This excellent, data-rich summary from our friends and colleagues at Close Concerns.

MEMORANDUM

ADA initiates “Amputation Prevention Alliance” to address sky-high rates of diabetes-related amputations – October 3, 2022

Three-year Alliance powered by the ADA’s #HealthEquityNow platform as well as five companies across the diabetes ecosystem, including Podimetrics and Abbott

The ADA recently announced the formation of an “Amputation Prevention Alliance,” a three-year initiative aimed to address the crisis of preventable diabetes-related amputations in the US – see a video from ADA CEO Mr. Charles Henderson announcing the formation of this initiative on YouTube. The ADA has tapped five partners (Podimetrics, Abbott, Advanced Oxygen Therapy, The Critical Limb Ischemia Global Society, and Cardiovascular Systems) under its #HealthEquityNow platform to band together and drive forward three key objectives: (i) advocating for policy-level changes to advance diabetes-related foot care and prevention; (ii) increasing clinician education around caring for diabetes complications; and (iii) improving patient awareness of warning signs that point to progressively worsening peripheral arterial disease (PAD).

Table of Contents [hide]

• Ambitious and admirable three-year Alliance aims to remediate US amputation crisis through policy-level advocacy and patient-provider education
• A distinguished hexad: ADA taps Abbott, Podimetrics, Advanced Oxygen Therapy, Cardiovascular Systems, and CLI (Critical Limb Ischemia) Global Society
• Health equity is embedded at the core of the Amputation Prevention Alliance, rightfully so
• KOL Commentary
• Close Concerns’ Questions

Ambitious and admirable three-year Alliance aims to remediate US amputation crisis through policy-level advocacy and patient-provider education

According to the ADA’s press announcement, the majority of the 154,000 amputations that occur each year in the US are preventable, but structural barriers that undermine access to quality care mean that many people with diabetes are “forced into unnecessary amputations and even death.” As such, this Alliance will focus on advancing its three pillars to not only remediate the concerningly high prevalence of amputations in the US but to also address the concerning racial disparities in amputation risk among people with diabetes (more on these disparities below).

• A cornerstone of this alliance will be to advocate for policy-level action that could be meaningful in preventing amputations. While this statement may appear to be broad, we view this commitment as particularly important given that amputations are prominent among older adults with diabetes, many of whom are on a government-sponsored healthcare plan (e.g., Medicare or Medicaid). An example of active legislation at this juncture is the Amputation Reduction and Compassion Act of 2021, which was introduced to the House in April 2021 and provides coverage of PAD screening without cost-sharing for “at-risk” Medicaid and Medicare beneficiaries (as well as those on private insurance). As we learned at ACC 2022, the bipartisan bill would also prohibit the use of amputation without completion of arterial testing (i.e., vascular ultrasounds or angiograms) to determine if alternative interventions could be applied. Additionally, the bill would require the development of educational programming and Medicare quality measures to reduce amputations related to PAD. Given all the discussions over the last year (at the Digital Quality Summit and beyond) around quality measures in diabetes related to CGM-derived metrics and behavioral health outcomes, we have come to understand implicitly the importance of quality metrics in ensuring that HCPs are being incentivized to help their patients achieve the best possible outcomes.
• Aside from policy levers, the Alliance will target high-need communities, focusing on “driving clinician awareness of opportunities to prevent amputations,” as well as “empowering patients to advocate for their best care.” Over three years, the Alliance will aim to increase access to quality care, technology, and “necessary interventions.” We’re thrilled to see that Podimetrics is at the fore of this Alliance, given that the company is one of the leading players in preventing amputations. In the ADA’s press announcement, Dr. Jon Bloom (CEO, Podimetrics) said that the company is particularly looking forward to participating in the Alliance because an estimated 85% of all diabetes-related amputations are preventable. The Alliance’s focus on health equity is undoubtedly admirable – this project will require meeting many goals within a relatively narrow frame of just three years – we love how ambitious this is. That said, we’re curious to understand more specifics around what clinician education and patient awareness initiatives would look like when brought to fruition – there is so much that can happen. At times like this, we particularly miss advocates like the late Mr. Thom Scher. We hope that many respected patient education organizations like Beyond Type 1, Beyond Type 2, Children with Diabetes, Diabetes Sisters, diaTribe Learn, JDRF, and multiple others will be spread the word on this like wildfire. With an organized, vocal, self-identifying (for both T1D and T2D) narrative that no one with diabetes globally should ever have to experience amputation – the sky is the limit. How does the field get there? Of course, it is essential that everyone know where they are starting, understand their numbers, and understand what they need. Everyone with diabetes deserves the right focus to get the right medicine and treatments at all the right doses using all the right technology – that’s easier said that done. Still, it’s a no-brainer that ADA, Podimetrics, and Abbott will be able to work intelligently on this together and bring in all the patient organizations. It will be key to make sure that organizations work together on ways to get the education right.  Advanced Oxygen Therapy, The Critical Limb Ischemia Global Society, and Cardiovascular Systems are all new entities to us and we hope very much that messaging is a major component of this. In the meantime, we also hope that the patient organizations look to work together on this – what a head start ADA is providing. We look forward to seeing a toolbook!

