Автономный замкнутый контур
The main attraction of Full Closed Looping FCL is that it has the potential to mimic an artificial pancreas and make daily management easier without having the need to bolus for meals.
Whilst hybrid closed loop („HCL“) is algorithm based, it still requires the user to manually deliver boluses prior to meals. As a result, the loop may go into a temporary shut-off (temporary zero basal) to prevent over delivery of insulin.
In FCL mealsize-related bolus are no longer required: leave it to the algorithm! AAPS may allow without the user giving any bolus, and without making carb inputs, in a mode called ‘un-announced meals’ (‘UAM’). UAM allows AAPS to better tolerate incorrect carb inputs by being more aggressive.
Чего ожидать?
There are many published studies on the favourable results FCL can achieve. For further reading refer to the following:
National Library of Medicine, PubMed First Use of Open-Source Automated Insulin Delivery AndroidAPS in Full Closed-Loop Scenario: Pancreas4ALL Randomized Pilot Study;- ClinicalTrials.gov National Library of Medicine, Clinical Trial Feasibility and Safety Study of the Automated Insulin Delivery Closed Loop System Pancreas4ALL (ASAP)
Success for FCL requires the user to:
check whether they met the FCL requisites;
set up Automations that are tailored for their daily management’s needs; and
fine tune and adjust the AAPS settings (notably Automations).
General considerations why (not to) move from HCL to FCL
FCL is not for everyone:
Some FCL users achieve TIR (70-180) around 90% and HbA1c under 6%, however other users prefer tighter control. Notably, minimising values over 140 mg/dl at diets with rapid carbs probably requires pre-bolusing.
AAPS tuning can be challenging. It is not for those users who feel overwhelmed AAPS. You will need to dedicate a few weeks in order to adjust and fine tune your FCL. Investing such time can yield better results and BG control.
Meal management may become easier, however exercise can still be challenging in FCL. Most of us like to limit sports snacks in an attempt to control body weight.
Difficulties still remain to establish a FCL for kids (discussed below).
Правильно настроенный гибридный замкнутый цикл
It is advisable to first establish a well-tuned HCL before considering the transition to FCL. Success with FCL requires a highly personalised individualised tuning of the user’s setting so that AAPS can give insulin to closely mimic YOUR successful hybrid closed loop mode.
FCL requires the user to set up and tune their Automations. However the user must have a confident understanding of their insulin management needs before embarking on FCL. Errors can be masked with counter-errors. This can create an unstable FCL system, and make it hard to later correct. You should expect to reach a comparable %TIR with your FCL as you see today in your HCL.
FCL is a DIY set up of Automations determined by the user by analysing their data from both their successful HCL and initial FCL experience when tuning your settings.
Инсулины короткого действия (Lyumjev, Fiasp)
FCL requires fast insulin. This is so that at the start of meal-related BG rise, FCL is able to keep BG in range (by common definition, under 180 mg/dl (10 mmol/l)).
Моделирующее исследование (подробности см по ссылке Full Loop V2/Март 2023; там же раздел 2.2) показывает, что инсулины короткого действия
Источник:
EEE Control Systems Magazine, ResearchGate The Artificial Pancreas and Meal Control: An Overview of Postprandial Glucose Regulation in Type 1 Diabetes;
will result in significantly lower BG* peaks than slower insulins;
tolerate a couple of minutes delayed first meal bolus while not incurring unacceptable height of peaks; and
minimise the effect on BG peak from different carb loads (meal sizes).
FCL is unlikely to be effective with insulin other than Lyumjev or Fiasp, unless the user is on a very moderate to low carb diet.
However, Fiasp or Lyumjev can result in frequent pump occlusions, even after optimising things like needle length. It is important to have an eye on the cannula or pod time. Many users find 48 hours to be the efficacy insulin limit before resulting in cannula/pod failure.
Prerequisites
BG values and stable bluetooth connectivity are required to ensure AAPS can optimally perform without losing valuable time. FCL requires a 24/7 technically stable system:
your **CGM’s performance. Your CGM should not produce jumpy BG values that could be misinterpreted by FCL as a sign of a starting meal. Similarly, CGM calibrations can produce jumpy results.
how and where any CGM smoothing is done, and what this might imply for your tuning. Notably how delta is defined, and AAPS recognising this as being sign of a starting meal.
bluetooth stability for the pump and CGM pump;
avoiding (or at least early recognition of) pump occlusion;
data flow and your phone’s apps used and difference between days of sensor usage;
keeping all AAPS components well charged and in spare parts close proximity; and
actioning cannula (or pod) changes always early enough to lower the risk of occlusion;
The above will vary depending on your AAPS component system and your lifestyle.
