search_index.json

[["index.html", "BC Diabetes Looping Agreement 1 How To Use This Guide 1.1 The Sidebar 1.2 The Toolbar", " BC Diabetes Looping Agreement BC Diabetes 2022-08-07 1 How To Use This Guide 1.1 The Sidebar 1.2 The Toolbar The pale grey icons at the top of the right-hand pane are the Toolbar buttons. They are fixed at the top of the page and are always available as you scroll. Starting at the top left, they are: 1.2.1 Show/Hide The first button on the toolbar can toggle the visibility of the Sidebar. You can also tap the S key on your keyboard to do the same thing. If you close the Sidebar, it will remain closed the next time you open the book. 1.2.2 Search The second button on the toolbar is the Search button, keyboard shortcut F (Find). Click the button to see a Search box. As you type in the box, you will see only sections that match the search keyword. Use the Arrow Keys [Up/Down] to highlight the previous/next match in the search results. Click the Search Button again (or hit F outside the Search Box). The search keyword will be emptied and the Search box will be hidden. 1.2.3 Theme settings The third button on the toolbar is for Font/Theme settings. You can: Change the font size (bigger/smaller), the font family (serif/sans serif), and the theme (White, Sepia, or Night). 1.2.4 Downloads The Download icon button lets you download files of available types. Downloadable file types (PDF, EBOOK) are displayed in a drop-down menu. Click the type of file you want. If more than one file of that type is available, they will be shown. Click the specific file or [ALT/OPTION + CLICK] to select more than one. 1.2.5 Sharing On the right end of the toolbar are buttons to share the link on social media sites such as Twitter, Facebook, and Linkedin. 1.2.6 Information The Information Button (i) lists keyboard shortcuts available to navigate the document. "],["initial-settings.html", "2 Initial Settings 2.1 SERVICES 2.2 CONFIGURATION 2.3 Target Ranges 2.4 Autotune 2.5 Connect To Apple Health", " 2 Initial Settings The following Settings are listed in order of appearance in the FAX-ng app. If not mentioned, leave the existing Default Settings. Click the Cog Wheel (bottom right of the FAX-ng screen) 2.1 SERVICES 2.1.1 Nightscout URL - Your Nightscout URL ( NO / at the end) Password - Your API Secret as the password Connect - Tap –> Connected! Allow Uploads - Enable 2.1.2 CGM Type - Dexcom G6 Transmitter ID - Enter current 2.1.3 Notifications Your choice, e.g. All turned Off, set High —> 10 2.2 CONFIGURATION 2.2.1 Preferences 2.2.1.1 FREEAPS X Recommended Insulin Fraction > 2 2.2.1.2 OPENAPS MAIN Settings Insulin Curve - Set to the type of insulin you are using Max IOB - raise to 10 2.2.1.3 DYNAMIC SETTINGS Dynamic CR - Enable Adjust Basal - Enable 2.2.1.4 OPENAPS SMB SETTINGS Enable SMB … options - Enable All Enable UAM - Enable Max Delta-BG Threshold SMB > 0.3 SMB Interval > 1 Bolus Increment > 0.05 ONLY if using Omnipod 2.2.1.5 OPENAPS TARGETS SETTINGS High TempTarget Raises Sensitivity - Enable Low TempTarget Raises Sensitivity - Enable Sensitivity Raises Target - Enable Resistance Lowers Target - Enable 2.2.2 Basal Profile Copy from old Loop, FAX or Nightscout,, or as advised. Example Basal Profile in Nightscout Example Basal Profile listed in Nightscout profile 2.2.3 Insulin Sensitivities Use Autotune value 2.2.4 Carb Ratios Use Autotune calculated value 2.3 Target Ranges Set to whatever range with which you are comfortable Lower range is the one that matters e.g. 5.5 - 5.5, 24/7 2.4 Autotune Enable 2.5 Connect To Apple Health Enable You must also Enable Read and Write to FreeAPS X NextGen in Apple Health: iPhone Settings –> Health –> FreeAPS –> Blood Glucose "],["add-pump.html", "3 Add Pump 3.1 If You Are Upgrading From FreeAPS X 3.2 If You Are Upgrading From Loop to FAX-ng 3.3 Close Loop", " 3 Add Pump 3.1 If You Are Upgrading From FreeAPS X Only one pump at a time can be controlled by FreeAPS-X or FAX-ng, so to add a pump to a new setup you must first Disable OrangeLink/RileyLink in the old pump setup. 