10. HCPs and APS
It is hard to define what HCPs need to know about APS, because they need to know what patients know about APS, too. So if you are a HCP reading this chapter, I hope you’ll also take a look at the rest of the book, too. APS has tremendous benefits for patients, ranging from achieving improved clinical outcomes to reducing the burden of managing diabetes and improving quality of life. APS also has benefits for providers, too. It may take away some of the difficulty of helping patients achieve their ideal outcomes, and make the remaining work easier and allow you to focus more on the more fulfilling task of helping your patients make fully informed tradeoffs in their particular situation. But I also recognize that most HCPs have not yet been trained with APS – it still isn’t something that is taught in medical school. We are learning together as we go – the early adopters and HCPs – to figure out how best to use APS in real life and clinical care.
It may seem scary for HCPs, especially when patients are leading the way with this new technology. But it’s helpful to remember that patient innovation is not new. The patient community leading the way demanding increasing access to new technology is not new. This is even more true in the diabetes field. Do you remember hearing about the advent of at-home blood glucose testing, back in the 1970s? Patients led the way, demanding the ability to test their BG at home. At the time, clinicians were very concerned about patients’ decision making abilities and the ability to handle the additional information it provided them.
Does that sound familiar? The same arguments were made about continuous glucose monitoring, and whether patients should be “blinded” (prevent from seeing in real-time) their own data. The same arguments were made about dosing insulin from CGM. The same arguments still appear today around flash glucose monitoring. The same arguments happened when insulin pumps were invented.
It’s no surprise therefore that the same concerns are now front and center with regards to artificial pancreas technology and related systems.
"Dear optimist, pessimist, and realist:While you were arguing about artificial pancreas technologies... we’ve been using it. For years.Sincerely, The do-it-yourself diabetes community”
Healthcare technology is well-known for being behind technology in other sectors. And do you know what unfortunately lags further behind that? Policy, education, and tools to help healthcare providers (HCPs) understand how to use, support, and otherwise deal with the technology. You should expect that many HCPs will be unfamiliar or uncomfortable with most APS technology - DIY or commercial - for many years to come. Fortunately, there are outliers! Some HCPs use APS themselves, have been trained on it, are adopting & encouraging adoption and promoting access. Some HCPs are reaching out to learn more from non-traditional resources like this book. But the average experience will be more likely that patients will have to ask for APS, or a different kind of APS than the sole option that might be recommended, and likely end up educating their HCP about other options along the way.
I know that this might sound pessimistic. It’s not to scare you off, or offend any HCP who reads this. But, both for DIY or commercial APS, and similar to patients having to ask (and demand) for access to CGM, it’s going to take a lot of effort from patients and the community to get to the point where it becomes the new standard of care. I think the patient community therefore have an ongoing, important role to play that doesn’t end when more commercial APS are approved to the market. “Approved” doesn’t mean accessible, let alone affordable, for patients. And HCPs’ attitudes towards this technology are also going to play a role - but hopefully one of increasing access rather than adding additional barriers.
Thankfully, diabetes organizations are stepping up and beginning to release position statements to encourage and emphasize that patients have the right to choose their technology. Diabetes Australia released the first position statement in late 2018, emphasizing patient choice. JDRF UK followed in February 2019 with a similar position statement, and many others are in the works as well. While there are still cultural questions that remain about liability for physicians, there is a growing awareness and acceptance that patient choice is paramount. As it should be.
We still need HCPs. Point blank. APS won’t take that way, and it doesn’t risk the job of HCPs. In fact, we know there’s a shortage of trained endocrinologists and other diabetes- related care providers. If you’re a HCP, APS will change the way you work, and what you have to do - but I see this as a good thing. HCPs will be able to work “to the top of your license” and take care of the hardest problems that technology has not yet addressed.
However, companies will need to do a better job with what tools and reports they provide - for both patients, and providers. We need to design carefully the data that is provided to us patients in real-time, as well as for retrospective review. The same goes for HCP reports and the ability to analyze data retrospectively to help spot bigger picture trends and problems that they may spot. Right now, I think HCPs have a hard job to do without these reports and tools. APS should theoretically also reduce the burden on the healthcare team - but hasn’t yet. We need it to get there and reduce the cognitive burden on HCPs to match the reduction on workload and cognitive burden that it provides to patients.