Ограничения, относящиеся к приему пищи
Setting up a FCL may be easier for people whose diets do not consist of food components with a rapid high effect on BG, and meal patterns that do not wildly vary day-to-day. This does not necessarily mean low carb.
Fat or protein rich diets, or slow digestion/gastroparesis, make things easier rather than harder for FCL because late carbs nicely cover for inevitable “tails” of late action from bolus needed around peak time.
Glycemic index and effect on blood glucose
The challenge for the UAM mode rises with rising „Effect on Blood Glucose („EBG“)
Start moderate/low, and tune your Profile’s settings. Only then, «test» meals with high EBG.
Consider a < 50% initial bolus if consuming very high EBG.
No EBG: e.g. fresh meat, fish, eggs, bacon, oils, cheese. 2) Low EBG: e.g. fresh vegetables and berries, mushrooms, nuts, milk, yoghurt, cottage cheese. 3) Moderate EBG: e.g. whole grain bread/noodles, potatoes, wild rice, oats, dried fruits. 4) High EBG:e.g. wheat breads, baguette, toast, waffles, cookies, mash potatoes, noodles, rice. 5) Very High EBG: e.g. sugar, sweet drinks, fruit juices, cornflakes, candy, sweets, potato chips, salty pretzel sticks.
The most difficult meals for FCL are those foods exclusively very high and high EBG components (see red in the picture): Not only does BG shoot up rapidly, but also there is little fat/protein/fibre component to balance the inevitable “tail” of insulin activity that would come with attempts to control the high glucose earlier on.
Erratic consumption of snacks and sweet drinks that are loaded with fast absorbing carbs is problematic for FCL.
Подготовка к физическим нагрузкам
When exercising or being active, with a pump or hybrid closed loop it is recommended that the user reduces IOB prior to exercise.
With FCL, the algorithm is tuned to detect UAM and automatically deliver insulin to counter BG rises. A high Temp Target and lower Profile Percentage (effective already around meal start) should be set well in advance of any activity.
Unusual or erratic exercise activity levels present difficulties for FCL. Planning ahead is required for exercise (especially if you want to reduce the need for rescue carbs/snacks during sports low). After an active day it is recommended that a lower Percentage Profile is set for overnight after the evening meal is fully digested: set in Automations an elevated (>100 mg/dl) BG target, with “no SMBs at elevated target” selected in AAPS* preferences.
Сложности для детей
FCL can present extra challenges for children and these include:
Lyumjev or Fiasp may not available or well tolerated.
Hourly basal rate may very low, providing a poor basis for big SMBs.
Diet may be rich in sweet components. With the typical low blood volume of a small body, strong tendency towards very high BG spikes.
Growth hormones and going through marked changes of insulin sensitivity makes it difficult to keep the FCL accurately tuned.
Enabling boosted SMBs: safety
In HCL safety restrictions are implemented regarding bolus sizes that can be automatically given by the loop.
FCL loopers no longer need to give a sizable bolus around meal start. The impact of this means that restrictions in size limits for SMBs must be widened to make the loop capable of delivering large enough SMBs.
If you are operating with AAPS in the Master release, it is suggested AAPS“ Preferences are set up with the maximum allowed SMB size so that FCL can give (maxUAMSMBBasalMinutes=120, i.e. 2 hours worth of basal at that daytime).
If your basal rate is very low, the resulting SMB limits might be too low to allow sufficient control to tackle postprandial BG rises. One possible solution is to avoid diets that cause strong BG spikes and later switches to a AAPS dev variant that offers a new parameter in SMB delivery settings: smb_max_range_extension. This will expand the standard maximum of 2 hours worth of basal by a factor of >1. (Additionally, the default 50% SMB delivery ratio might be elevated in dev. variants).
Follow the instructions to enable AAPS to mimic your bolussing via a couple of SMBs.