3.2 If You Are Upgrading From Loop to FAX-ng ATTENTION: You must FIRST disconnect RileyLink/OrangeLink/EmaLink from Loop.app BEFORE trying to connect a new Omnipod to FAX-ng. At a scheduled or unscheduled Omnipod change: While in Loop Tap Replace Pod BEFORE disconnecting your RileyLink Settings > OmniPod screen (Also available from Pump/Pod icon in Loop top Header) Turn RileyLink switch OFF RileyLink Green LED will turn off Close the Loop App Swipe Up Loop icon on Home Screen Back in FAX-ng Select Omnipod in Settings > Pump RileyLink should be recognised immediately Turn RileyLink ON Fill a new pump or OmniPod, attach to body Start New Pod 3.3 Close Loop Enable "],["fine-tuning-using-your-log-files.html", "4 Fine-Tuning Using Your Log Files 4.1 Copying Your Log Files to Your Mac 4.2 Setting UAMSMB/SMB Limitations", " 4 Fine-Tuning Using Your Log Files 4.1 Copying Your Log Files to Your Mac You must first create and copy FreeAPS-ng log files from your iPhone to your Mac computer. Tap Share logs at the bottom of Settings in FAX-ng This will create two log files, log.txt and log_prev.txt, and open a screen allowing you to transfer them by a variety of methods. Save these files on your Mac in a Folder of your choice Leave the Folder window open on your Desktop 4.2 Setting UAMSMB/SMB Limitations 4.2.1 Safety Limiters The following Settings act as “safety limiters”: Max UAMSMB Basal Minutes Max SMB Basal Minutes Autosens Max Autosens Min They do they not affect calculations except by putting up fences. The primary focus on a new setup is to have initial Settings* so that the system is immediately able to function adequately using its default calculations. But if your Basal Minutes is set to 30 and your Basal Rate is .1, and the app wants to give you an SMB of 2U, the Basal Minutes setting will limit it to .5U at a time, and your blood sugar will be high forever. So you will want to increase Basal Minutes to a value that allows the algorithm to do its job. The ideal is to create Settings that allow 95% of any UAMSMB/SMB calculation made by FAX-ng to influence insulin delivery. For this we need to ensure that: SMB is not limited by maxUAMSMBBasalMinutes SMB is not limited by maxSMBBasalMinutes Dynamic ISF limited by autosens_max setting: 1.3 (1.3) To understand SMB and its limitations factors, you can read: Understanding Super Micro Bolus (SMB) in the OpenAPS documentation. 4.2.2 Open Terminal on Your Mac The Terminal application is in Applications > Utilities > Terminal 4.2.2.1 SHORTCUT to open Terminal Click on the Desktop in Finder Hold the [COMMAND] key then tap the [SPACEBAR] Start typing terminal when the Spotlight Search bar opens Press [RETURN/ENTER] to open the Terminal application 4.2.2.2 Change focus to the Log File Directory Type cd [SPACE] in Terminal Switch to Finder Drag the small Folder icon where you saved the log files, into the Terminal window path/to/the/log/files/folder will appear next to cd Press [ENTER/RETURN]. This will change Terminal to the log file directory. You can type ls then tap [RETURN/ENTER] to list the log files. The following commands will now work correctly. 4.2.3 Find and Compare The Ratio of SMB-Limited Lines First, find find the total number of lines from the log pertinent to each. Copy and paste the first line of each command (below), after the $ prompt. The first line is the command, the second the returned result: grep maxUAMSMBBasalMinutes log.txt | grep limited | wc -l 114 Then find the number of lines that are SMB-limited: grep maxUAMSMBBasalMinutes log.txt | grep "SMB limited" | wc -l 57 Compare the two results. If the number of limited lines is more than 5% (in the above examples it obviously is), you need to adjust maxUAMSMBBasalMinutes, guided by these log reports. Sort the result by calculated units (the last value on the line): grep maxUAMSMBBasalMinutes log.txt | grep "SMB limited" | sort -n +20 Scroll through the search results to see how much the algorithm is limiting insulin delivery. The overall idea is to “ignore” the extreme SMBs. In the log file, you will see lines similar to: DEV: JavaScript log: SMB is not limited by MaxUAMSMBBasalMinutes. ( insulinReq: 0.53U ) DEV: JavaScript log: SMB limited by maxUAMSMBBasalMinutes [ 60m ]: 1.5U ( 6.28U ) There will be entries for both maxUAMSMBBasalMinutes and maxSMBBasalMinutes Optimally, you want to