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Looping with BCDiabetes - consent & waiver for a minor

Dr. Tom Elliott, Medical Director of BCDiabetes recommends that automated insulin delivery (AID) systems, also known as Artificial Pancreas (AP) systems, the combination of an smart insulin pump, integrated CGM and interoperable automated glycemic controller (smartphone with the necessary software), be considered by all individuals living with Type 1 diabetes or Type 2 diabetes on multiple daily shots.  This is because the AP systems offer superior control and safety over conventional systems.  The primary obstacles to adoption of AP systems are cost, complexity & resistance to change.

This short URL, https://bit.ly/2QO2Xpk, links to all AP systems available in Canada currently.   

Health Canada has currently approved two retail AP systems the hardware components for which are not fully covered by BC Pharmacare

  1. Medtronic 670G & 770G (a tubed system that offers temp basal adjustment, & is covered by BC Pharmacare, though it's CGM the Guardian, is not covered by BC Pharmacare).
  2. Tandem pump running the TypeZero algorithm (a tubed system that offers temp basal and microbolus adjustment, pump not covered by BC Pharmacare, but CGM, the Dexcom G6 is covered by BC Pharmacare).

In the next 48 months Health Canada will likely approve two further retail AP systems:

  1. The Omnipod 5 system (a tubeless pump system that is covered by BC Pharmacare) in combination with a Dexcom G6 CGM (covered by BC Pharmacare) with experimental proprietary software (not yet approved by Health Canada)
  2. Ypsopump (a tubed pump that is covered by BC Pharmacare) in combination with a Dexcom G6 CGM (covered by BC Pharmacare) running with the TypeZero algorithm (approved by Health Canada for the Tandem pump (see above), but not for the Ypsopump).

The only AP system whose hardware components are covered by BC Pharmacare is the combination of the Omnipod pump with Dexcom G6 CGM

This consent and waiver covers use of a three experimental systems, Loop, androidAPS and freeAPSX (DIY smartphone apps) working with the Dexcom G6 CGM and the tubeless Omnipod pump, that are not Health Canada approved. The hardware components of these three systems (the Omnipod pump & Dexcom G6) are both covered by BC Pharmacare.

The two retail & three experimental AP systems referred to above are recommended and supported by BCDiabetes.  Because the three experimental AP systems are not-Health Canada approved prescriptions for them and their use are considered “off-label”.  Off-label prescriptions require a deliberate consenting process.  Hence this document.

On 2020-Jun-12 Tidepool, the commercial developer of Loop, submitted Loop for approval to the US Food and Drug Administration (FDA) using an observational study of 873 Loopers as its primary evidence (see http://bit.ly/loop_safety_study).  It should be noted that drugs & devices approved by the US FDA historically are approved by Health Canada after a further 18-24 month delay.  As of 20201-Sep-10 BCDiabetes had installed and supported 74 Loopers for 3+ months: their aggregate results can be seen at https://bit.ly/3jWo2Mx. No episodes of severe hypoglycemia were experienced in this cohort.

The rationale for off-label prescription of Loop, androidAPS & freeAPSX systems is that they offer equivalent or superior glucose control and quality of life compared to Medtronic & Tandem systems at a lower price (hardware covered by BC Pharmacare).   Loop is at least as safe as Medtronic & Tandem systems: Loop has been used safely by an estimated 10000 individuals since 2015 and by 74+ clients at BCDiabetes (as of 2021-Sep-10). For this reason BCDiabetes recommends Looping with the Omnipod pump and Riley link as first choice for its clients.  Similar data are now accumulating that androidAPS is equally safe and efficacious - witness the study of Gawrecki and colleagues 2021-Apr-5 see http://bit.ly/2Qs4zNS.  Because freeAPSX uses the same AP algorithm as androidAPS (openAPS) - it is assumed that freeAPSX is equally as safe and efficacious as androidAPS.

I, the undersigned, and parent/guardian of Minor (hereafter "my child") understand that the Loop & freeAPSX app and androidAPS (derived from github) the software driving my Omnipod pump based on CGM readings from a Dexcom G6 (or Freestyle Libre device) relayed via a radiotransmitter device ("Orangelink" or other similar device), are part of experimental projects known as “Loop”, "freeAPSX" and "androidAPS" respectively that are not approved by Health Canada.

I had planned to set up “Loop", "freeAPSX" or "androidAPS” myself using a standard DIY installation however given its complexity I consider that it is in my child’s best interests to have the installation done professionally at BCDiabetes.  I hereby, as guardian/parent, consent to my child being treated with the Loop, freeAPSX or androidAPS systems.

By installing the Loop, freeAPSX or androidAPS app on my child’s smartphone, or allowing the Loop, freeAPSX or androidAPS app to be installed on my child’s smartphone (or a phone provided for me by Dr.T.G. Elliott Inc, dba BCDiabetes) by employees of BCDiabetes I hereby assume full responsibility for running the entire system (“Looping with smartphone, Omnipod, Dexcom G6/Freestyle Libre, Orangelink & Loop app) and understand that I do so at my child’s own risk.  I understand that Loop and freeAPSX apps are shared by BCDiabetes with their clients through their Apple Developer TestFlight account: these apps have a shelf life of 90 days.  To provide continuity of app support BCDiabetes software engineers renew the apps every 75 days however approval by Apple is required for the new app to be released.  Apple has within its business powers the right to refuse or delay approval.  As such I understand that BCDiabetes does not guarantee access to updated/renewed Loop & FreeAPSX apps through their Apple Developer TestFlight account.  I understand and accept that at any time, potentially with no more than 14 days notice, these apps may no longer be available.  At that point I understand I will need to find an alternative insulin delivery system (retail or otherwise) to manage my child’s diabetes.  I understand that AndroidAPS is a good DIY option as it is not controlled by Apple.com - however use of Android APS would mean my child using an android phone.

Today's Date: October 17, 2021

 

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