Check the SMB tab periodicallu to see whether your SMBs are allowed to be sufficient enough to deliver the required insulin needed for the loop around meal starts.
Иначе, все усилия по настройке параметров не приведут ни к чему!
Boosting ISF can become dangerous
Carefully observe/analyse the SMB sizes shortly after your meal commences. Настраивайте пошагово и никогда не меняйте более 1 или 2 параметров одновременно.
Your AAPS“ setting must be sufficiently set up to cope with your (!) variety of meals.
Обнаружение приёма пищи/ Автоматизация для повышения эффективности
For successful FCL, ISF is the key tuning parameter. When utilising AAPS Master + Automations, a > 100% profile change must automatically be triggered upon meal recognition (via glucose deltas), and provide the sharpened ISF.
AAPS Master allows up to 130% temporary Profile in HCL p mode. Boosting the ISF is done in 3 steps:
Step 1 - review the ISF applicable for this meal time hour within the Profile, and see whether e.g. Autosens suggest a modification that takes care of the current (last few hours’) insulin sensitivity status of the body..
Step 2 - apply a factor (1/Profile%, as set in Automation) to boost ISF.
Step 3 - check that the suggested ISF falls within set safety limits.
FCL’s Automation templates
Boxes to tick at the top. You have the option:
In your Automation list, you can tick the check-mark (to the left of each field) OFF => This de-activates that Automation. For instance you can do this for all breakfast related FCL Automations to go to HCL for breakfast(s).
For each Automation rule you can tick the box for User action => then the defined Actions will not automatically be executed when Conditions apply. Rather, the AAPS main screen will alert you whenever your FCL would automatically give a SMB. You have the opportunity then to say ‘yes’ or ‘no’. This is extremely useful in your tuning phase.
This feature can be useful for certain situations like “foot to floor” syndrome whher there is a sudden rise in BG when getting up in the morning, but the user wants to prevent a fully automatic “breakfast started” response.
The section below provides guidance how to bundle Automation’s Conditions and how to tackle situations in which the AAPS should increase (or decrease) insulin delivery. As ISF cannot directly be tuned, raising Profile Percentage over 100% will do the same for our purposes.
Автоматизированные большие СМБ при росте ГК
The key to successful FCL at the beginning of BG increases from meals, very large automatic SMBS must be given by the loop as quickly as possible “to catch up” with the required IOB needed (compare with your typical administered bolus for similar meal in hHCL!)
To achieve this, data from your HCL should be analysed to determine which deltas might be not meal –related and those delta which might be.
As you can define the Automation within a pre-defined time-window, you need only to analyse there.
If you do very different kinds of meals (e.g. a rather high carb breakfast, but low carb lunch) you can choose to do two different (sets of) Automations for each of the time slots.
Если в ночное время у вас случаются скачки ГК из-за сдавливания сенсора во сне, исключите ночное время из настроек автоматизации
Обычно достаточно пользоваться изменениями / дельтой последних 5 минут.
Но можете использовать одно из усредненных изменений /приращений. By comparing the deltas in the conditions of your Automations you could even define actions of different aggressiveness depending on whether the BG rises in an accelerated way or not.
( delta – short avg delta )>n is a term that could be used for acceleration detection , to trigger first SMB at earliest sign of rising BG. -
Caution: not possible to use with poor or highly smoothened **CGM-values!
A CGM with patchy data puts the user in a bad spot because, to be on the safe side, you need to „sandbag“ your definition which delta is surely a sign of a started meal. This means:
FCL loses additional time, resulting in higher BG peaks and lower %TIR;
you cannot use an earlier or smaller delta which could trigger, also without a meal, the SMBs that are supposed to make up for a user bolus in FCL.
Кроме того, первые подъемы после еды характеризуются низким уровнем активного инсулина IOB. С учетом этого, Автоматизация(#1) для ужина может выглядеть следующим образом:
Автоматизация #1
If Conditions apply, AAPS would give 1 or 2 SMBs in the next 12 minutes, using a boosted ISF according to the set elevated Profile Percentage (in the example, a 30% boost of insulinReq). As long as these Conditions apply, the Automation rule extends by another 12 minutes. A low carb meal might have slower BG rise characteristics. Для такой пищи полезна еще одна Автоматизация (#2), которая срабатывает при более низкой дельте и дает более слабую подачу инсулина.