have more “not limited” lines then limited, with limited lines being less then 5% of all of the lines. If they are less than 5% of all lines, you don’t need to change your settings. To adjust maxUAMSMBBasalMinutes to reduce the percentage of lines that are limited, look for the line that represents about the mid-way of limited values. For example, if you have something like: DEV: JavaScript log: SMB limited by maxUAMSMBBasalMinutes [ 60m ]: 1.5U ( 6.28U ) DEV: JavaScript log: SMB limited by maxUAMSMBBasalMinutes [ 60m ]: 1.5U ( 5.72U ) DEV: JavaScript log: SMB limited by maxUAMSMBBasalMinutes [ 60m ]: 1.5U ( 6.1U ) Use the entry with 6.1U as your adjustment point, with the formula: 60m * ( 6.1 / 1.5 ) = 240 And use the rounded results for your new value in maxUAMSMBBasalMinutes. Do the maths and up your UAMSMB basal minutes by that amount. For example: the algorithm bolused 1U insulin when it says it really wanted to bolus 3U, so increase UAMBasalMinutes by 3x in Settings. If you need to adjust, there are going to be more lines then the above to work with, but the value in parenthesis is what the system has calculated you require in the way of insulin, and the value outside is the limit BASED ON BasalMinutes. The 1.5U will vary depending on time of day, as its determined by your Basal Rate at the time of calculation. When you make the change, give it 24 hours before checking and adjusting again. 4.2.4 An Easier Way for the Rest of Us Heres a much easier way for non-technical people: * Email log files to yourself * Open log_prev.txt * Press [CONTROL/COMMAND] + F to perform a search * Enter e.g. SMB is limited by maxUAMSMBBasalMinutes into the Search field. * Press [RETURN/ENTER] Search for either is limited or is not limited to get the numbers for both. If the [limited]/[is not limited] x 100 is less than 5 (5%), then dont change anything. 4.2.5 Checking The Results To check this (except the first day or so), run the above commands on the log_prev.txt file, which reports the previous 24-hour period. Leave it run for a full day before rechecking. If everything else is set up correctly for you, these SMB maximums wont be needed in the future. But now you can know for sure that they are based on the results returned in your log files. "],["adjustment-factor-autosens.html", "5 Adjustment Factor (AutoSens) 5.1 Ballpark Formula", " 5 Adjustment Factor (AutoSens) Settings –> Preferences –> Dynamic Settings –> Adjustment Factor Adjustment Factor is a multiplier that impacts insulin delivery. It determines the aggressiveness of the DynamicISF algorithm, and it tends to be person-specific. Basically, it’s determining how sensitive/resistant you are compared to your baseline. An AutoSens value of 1 means that your sensitivity is what the system expects. More than 1 means that you’re needing more insulin than your baseline Less than 1 means you are currently more sensitive and need less insulin The default is set at 1, which means that there is no change from those Settings values that affect insulin delivery. A full explanation of AutoSens can found in the OpenAPS documentation. 5.1 Ballpark Formula There is a formula for deriving an approximate number to begin with: adjustmentFactor = 277700/TDD * BG_target * (18 * 18) * StaticISF Total Daily Delivery (TDD) can be found by tapping the green circle at the top of the main FAX-ng page. There are three numbers in the purple area: TDD, Weighted Average (Wavg), and 7day. Use the TDD value. BG_Target is whatever you have chosen for your target, e.g. 5.5. Use the Autotune value for StaticISF Settings –> Configuration –> Autotune Autotune runs automatically every day, but you may want to run it now if it hasn’t run for a while. The Autotune value also can be found in Settings -> Configuration –> Insulin Sensitivities –> Autotune –> Calculated Sensitivity Using some example numbers, the AdjustmentFactor will be: 277700 / ( 2.31 * 78.75 * 5.5 * ( 18 * 18 ) * 2.31) = 0.856 It isn’t 100% accurate, but it gets you into the ballpark range, and you can tweak up or down from there. "],["bolusing-for-meals.html", "6 Bolusing for Meals 6.1 Rule-of-Thumb Meal Bolusing 6.2 Let FAX-ng Do Its Work", " 6 Bolusing for Meals FreeAPS (FAX) doesnt