Response to the Comment by K. Hood to “Do It Yourself” (DIY)—Automated Insulin Delivery (AID) Systems: Current Status From a German Point of View

We thank our colleague for his comments ¹ to our review on Do It Yourself (DIY) Automated Insulin Delivery (AID) systems from a German point of view. ² His guiding principles for his work with patients with type 1 diabetes are that (a) every person is entitled to life-saving insulin and (b) the person should decide how to administer that insulin.

We fully agree with his opinion that every person with diabetes (PwD) is entitled to insulin. When it comes to the second opinion, we agree that each PwD should decide how to administer the insulin once he or she has sufficient diabetes knowledge by participating in a (recent) training in insulin pump usage. But we were surprised by a number of statements in his comment. For us, diabetes self-management has been beyond doubt since we were—as young scientists in Germany in the early 1980s—most active in establishing intensified insulin therapy (IIT) with appropriate training programs for diabetes teams and persons with diabetes nationwide. IIT was used in our country for a number of years before it became an established therapy in many other countries, including the United States. Empowerment, as it was represented by Bob Anderson and his colleagues in the United States at a later time^3,4, is still the philosophical approach that is accepted without exception among (older) German diabetes teams. And for more than one decade, we have participated in (psychological) studies on systems for AID. ⁵

The cited review, “Do It Yourself” (DIY)-AID Systems: Current Status From a German Point of View,” aimed to review the challenging (medical-)legal situation for members of diabetes teams, who were asked for advice by their patients on DIY-AID systems. Our position is intended to provide maximum safety for PwDs, especially when the safety of uncleared products cannot be known by the patient users:

• - For us, the usage of DIY AID is not an established way to treat each and every PwD. Don’t get us wrong, this also holds true for commercial AID systems. To our understanding, appropriate usage of DIY AID systems requires an in-depth understanding of diabetes; it requires a certain focus on the technology, an experienced diabetes team, and a given amount of handling time each day. If this is provided, such a PwD is qualified to make an informed decision to use DIY AID. The quality of glucose control that such PwDs achieve is truly impressive!

• - However, does this mean that each PwD can use this technology without any risk; is it a “cure”!? At this point in time, the answer to this question is “no” from our point of view. The potential risks and benefits have to be evaluated scientifically, as have been done with CGM-Systems or pumps (still not sufficiently for all aspects though). We wonder how many of the PwDs have quite limited insight into their diabetes therapy as a result of many factors that might drive this, such as being limited in their health literacy, numeracy, access to technology, mental health, or socioeconomic stability. Are you willing to give a DIY-AID system to a PwD who has no good insight into what he or she is doing with it?

• - In a scientific journal like Journal of Diabetes Science and Technology (JDST), there is no room for “marketing” a new approach. There is a need for a critical and careful approach. This does not mean that we aim to block the development of new approaches; we can provide plenty of evidence that we personally actively push ahead many of such developments—also AID systems—however, with the same careful, critical, and scientific approach.

• - One of the reasons for writing the statements about the situation in Germany (and we made this focus very clear) are the challenging legal aspects.

• - What if something happens to the PwD while he or she uses the DIY-AID system—for example, an accident? There is no liability or support for the patient by the manufacturer of the CGM system/insulin pump used. At least in Germany, insurances might argue that this treatment was not prescribed by a physician and can refuse to cover any costs associated with such an event.

• - In the United States, the Food and Drug Administation (FDA) has made clear that uncleared diabetes devices may not be safe to be used by PwDs. This was published by the agency after one death from an uncleared diabetes device, so this is the official regulatory position. If PwDs use non-cleared medical products, are they notified in case there is an upgrade or recall? Who is responsible if the PwD purchases a potentially dangerous device over the internet from an unlicensed distributor?

• - Another factor to consider is if a PwD uses a DIY-AID system and becomes hypoglycemic while driving, then he or she could take out other innocent people in a driving accident; is there not some responsibility to society to not to do anything dangerous that might affect others?

• - The patient’s health insurance might also not cover a problem related to a malfunctioning medical product if patients are using the device in a way it was not intended to be used.

• - So, we don’t argue against principle 2; we want to make clear that risks/traps exist that should be made honestly clear to the PwD and with professional therapeutic distance. As professionals, we have to be aware, that the

empowerment philosophy is based on the premise that human beings have the capacity to make choices and are responsible for the consequences of their choices. It is defined as an educational process designed to help patients develop the knowledge, skills, attitudes, and degree of self-awareness necessary to effectively assume responsibility for their health-related decisions. ³

• - The information given to PwDs must be critically researched, approved, and recommended, before it can ever become a standard of diabetes therapy that is globally used. What is wrong with such an approach? Yes, we vote for a careful approach for each (!) new technology; we have seen issues with, for example, novel drugs in the past several times and also not all routes for insulin application made it toward a standard, for example, inhaled insulin (a field in which LH was quite active and is still a fan of). Would you train a group of patients in using such a technology without having any chance of checking how this works out in daily life? Are you sure that all “side effects” are truly assessed and reported? Would you truly argue that there is sufficient scientific evidence for DIY-AID systems as we speak? Lutz Heinemann is supportive of the OPEN project and is in close communication with a number of prominent members of the DIY AID community. Also, that a scientific journal like JDST publishes a series of articles about these topics in two issues, we believe, speaks for itself. JDST is not a journal for laypeople.

• - Be assured that we are very impressed with the power of the DIY-AID movement and are in favor of this bottom-up approach that is not supported heavily by conventional research structures/manufacturers. You and your colleagues are doing a great job in pushing the development of new algorithms for insulin coverage of meals/exercise/illness, and so forth, forward. The important work done is not of help with DIY-AID systems only, but for diabetes therapy in general; it is taken up by many developers of commercial AID systems.

• - When you argue that physician’s/diabetes teams should support PwDs in using DIY-AID systems, you put them in a difficult legal position. This might be different in the United States; however, we doubt this. In the interconnected society we are living in nowadays, the DIY-AID advocates should also openly inform about this fact.

In summary, we don’t find that DIY-AID systems are currently feasible for the majority of PwDs. We also see the need for an open discussion about the pros and cons of this approach and we’d like to thank you for initiating this (hopefully).

From a professional point of view, we—that is, everybody who is involved in patient care—have to be committed to the care of our patients. We should have a certain therapeutic distance and should avoid transfer and counter transfer. Our review has the aim to highlight risks and legal consequences to the patients whom we are charged to protect, without over-emphasizing them. When PwDs ask us about new therapeutic options like DIY-AID systems, there is a need for information that also refers to critical aspects. Only well-informed PwDs are empowered and can make rational decisions. Yes, different therapeutic pathways exist, but as the therapists, not one way only should be brought forward. ⁶ Usage of DIY-AID systems should not be promoted like a “religion,” but as one option for insulin therapy.