The same Automation probably will kick in also in higher carb meals, once the steep rise as defined in Automation#1 is over.
You need to “stage” these two (+ maybe a third) Automations to fit with what you see in your meal (variety) => Setting appropriate jump sizes, iob criteria, and amplifications will be an iterative tuning process. Кроме того, если в Условия добавить соответствующие временные интервалы, вы сможете легко создавать различные автоматизации для разных приемов пищи (завтрак, обед, ужин).
Note that, still in the rise phase (!), the «overflow» of iob must be blocked so that the late effects of the insulin (the «tail» after 3-5 hours) will not exceed the braking capacity of the loop through zero-temping (“taking away” basal, to reduce hypo risk).
При большом приёме пищи иногда наблюдается вторичное увеличение уровня глюкозы. К этому времени, обычно, уровень активного инсулина немного падает, и более агрессивная Автоматизация снова вступает в силу. (Убедитесь, что критерий активного инсулина в Автоматизации #2 не слишком низок, чтобы это смогло произойти).
Soon after a few initial SMBs are given comes a balanced phase where moderate delivery of insulin should cover the additional carbs absorbed. (Except in low carb meals, where the loop might see too weak of aBG rise, and go into zero-temping right away already now).
The AAPS main screen (where you see cob=0 in UAM full loop) might in this phase ask for more carbs required. In UAM mode that simply means, you could make a very rough plausibility check: Is that amount of carbs likely in your body, un-absorbed from your meal just about an hour ago (about which you gave your loop no info)?
порог активного инсулина IOB
Often, Automations #1 and/or #2 make iob rise to heights that typically are enough for your meals. For personalised tuning, look in your HCL data at the max iob values that occur with well-managed meals (often: your meal bolus), and above which magnitude a hypo (or requirement for extra carbs) occurred at the end.
Разумные ограничения активного инсулина IOB, при которых следует снизить агрессивность цикла, могут не совпадать для разных видов пищи. But especially in the first hour after the start of a meal, which is very crucial in the UAM mode. It will defer to for each user. For some users just about 30g/hour get absorbed, and to define a meaningful iob independent of the exact meal can be possible.
For exceptional meals, or to lower it if sports follow, the iob threshold can rapidly be set differently in your Automation.
Automation(#3),”iobTH reached => SMBs off”, is defined to end (or pause, until another wave of carb-related rise hits) the aggressive SMB boosting.
Автоматизация #3
It tells the loop that above your set iob threshold it’s better not to use any more SMBs
The given example does that by setting TT=111 (which is kind of arbitrary; pick a number>100 that you easy recognise as your automated SMB shut-off)
In AAPS“ Preferences/ SMB Settings generally do not allow SMB at elevated target).
The insulin required will then have to be delivered with much more caution through the bottleneck of TBRs
Внимание: Автоматизация #3 работает только при отсутствии временной цели TT. Поэтому, если ранее устанавливалась «Временная цель TT Ожидаемый прием пищи», она должна быть завершена к этому времени, обычно спустя 30-40 минут после начала еды.
One way to do this is to set up an Automation Condition that ends an eventually running EatingSoonTT under the Condition iob>65% * iobTH.
Ways to work with EatingSoonTT Some loopers set (by pressing the TT button, or automated via a lowered Profile BG target if eating time slots are fairly fixed) an EatingSoonTT roughly an hour or more before meal start, just to guarantee a low starting BG and slightly increased iob. But, assuming the FCL is always en route towards target, this might not yield much and you may prefere to define an Automation that sets an EatingSoonTT at recognition of meal start (glucose delta, or acceleration = delta > avg delta). A low TT is important in this stage because any SMB is calculated by your loop using (predicted glucose minus TT)/sens, so a small TT makes the resulting insulinReq bigger.
After the first boosted SMBs were given, your set iobTH and Automation* #3 should strike a good balance of limiting the glucose peak, but also not leading to a hypo after the meal.
If your breakfast substantially deviates in carb content from your average dinner, you may benefit from defining Automations that apply in the respective times of day, and have different iobTH (possibly also different deltas, and different Percentage Profile set). Both, you with defining your meal spectrum and settings (notably, iobTH), and the loop managing the unfolding BG curve, must accept certain peak heights for reducing hypo danger towards the end of the DIAs from SMBs.