actually give meal bolus recommendations as does Loop. Heres what the Meals section of LoopAndLearn FreeAPS docs recommends: The built-in function to give a bolus is not a bolus calculator in the same way as Loop has one, so don’t expect it to give you enough insulin. It takes the insulinReq calculation and uses it to provide a bolus estimate. The insulinReq value is calculated based on a number of prediction curves, and when carbs are added, it mediates the effect of carbs with the other curves. It’s not a bolus calculator. The insulinReq value is not necessarily as much insulin as the normal meal bolus would be (it’s conservative for safety reasons). The recommendation with oref1 is to bolus 60%-75% of required meal bolus and leave the algorithm to deal with variation in absorption. This is the way most people use it. 6.1 Rule-of-Thumb Meal Bolusing Rather than pull out a calculator, one pre-bolus strategy might be to form a rule-of-thumb scale for yourself like the following. You should make your own based on your needs and Carb Ratio (CR): Small meal 20g or less –> 2U Medium-size meal 20g-40g –> 3U Big meal 40g or more –> 4U Your scale should be based upon your carb ratio and the % of upfront bolus that you prefer. For example, with a Carb Ratio of 10, the above meal boluses would provide a: * 100% upfront bolus for 20g * 75% upfront bolus for 40g, and * 67% upfront bolus for 60g 6.2 Let FAX-ng Do Its Work With an appropriate pre-bolus and Settings, you should NOT need to issue manual boluses after your meal. This may be a difficult task coming from Loop! If you used automatic bolus with Loop or the FreeAPS fork, youll find Temp Basal a little slower than you are used to, but its worth taking the time to test and adjust your settings before you turn on SMB/UAM. Observe for a few days and make adjustments as needed so that you wont have to issue correction meal boluses. (Thanks to LoopAndLearn for this.) "],["appendices.html", "7 Appendices 7.1 Appendix A: Acronyms 7.2 Appendix B: Settings 7.3 Appendix C: Preferences", " 7 Appendices 7.1 Appendix A: Acronyms BG Blood Glucose BGI Blood Glucose Impact CI Carb Impact COB Carbs On Board CR Carb Ratio ICR Insulin to Carb Ratio IOB Insulin On Board ISF Insulin Sensitivity Factor ISR Insulin Sensitivity Ratio RIF Recommended Insulin Fraction SMB Super Micro Bolus SR Sensitivity Ratio UAM Unannounced Meals ZT Zero-Temp 7.2 Appendix B: Settings 7.2.1 FREEAPS X V(version) Closed Loop 7.2.2 DEVICES Pump Omnipod Pod Settings Expires Pod Active Clock Bolus Delivery Basal Delivery Alarms Reservoir Insulin Delivered CONFIGURATION Suspend Delivery Disable Confirmation Beeps Disable Automatic Bolus Expiration Reminder Change Time Zone Insulin Type Replace Pod DEVICES RileyLink/OrangeLink/EmaLink DIAGNOSTICS Read Pod Status Play Test Beeps Read Pulse Log Test Command POD DETAILS Assigned Addresses Lot PI Version PM Version 7.2.3 SERVICES Nightscout Nightscout Config Nightscout URL Nightscout Secret Key Connect Delete Allow uploads LOCAL GLUCOSE SOURCE Use local glucose server Port Backfill glucose CGM Type TRANSMITTER ID CALENDAR Create events in calendar OTHER Upload glucose to Nightscout 7.2.4 Apple Health Connect to Apple Health 7.2.5 Notifications GLUCOSE Show glucose on the app badge Always Notify Glucose Also play alert sound Also add source info Low High OTHER Carbs Required Threshold 7.2.6 CONFIGURATION Preferences are in Appendix C: Preferences 7.2.7 Pump Settings DELIVERY LIMITS Max Basal Max Bolus DURATION OF INSULIN ACTION DIA Save on Pump ### Basal Profile SCHEDULE Rate(s) Add Save on Pump 7.2.8 Insulin Sensitivities AUTOTUNE Calculated Sensitivity AUTOSENS Sensitivity Ratio Calculated Sensitivity SCHEDULE Rate(s) Add Save 7.2.9 Carb Ratios AUTOTUNE Calculated Ratio SCHEDULE Ratio(s) Add Save 7.2.10 Target Ranges SCHEDULE Range(s) Add Save 7.2.11 Autotune Use Autotune Last Run Run now Carb Ratio Sensitivity BASAL PROFILE Rate(s) Delete Autotune data 7.2.12 DEVELOPER Debug options 7.2.13 Animated Background 7.2.14 Share logs 7.3 Appendix C: Preferences 7.3.1 FREEAPS X Glucose Units Remote control Recommended Insulin Fraction Skip Bolus screen after carbs 7.3.2 OPENAPS MAIN SETTINGS Insulin curve Max