A distinguished hexad: ADA taps Abbott, Podimetrics, Advanced Oxygen Therapy, Cardiovascular Systems, and CLI (Critical Limb Ischemia) Global Society

Alongside the ADA, five companies have come together to form the Alliance, each bringing a unique vantage point. We appreciate the range of perspectives converging to tackle this complex crisis that is in desperate need of intervention. Below, we give a synopsis of the five organizations joining the Alliance – as noted, some are more familiar to us than others, so we also include relevant background information for players who might not be as well-known.

• Abbott: We’re thrilled to see one of the largest industry partners in our field join the Amputation Prevention Alliance. YES! The Alliance can no doubt benefit from the brainpower of Abbott’s commercial teams who are seasoned medical device innovators, and also from Abbott’s vast network that spans edge-to-edge within the diabetes galaxy. We can’t wait to see all the ways in which Abbott will help propel action on using CGM as a preventative tool to detect PAD, and to partner with other players who rely on remote patient monitoring (e.g., Podimetrics) to think about how glucose monitoring and foot monitoring could deployed together to improve patient outcomes – lots to consider and to do! What would patients most like to see here? We can’t wait to hear that too and will be asking dQ&A what it would advise.
• Podimetrics: Fresh off a $45 million Series C in March (what fortunate timing), Podimetrics will join the Alliance with a wealth of knowledge to offer. As background, Podimetrics’ SmartMat is an at-home telemedicine system for diabetic foot ulcer (DFU) prevention, designed to remotely monitor and analyze temperature asymmetries in patients’ lower extremities by scanning each foot for 20 seconds. Each device has 2,000 temperature sensors that create a summative thermogram of the foot, which can be gedsaved, processed, and sent for analysis by a remote care team who have specific protocols designed for intervention and clinical escalation if needed. We see so much upside from Podimetrics’ participation, especially given that the company has published a landmark analysis characterizing the scope of the amputation crisis. Thank goodness this company exists and has emerged, ready for action.
• Advanced Oxygen Therapy: Oceanside, California-based Advanced Oxygen Therapy has developed a topical wound oxygen (TWO2) therapy using pressurized oxygen that can be directly applied to foot wounds to promote healing. This type of therapy is similar in concept to PVRmed’s device that we saw at ATTD 2022 that stimulates neo-angiogenesis on feet through noninvasive carbon dioxide application. Of course, while some would say they’d much rather see prevention rather than action of this sort, this is absolutely essential to have given the state of diabetes care.
• Cardiovascular Systems, Inc. (CSI): Saint Paul, MN-based CSI is a medtech company with a range of peripheral and coronary artery solutions that promote revascularization. It’s great to see that the Alliance can benefit from companies making tech that operates more upstream in terms of preventing PAD (e.g., Podimetrics’ SmartMat) as well as solutions more downstream in terms of treating PAD (e.g., CSI’s revascularization devices). Of course, the goal is for all these solutions to be employed upstream of complications – those being amputations in this case.
• The Critical Limb Ischemia (CLI) Global Society: The CLI Society is a mission-driven organization aiming to improve quality of life by preventing amputations and death due to critical limb ischemia, which is an advanced form of PAD affecting blood flow in the lower extremities. Presumably, the CLI Society’s participation ensures that a range of academic and clinical perspectives can lend their expertise to the Alliance as it forges on an ambitious journey of reducing preventable amputations in the US.