Застой на высоких значениях ГК
In case, after a “rich” meal, a long-lasting stagnation with high BG value is seen, Automation #6 (below, left),»post-meal High”, helps deal with fatty acid resistance: After multi-course meals, large greasy pizza, raclette evening, the glucose curve can form two humps or, very often, an elongated high plateau.
Автоматизация #4
Автоматизация #5
Автоматизация #4, «Высокая ГК после еды», подходит и для гибридного цикла.
Кроме того, Автоматизация #5, “Stop post-meal High”, применяется для снижения агрессивности подачи инсулина как только начинает падать уровень глюкозы. (Однако часто алгоритм всё равно ограничивает количество инсулина для предотвращения гипогликемии, поскольку прогнозируемый уровень глюкозы уже снижается).
Предотвращение гипогликемии
The core problem is that the UAM FCL (without carb inputs) can have no idea how many g of carbs are still available for absorption, and might use up that “tail” insulin, without you going into a hypo from it.
Using boosted SMBs, the FCL “caught up” with what we formerly did with a meal bolus. Но в конце периода активности инсулина, на первое место выходит профилактика гипогликемии.
In preparation for FCL, the user must take a closer look at the time course of iob for typical meals, and judge when it becomes too much, and how you can catch that by tuning your Automations. That is possible because we have several adjusting screws. It can be a challenge to get this right
Как правило, не имеет смысла оптимизировать настройки для одного вида питания. Как только появятся хорошие настройки для любимого обеда, следует проверить, как они работают с другими продуктами, а где потребуются «компромиссы».
Чтобы предотвратить гипогликемию в послеобеденные 3 – 5 часов, уменьшите агрессивность алгоритма и не допускайте избытка активного инсулина. Конкретные способы:
Become milder and milder with the ISF already during the glucose rise, as in Automation examples #1 and #2 given.
Define the iob threshold, from which AAPS is made significantly more cautious (Automation #3, above). Note this iob can be exceeded, by the last SMB before it went into effect; and then further by TBRs if the loop sees insulinReq Carbs getting absorbed will provide a counter-movement towards lower iob.
The iob threshold could be differentiated according to meals: By cloning the automations, you could easily differentiate for breakfast, lunch, and dinner time slots (or even for geo-locations, like company cafeteria, or at mother-in-law etc)
You could differentiate within these time slots even further by setting different TTs for low carb vs. fast carb, etc., and thus be able to “code for” different meal classes that may occur at this time of day, and call them up with Automations specially tuned for them. This is probably not necessary, unless your diet habits do vary a lot.
Before a special meal challenge, you can raise your iob threshold, or make another change in any of your Automations within under 5 seconds, right from your AAPS main screen (burger top left; or Automations tab, depending how you configured your AAPS).
Опасность гипогликемии через несколько часов после еды, по существу, зависит от того, будет ли оставшийся инсулин расходоваться на покрытие «пролонгированных углеводов» (излишних/замедленных углеводов/белков/жиров/клетчатки).
Со временем вы изучите закономерности, настроите свою Автоматизацию – возможно, даже немного скорректируете свои привычки в еде, чтобы, например, просто получать удовольствие от случайного (!) перекуса, который поможет поддерживать хороший баланс между активностью инсулина и усвоением углеводов.
Очерёдность применимости настроек Автоматизаций
Problems can arise with overlapping definitions in Automations. Example: The problem is that delta >8 is also delta >5, i.e. there may be two competing Automations What does the loop do then? It always decides according to the sequence in which your Automations appear when looking into the burger menu / AdAPS main screen. Пример: Правило дельта > +8 должно быть первым в списке (и если все правила активны, запускать самый сильный ответ); потом алгоритм проверяет значение дельты >5 (соответственно более мягкий ответ). Если отсортировать список наоборот, правило дельта>8 никогда не вступит в силу, поскольку правило дельта>5 уже применяется первым.
Tip for Automations: Order changes are very easy to make. Press on a list entry in AAPS/Automations and the user rearrange the Automations in question to another position.
Можно очень быстро подстраиваться к любым условия или действиям, прямо на экране AndroidAPS; например, если вы отправляетесь на праздничный ужин. (Но не забудьте вернуть очерёдность списка в нормальное состояние на следующий день).