IOB Max COB Max Daily Safety Multiplier Current Basal Safety Multiplier Autosens Max Autosens Min 7.3.3 DYNAMIC SETTINGS Enable Dynamic ISF Enable Dynamic CR Adjustment Factor Use Logarithmic Formula Weighted Average of TDD. Weight of past 24 hours: Adjust Basal 7.3.4 OPEN APS SMB SETTINGS Enable SMB Always Max Delta-BG Threshold SMB Enable SMB with COB Enable SMB With Temptarget Enable SMB After Carbs Allow SMB With High Temptarget Enable UAM Max SMB Basal Minutes SMB DeliveryRatio SMB Interval Bolus Increment 7.3.5 OPENAPS TARGETS SETTINGS High Temptarget Raises Sensitivity Low Temptarget Lowers Sensitivity Sensitivity Raises Target Sensitivity Lowers Target Advanced Target Adjustments Exercise Mode Half Basal Exercise Target Wide BG Target Range 7.3.6 OPENAPS OTHER SETTINGS Rewind Resets Autosens Use Custom Peak Time Insulin Peak Time Skip Neutral Temps Unsuspecting If No Temp Suspend Zeros IOB Bolus Snooze DIA Divisor Min 5m Carbimpact Autotune ISF Autotune Faction Remaining Carbs Faction Noisy CGM Target Multiplier 7.3.7 USE AUTO ISF Enable AutoISF 7.3.8 AUTOISF SETTINGS FORGET ABOUT THESE IF AUTO ISF ISS TOGGLED OFF * Enable Floating Carbs * Enable AutoISF with COB * Enable BG acceleration in AutoISF 2.2 * AutoISF HourlyMaxChange * AutoISF Max * SMB Max RangeExtension * SMB DeliveryRatio BG Range * SMB DeliveryRatio BG Minimum * SMB DeliveryRatio BG Maximum * ISF weight while BG accelerates * ISF weight while BG decelerates * AutoISF Min * ISF Weight for higher BGs * ISF weight for lower BGs * ISF weight for higher BG deltas * Enable always postprandial ISF adaption * ISF weight for postprandial BG rise * Duration ISF postprandial adaption "],["bc-diabetes-looping-agreement.html", "8 BC Diabetes Looping Agreement 8.1 Background 8.2 What We Believe 8.3 Approved AP Systems 8.4 This Consent and Waiver 8.5 Agreement", " 8 BC Diabetes Looping Agreement Informed Consent and Waiver for Adults (18 years and older) Dr. Tom Elliott, Medical Director of Dr. T.G. Elliott Inc. (BCDiabetes) https://w.smrtwvr.com/w/5fc54955413f2/web/ 8.1 Background Diabetes causes the level of glucose (sugar) in your blood to become too high. It happens when your body cannot produce enough of a hormone called insulin, which controls blood glucose. The advent of Artificial Pancreas Systems (APS, also known as Automated Insulin Delivery systems or AID) has provided the potential to significantly improve diabetes management and quality of life among people living with Type 1 and Type 2 diabetes in real-life conditions. Artificial Pancreas Systems (APS or APSs) are the combination of a smart insulin pump, integrated CGM and interoperable automated glycemic controller (typically a smartphone with the necessary apps). APSs are sometimes called closed-loop systems, because they work near-automatically, with minimal user input. When properly managed, APSs offer eligible patients with Type 1 diabetes or Type 2 diabetes superior glycemic control and safety over conventional treatments. APSs have been in use since 2008 for people living with Type 1 or Type 2 diabetes, but until 2018 these were all experimental. Treatments and devices are called experimental when they have not been fully approved by a national regulatory agency. In Canada this agency is called Health Canada; in the United States the agency is called the FDA; in Europe the agency is called the EMA. Currently a number of APSs are available but some are still experimental including all Do-it-Yourself (DIY) APSs, those that are not solely commercially manufactured, produced, and implemented. If you are reading this document you may be considering using a DIY APS. All DIY APSs are still experimental. When a drug or device is approved for medical use by the Food and Drug Administration (FDA) of the United States or Health Canada, the manufacturer produces a label to explain its use. Once a device/medication is approved by the FDA or Health Canada, physicians may prescribe it according to the label or use it off-label for other purposes. They may only prescribe it off-label if they are well-informed about the product, base its use on firm scientific methods and sound medical evidence, and maintain records of its use and effects. Although both the **Omnipod* Eros* and Dash pumps and Dexcom G6 CGM are individually approved by Health Canada, the FDA and the EMA, their use together in a DIY APS is off-label and the entire DIY APS is considered experimental. This is because the software driving DIY APSs is not approved by any agency. 