Sometimes, I see HCPs hear about APS and have a knee- jerk reaction that it must be risky. When they have that reaction, it seems like they forget how risky manual diabetes is for everyone on insulin-dependent diabetes. And the same thing for whether a technology or type of APS is regulated or not. Yes, a regulated or “approved” version of technology means it has been vetted by a regulatory body and approved for general use. But that doesn’t mean it’s perfect. Again, it’s not a cure for type 1 diabetes. It still requires some work on behalf of the person living with it and to figure out how to make it work for them.
I wish HCPs who work with patients with diabetes knew the following:
When a patient chooses to use a particular technology, it’s for a good reason. And, it’s worth finding out why a patient has made this choice. Especially in the case of a DIY APS. Yes, DIY tech is off-label. But that’s ok – it just means it’s off label: it doesn’t prevent you from listening to why patients are using it and what we think it’s doing for us, and it doesn’t prevent you from asking questions, learning more, or still advising patients 1:1 about their choices. There is a growing body of position statements to back you up in supporting your patients.
Patients dread talking to HCPs about their choices, because they’re afraid. They’re afraid you’ll refuse to listen to us, to discuss it, or that you’ll fire us as patients. Please don’t make us switch providers by refusing to discuss it or listen to it, just because it’s new/different/you don’t understand it. (By the way: we don’t expect you to understand all possible technology! You can’t be experts on everything, but that doesn’t mean shunning what you don’t know.)
You get to take advantage of the opportunity when someone brings something new into the office – it’s probably the first of many times you’ll see it, and the first patient is often on the bleeding edge and deeply engaged and understands what they’re using, and open to sharing what they’ve learned to help you, so you can also help other patients!
You also get to take advantage of the DIY community. It’s open, not just for patients to use, but for companies, and for CDEs and other HCPs as well. There are dozens if not hundreds of active people on Twitter, Facebook, blogs, forums, and more who are happy to answer questions and help give perspective and insight into why/how/what things are. In many cases, we’re begging HCPs to be involved and connect with the community.
Don’t forget – many of the DIY tools provide data and insight that currently don’t exist in any traditional and/or commercially and/or FDA-approved tool. Take autotune for example – there’s no FDA-approved tool to help patientstune basal rates, ISF, and carb ratio for people with pumps. And the ability of tools like Nightscout reports to show data from a patient’s disparate devices is also incredibly helpful for healthcare providers and educators to use to help patients. These tools for the most part don’t exist as regulated tools or software. They may need to be reviewed carefully, and taken with a grain of salt, but that doesn’t mean they should be categorically ignored and rejected.
When asked for advice they would give to fellow HCP’s, one HCP emphasized to me that there is likely a network of HCPs supporting this already in your area. And if there’s not one, create one! It allows HCPs to learn from one another (in addition to learning from patients). If you can’t find any HCPs in your area, look online to the active community of HCPs. Many happen to have type 1 diabetes and are using this technology personally as well as have patients who have chosen to use it.
In summary, for HCPs:
- Please support your patients & their choices.
- Embrace DIY as a learning opportunity for you.
- Connect with the DIY community for help.
- There are a lot of new, exciting tools for you and patients!
APS is a new model of doing things in type 1 diabetes. That also means we need to develop new models of evaluating things. Some of the methods developed for “evaluating” patient settings decades ago no longer match these older models. For example, some HCPs strongly believe that there should be a specific, fixed ratio of insulin delivered as basal vs bolus on a daily basis. However, there are a few flaws in this methodology.
Say you think there should be a 50% split between basal and bolus insulin. That means someone should get about 20 units of basal insulin, and 20 units of bolus insulin, if their average total daily dosage (TDD) is 40U. However, that is a simplified rule that conflates three different variables. The body needs a certain amount of insulin throughout the day: that’s basal insulin. If the blood sugar is elevated for some reason (leaving out food for a minute), such as stress, exercise, sickness, hormones, etc. - then it needs to be corrected with the “correction factor” or insulin sensitivity factor (ISF). Finally, the third ratio is for food: carbohydrate or “carb” ratio, for how much one unit of insulin will cover how many grams of carbohydrates. If someone eats more carbohydrates one day, they will need more insulin... and you shouldn’t decrease the body’s baseline insulin needs (e.g. basal) to balance that ratio. The ratio therefore gets distorted.
Trying to force the ratio even from the beginning of putting someone on an insulin pump ends up causing a lot of issues for people with diabetes and their eating habits. They may try to contort what and how they eat in order to match their insulin to the “ratio”, rather than what their body actually needs (as baseline and for the food consumed). There is a growing body of evidence around eating disorders related to, and caused by, living with type 1 diabetes. Having a wrong, forced ratio applied to “how much insulin we should be taking” can cause irreparable damage mentally and physically. Plain and simple,
it’s wrong. Your body needs how much insulin it needs. You also need to take enough insulin for what you eat. What a “healthy” diet for the individual is, is another topic of discussion. But for the most part, “how much insulin” should not be determining the diet. That’s backwards.
