). Note that targets come factory-set and cannot be adjusted or individualized on the current version of the 670G.

If you had not guessed it by now, Medtronic's current HCL has no bolus automation (surprise, surprise!), meaning that the patient still needs to be capable and willing to count carbs for prandial insulin adjustment.

The need for frequent calibration of the HCL system means more fingerstick glucose checks, not fewer. And there still exists the need to learn manual basal insulin adjustments as a backup, for those times when the HCL system kicks out of auto mode into manual mode.

Anticipated Challenges

Canadians, both providers and consumers, can expect a rather steep learning curve for the 670G initially. If you don't anticipate spending a few hours learning the nitty-gritty of the new system, you may find that this technology doesn't work for you and your patients.

It should be noted that the reports generated by the HCL system are quite different from the usual CareLink software data that you may be more familiar with, and will require a change in your clinical approach to insulin adjustments.

Cost and coverage challenges will remain in place for the foreseeable future, because no provincial coverage is expected for the 670G, at least for the time being.

Another outstanding monetary question will have to be dealt with once the automated insulin delivery utilizing second-generation technologies in the not-too-distant future becomes more precise and accurate. The question relates to whether Canadians with type 1 diabetes using these automated systems will be eligible for the disability tax credit, which requires documentation that the applicant spends at least 14 hours per week on activities specified by the Canadian Revenue Agency to be directly related to administering insulin.[8]

Use in Type 2 Diabetes

Cost and coverage notwithstanding, it is conceivable that future automated insulin pumps will begin to be utilized in Canada even among certain people with type 2 diabetes (eg, those on multiple daily insulin). Traditionally, Canada has seen far lower adoption of pumps in this patient population compared with that observed in the United States.

The incorporation of technology has already percolated into management of type 2 diabetes recently in the form of continuous/flash glucose monitoring, and this may pave the way for future use of "artificial pancreas" insulin delivery systems in type 2 diabetes.

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