8.2 What We Believe BCDiabetes believes that it should continue to offer people who use APSs, either DIY or commercial systems, the care and support they deserve and to which they are entitled. BCDiabetes cannot recommend the use of DIY APSs because no DIY APS is currently approved by any regulatory agency, including Health Canada. BCDiabetes must ensure that people with diabetes who are using, or planning to use a DIY APS, do so at their own risk. This is because DIY APSs, no matter how sophisticated they appear, are still considered experimental. These DIY closed-loop systems have typically been built by people with diabetes or parents of children with diabetes, for their personal use (or that of their children). Safety is a major consideration for people building and using these systems. People intending to use DIY APSs should be aware that they do this at their own risk, they may not receive support from their healthcare professional with any technical issues and that liability is unclear if there is a malfunction, error or problem. People intending to use DIY APSs should be competent and confident in optimizing their diabetes management using an insulin pump and CGM or flash glucose monitoring device. People intending to use a DIY APS can access support from the online DIY technology community for advice and troubleshooting. However, they must be aware that this advice is not regulated and they do so at their own risk. 8.3 Approved AP Systems There are currently two commercial APSs approved by Health Canada (and three or more approved by the FDA and the EMA) some of which may not be fully covered by BC Pharmacare or private or public drug insurance providers. This link describes all insulin pump systems, including APSs available in Canada. Medtronic 670G and 770G tubed system that currently offers temp basal adjustment. The pump and tubing are covered by BC Pharmacare but the Medtronic Guardian 3 CGM is not covered by BC Pharmacare. Tandem T-slim Control IQ tubed system that offers temp basal and microbolus adjustment: the Dexcom G6 CGM is covered by BC Pharmacare but the Tandem T-slim pump itself is not covered by BC Pharmacare. Health Canada is currently considering two other commercial APS submissions: The Omnipod 5 system tubeless pump system (the pump of which, the **Omnipod Dash, is covered by BC Pharmacare and the CGM of which, the Dexcom G6* CGM, is also covered by BC Pharmacare) with experimental proprietary software (approved by the FDA in 2022-May). The Ypsomed tubed system (the pump of which, the Ypsopump, is covered by BC Pharmacare and the CGM of which, the Dexcom G6 CGM, is also covered by BC Pharmacare) with experimental CAMAPS software (approved by the EMA in 2021). 8.4 This Consent and Waiver This consent and waiver covers the experimental use of three experimental software systems: Loop, freeAPS X and androidAPS (DIY smartphone apps, together Closed Loop Apps) that work in conjunction with approved devices like the Dexcom G6 CGM and the tubeless Omnipod insulin pump. The Closed Loop Apps are not approved by Health Canada, the FDA or the EMA. However, Loop was submitted to the FDA for approval on June 12, 2020 by Tidepool (a 501(c)(3) nonprofit organization) based on an observational study of 873 Loopers as its primary evidence. In early 2021 Lum and colleagues described self-reported outcomes for 553 Loopers. AndroidAPS was shown to be safe and efficacious in a study of 12 subjects by Gawrecki and colleagues 2021-Apr-5 – because freeAPSX uses the same AP algorithm as androidAPS (openAPS) – it is assumed that freeAPSX is equally as safe and efficacious as androidAPS. As of 2022-Jul-26 BCDiabetes has installed and supported 171 Type 1 clients with Loop (n=58), androidAPS (n=12) and freeAPSX (n=101) for 3+ months with no episodes of severe hypoglycaemia or DKA and average improvements in Time in Range and A1c of 19% and 0.7% respectively accompanied by significant reductions in Diabetes Distress and Fear of Hypoglycemia. However, the number of systems installed and supported and the related data remain limited. 