Then when someone goes on APS, it’s common that the HCP who believes in a fixed ratio (such as 50:50) still demands the same output of basal and bolus amounts. But that doesn’t make sense, even if you believe the ratio works for manual pumping. The artificial pancreas or automated insulin delivery system is designed to dose insulin in response and in prediction of out of range BGs. It doesn’t matter if it’s called bolus or basal. It’s insulin delivered in response to the BGs. Discussing the ratio of basal to bolus also doesn’t work depending on the APS, which might “borrow” from basal in order to “bolus” (or “microbolus”) more up front, achieving flatter BG levels. Each APS works a little differently, and defines insulin delivery in different terms. But focusing on the ratio of basal vs. bolus insulin delivery is a distraction from analyzing the outcomes of what someone is achieving: we should instead be looking at BG variability or post-meal excursions, and properly reviewing and adjusting the factors that influence those outcomes.
And one final point specific to APS and measurement: this technology is going to solve a lot of problems and frustrations for patients and improve outcomes. But, it may mean that patients will shift the prioritization of other quality of life factors like ease of use over older, traditionally learned diabetes behaviors. This means things like precise carb counting may go by the wayside in favor of general meal size estimations, because with the new technology both yield similar outcomes. Being aware of this will be important for when HCPs are working with patients: knowing what the patterns of behaviors are and knowing where a patient has shifted their choices will be helpful for identifying what behaviors can be adapted to yield different outcomes. Behaviors, like settings, are something that can be tweaked to adjust the outcomes of living with APS.
If you are interested in APS, make sure to ask your HCP about it, even if they don’t bring it up. Some HCPs won’t bring it up unless they feel that their patients are “savvy” enough (whether that’s tech savvy, or APS savvy, or some mystical other type of savvy is unclear) to warrant mentioning it. But you don’t have to be “savvy” or already educated. If you’re interested in the idea of APS, it’s absolutely worth discussing with your healthcare team. This pattern of what and when HCPs choose to bring up APS as an option may mirror some of the concerns HCPs originally had around pump adoption and use (and even blood glucose meters themselves, back in the day).
Depending on where you live in the world, you may be able to access and acquire (or build) your own APS, without much input required from your HCP. In other places, you may need a prescription signed off on by your endocrinologist for the full APS, or components of your APS (such as particular pump supplies and sensors that work with your system of choice).
And in any case, you’ll need to decide when and how you talk to your HCP about APS, if you do it on your own. There are a few approaches people take:
Build their own APS, run it for a while, then bring it up in the next appointment when they have data and results to share from it. Usually, HCPs can see the evidence of what’s working well, and say that even if they can’t endorse or recommend it because it’s off-label (and DIY), they can acknowledge that what the person is doing seems to be working well for them.
Bring the choices of APS to the HCP, and discuss the options with the HCP, getting input about the choice and decision of whether or not to use a particular APS. In a few cases, HCPs have been very unhappy with patients doing this, to the point where a patient may end up choosing to switch HCPs (if at all possible) to one that is not so upset about a patient choosing or trying APS. Others, thankfully the majority, will have a reasonable discussion - if they have enough information - about the pros/cons of choosing a system. Others may need to seek or be provided information before they can have such a discussion.
There are some great resources created in the diabetes community. The ones written for patients can often also be great introductory material for HCPs who want to learn more about APS in general, or a particular (especially if it’s DIY) type of APS. There are also often HCP-specific guides written to provide a clinician with information they need to know about the basics and how to support patients going on a particular system. For example, we have created a “Clinician’s Guide to OpenAPS” to have a single link/single page explanation of the system basics, how it works, what the algorithm does, and how HCPs might help patients fine-tune their settings.
For HCPs who are looking for more materials, we’d love to see more from HCPs, by HCPs, for other HCPs! There are several peer-reviewed papers in the literature addressing the HCP audience, but it’s the tip of the iceberg of what’s needed. There’s a lot of room for more studies, more papers, more online guides, and more tools and tutorials to support your fellow HCPs as you figure out how your work will change with APS. (And if I can be of assistance as you create more material, please do reach out. I’m always happy to review, or spread the word about, any new resource!)