Устранение неполадок
Как вернуться к гибридному замкнутому циклу
You can un-click the top boxes in the Automations related to your FCL, and go back to bolusing for meals and make carb inputs again. You may have to go to AAPS Preferences/Overview/Buttons and get your Buttons “Insulin, Calculator…” back for your AAPS main screen. Be aware that now it is again up to you to bolus for meals.
It may be wise to do FCL only for meals (time slots) where Automations are fully defined and clicked on, and un-click only those for the other meal times when you like to do HCL (or have none defined yet, in your transition period).
For instance, it is perfectly possible, without any extra steps after Automations for dinner time slots are defined, to do FCL only for dinners, while breakfast and lunch are done in a HCL as you are used to.
Соблюдены ли все предварительные условия для самодостаточного замкнутого цикла?
Is the basic Profile still correct?
Has the CGM quality deteriorated
Refer to pre-requisites (above).
Уровень глюкозы поднимается слишком высоко
Момент приёма пищи не распознается вовремя
Проверьте стабильность Bluetooth-соединений
Check whether you could set smaller deltas to trigger first SMB
Экспериментируйте с аперитивом, супом за несколько минут до начала еды
Слишком малые дозы микроболюсов SMB
Check order of Automations (e.g.: big delta before small delta)
Check (real-time) in SMB tab whether hourly profile basal and set minutes (max 120) limit allowed SMB size
Check (real-time) inSMB tab whether %profile must be set bigger
Если все настройки достигли лимитов, возможно, вам придется жить с временным высоким или применить диету.
Если вы готовы использовать AAPS версии для разработчиков, вы можете использовать ту, которая позволяет увеличить размер SMB. Некоторые пользователи также прибегают к небольшим преболюсам в своих «самодостаточных системах замкнутого цикла». However, this interferes with how glucose curve and hence detection of rises and triggered SMBs behave, and is therefore not easy to implement with convincing overall benefit.
Важным наблюдением со стороны группы испытуемых было то, какую тенденцию ваши кривые глюкозы и активного инсулина (IOB) имеют к моменту приема пищи, это оказывает существенное влияние на пики от приёма углеводов: Снижение уровня (напр. настройка «Включить временную цель TT Ожидаемый прием пищи») позволяет увеличить содержание активного инсулина IOB и удерживать пики в более низких пределах.
Уровень глюкозы падает слишком низко
Некорректно определяется время начала приёма пищи
Check whether you could set bigger deltas to trigger first SMB
Отметьте галочкой «Действия пользователя» в соответствующей Автоматизации, чтобы в дальнейшем иметь возможность на месте решить, остановить ли выполнение Автоматизации, если приёма пищи на самом деле не было
To prevent snacks from triggering SMBs as for a meal, set a TT>100 when snacking (as you would do in sports and for anti-hypo snacks, anyways)
SMB вводят слишком много инсулина
Check (real-time) in SMB tab whether SMB range extension must be set smaller
Check (real-time) in SMBtab whether Percentage Profile must be set smaller
Коэффициент SMB вероятно должен быть меньше, чем установлен. Note in this case, it works across the board for all SMBs (all time slots),
Проблемы с инсулиновым «хвостом» после еды
Возможно, потребуется перекус (из-за прогноза гипогликемии) или прием таблеток декстрозы (если вы уже в зоне гипогликемии). Но обратите внимание, что углеводы, которые может запрашивать алгоритм, скорее всего, сильно преувеличены, поскольку петля не имеет информации о потреблении углеводов (в то время как вы можете предположить, сколько ещё не было усвоено, включая жиры и белки).
A valuable information would be whether the problem originates mostly in the bg rise phase already. В этом случае поможет установка более низкое порога активного инсулина iobTH.
Если потребность в дополнительных углеводах возникает слишком часто, запишите, сколько граммов потребовалось (не считая того, что вы в итоге переборщили и вам снова потребовался дополнительный инсулин). Then use your profile IC value to estimate how much insulin less the SMB should have delivered, and go with this info into your tuning (regarding the Percentage Profile in Automations, or maybe also your set iobTH). This may relate to theSMBs given when glucose was high, or also extending regarding also the SMBs during the BG rise.
It could well be that you simply have to accept higher BG peaks for not going low. Или поменяйте диету, чтобы в ней было меньше углеводов и больше белка и жиров.
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