8.4.1 Hardware Components The hardware components of these three Closed Loop App systems (the Omnipod pump and Dexcom G6) are both covered by BC Pharmacare and approved by Health Canada. BCDiabetes has observed through its support of patients using the experimental Closed Loop App APSs that these Closed Looped App systems offer equivalent or superior glucose control/incidence of severe hypoglycaemia and quality of life when compared to Medtronic and Tandem systems approved by Health Canada and the Omnipod 5* FDA-approved system at a lower price (hardware covered by BC Pharmacare). For these reasons, BCDiabetes offers to support patients wishing to use Close Loop Apps with the Omnipod pump and Riley link. 8.4.2 Possible Risks Possible risks relating to use of all APSs, including the Closed Loop App APSs, include the risk of infection, irritation and/or slight discomfort at the points of insertion for the Dexcom G6 sensors and Omnipod patch pumps; certain side effects associated with participants’ medical condition and their AID therapy; hypoglycaemia; and hyperglycaemia. 8.5 Agreement I hereby consent to treatment with a Closed Loop App APS and to receive services and advice from BCDiabetes with full knowledge and assumption of all associated risks. I hereby grant BCDiabetes (as well as its directors, officers, employees, insurers, agents, shareholders, affiliated corporations, predecessors, successors, beneficiaries and assigns) a full, final and complete release and discharge from any and all past, present or future complaint, demand, claims, causes of action, suits, rights, damages, losses, liabilities and costs of any nature and kind whatsoever (including for personal injury and death), howsoever arising, whether currently known or unknown, resulting from, arising out of or relating to, directly or indirectly, all services and advices rendered by BCDiabetes, including in connection with the use of any of the Closed Loop Apps. By installing a Closed Loop App on my phone (or a phone provided to me by BCDiabetes) with the assistance of BCDiabetes employees, I, the undersigned, hereby: Confirm that I had otherwise planned to set up a Closed Loop App myself using a standard DIY installation however given its complexity I consider that it is in my best interest to have the installation done professionally at BCDiabetes; Understand the nature and anticipated effect of what is proposed including the significant risks and Health Canada approved alternatives available have been explained to me and I am satisfied with these explanations and I have understood them; Understand that the Dexcom G6 and the Omnipod insulin patch pump are both approved by the FDA and Health Canada for the treatment of Type 1 and Type 2 diabetes in patients 2 years old and older. Wish to have a Closed Loop App configured and installed on my personal phone in order to treat my Type 1 or Type 2 diabetes and I confirm that I understand the risks of this experimental treatment technology and the off label use of the Dexcom G6 and the Omnipod insulin pump and I am willing to accept the potential risks that my physician has described and discussed with me. Acknowledge that there may be other, unknown risks relating to the use of the Closed Loop Apps; Understand that the Closed Loop Apps, the software driving my Omnipod pump based on CGM readings from a Dexcom G6 (or Freestyle Libre device) relayed in some cases via a radio transmitter device (Orangelink or other similar device), are part of experimental projects known as Loop, freeAPSX and androidAPS respectively and are not approved by Health Canada; Assume full responsibility for running the entire system (Looping with smartphone, Omnipod, Dexcom G6/Freestyle Libre, Riley Link and Loop app) and understand that I do so at my own risk; Understand that the iOS Closed Loop Apps are shared by BCDiabetes with their patients and clients through BCDiabetes Apple Developer TestFlight account where the Closed Loop Apps have a useful life of 90 days. To provide continuity of app support by BCDiabetes, software engineers renew the Closed Loop Apps developer license every 75-80 days, provided however that approval of Apple is obtained in order for a new app to be released. Apple has the right to refuse or delay approval of a release, which could interrupt renewal or access to the Closed Loop Apps at expiry through TestFlight. As such, I understand that BCDiabetes does not guarantee access to updated/renewed iOS Closed Loop Apps through their Apple Developer TestFlight account; Understand and accept that, at any time without notification, the Closed Loop Apps may no longer be available without prior notice; In the event Close Loop App access is interrupted or canceled, I understand that I will need to immediately revert to an alternative insulin delivery system (retail or otherwise) to manage my diabetes or build the app myself from source code; Agree not to copy (except for reasons of personal secure backup) or share this Closed Loop Apps with any other individual or entity without the express written consent of BCDiabetes. 8.5.1 Individual Patient Data (IPD) Sharing Statement The datasets generated during and/or analyzed during the patient use of any Closed Loop Apps supported by BCDiabetes will be stored in a secure non-publicly available cloud repository maintained by Google Canada. With the patients written consent, the data collected during the use of the Closed Loop Apps will also be added to your electronic medical record at BCDiabetes. All the datasets generated during and/or analyzed during the use of the Closed Loop Apps will remain confidential to the extent provided by law. Patients will only be identified by a code number. The key to the code linking participants to their data will be kept by the BCDiabetes. BCDiabetes could forward your coded data to the DIYAID community for the purpose of improving algorithms. BCDiabetes could also forward your coded data to healthcare authorities (e.g., Health Canada) for the purpose of assessing the benefits and limitations of different AID systems. However, BCDiabetes and any entities who receive the research data will respect the confidentiality rules in effect in British Columbia and Canada regardless of the country to which your data may be transferred. The data will be stored for at least 7 years beyond your last appointment with BCDiabetes as required by the laws of British Columbia. 8.5.2 Governing Law The Parties acknowledge and agree that the execution of this Informed Consent has not been induced by, nor do the Parties rely upon, any representations that are not expressly incorporated into this Informed Consent. The Parties hereby agree that their relationship and the resolution of any and all disputes arising therefrom, including any issues related to this Informed Consent, shall be governed by and construed in accordance with the laws of the province of British Columbia and the laws of Canada applicable therein. 8.5.3 Jurisdiction The Parties hereby acknowledge that the services will be provided in the province of British Columbia and that the Courts of the province of British Columbia shall have sole and exclusive jurisdiction to entertain any complaint, demand, claim, cause of action or suit whatsoever arising out of all services and advices rendered by BCDiabetes, including in connection with the use of any of the Closed Loop Apps, as well as of this Informed Consent. The parties hereby agree that if either of them commences any such legal proceedings they will only be commenced in the province of British Columbia and hereby irrevocably submit to the exclusive jurisdiction of the Courts of the province of British Columbia. 8.5.4 Consent I have read the foregoing information, or it has been read to me. I have had the opportunity to ask questions about it and any questions that I have asked have been answered to my satisfaction. I consent voluntarily to use the Closed Loop Apps. Dated: July 30, 2022 "],["404.html", "Page not found", " Page not found The page you requested cannot be found (perhaps it was moved or renamed). You may want to try searching to find the page's new location, or use the table of contents to find the page you are looking for. "]]