Health equity is embedded at the core of the Amputation Prevention Alliance, rightfully so

Importantly, the ADA’s press announcement specifies that diabetes-related amputations affect communities of color at an alarming rate – says the press announcement:

• Black Americans face rates of amputations up to four times higher than non-Hispanic white Americans;
• Latinx communities are 50 percent more likely to have an amputation than non-Hispanic white Americans; and
• Indigenous communities face amputations rates that are two times higher than those among non-Hispanic white Americans.

Given the documented dramatic racial disparities across diabetes-related amputation rates, we are very heartened to see that the Alliance will pay attention to these healthcare disparities and focus on intervening in high-need communities. See some graphics taken from the Amputation Prevention Alliance’s website below.

KOL Commentary

• Dr. David Armstrong (USC Keck School of Medicine): “I could not be more excited about the development of limb preservation – almost as its own specialty now. I see a real shift – and I’ll give you an example: just this last week, we had our DFcon meeting, which is in its 22nd year. I started it with George Andros way back when. To see now, in the audience, young men and women, many with NIH career development awards, some just starting practices, others starting academic careers, meeting up, going out to dinner in completely different specialties (vascular surgery, podiatric surgery, diabetology, infectious disease, engineering, etc.) and then forming collaborations and teams – it’s so heartening, especially to see patients at the center of all of this. Patients were at the center of our discussions at DFcon, and some even attended the meeting. Now, you have this Amputation Prevention Alliance by the ADA, which I think is just a spectacular way forward. To see ADA taking a leadership role here is another signal that things are moving ahead. To see all this happening now is really life-77affirming.”
• Dr. Bob Gabbay (Chief Medical and Scientific Officer, ADA): “There are 154,000 diabetes-related amputations that occur every year in the United States, meaning that, every three minutes, a person with diabetes is losing all or part of a limb. Many of these – as many as 85 percent – procedures are preventable. What’s worse – five-year mortality numbers after amputations are worse than many forms of cancer. The ADA is proud to have launched our Amputation Prevention Alliance, which is a first-of-its-kind collaboration designed to prevent amputations and save lives through targeted policy action.”
• Dr. Donna Ryan (Pennington Biomedical Research Center): “When I talk to newly diagnosed patients with type 2 diabetes or even with pre-diabetes, they frequently remark on the legacy of their family history. They will talk about a parent or grandparent who had diabetes and frequently bring up amputation. They say, “I don’t want that to be me. What can I do to prevent the complications of diabetes?” Family members of individuals with diabetes who have had amputation of a limb know well the impact this has on quality of life for the individual and his or her loved ones. Amputations, usually for a chronic infection secondary to peripheral neuropathy and trauma, are preventable.  I am delighted to hear about ADA’s Amputation Prevention Alliance. We all need to recognize that preventing amputation begins with access to high quality diabetes care, from the very first visit.”
• Dr. Foluso Fakorede (Cardiovascular Solutions of Central Mississippi): “I am proud to be part of the APA working group. A campaign to achieve health equity for underserved communities with diabetes by preventing unnecessary amputations – a death sentence for majority of these patients who suffer in pain and silence from this virulent practice. Every three minutes in the US, a limb is amputated due to diabetes and it has a clinical, economical, and human impact.  The ADA has launched an Amputation Prevention Alliance to drive policy changes, collaborate with stakeholders, policy makers and leading health advocacy organizations to improving overall health outcomes for people with diabetes with equitable policies and recommended practices. Given the link between diabetes and amputations, the ADA is well-positioned to lead a collective advocacy effort.”

Close Concerns’ Questions

1. The Alliance sounds like a fantastic, action-oriented coalition. What are the biggest milestones that the Alliance will be looking to achieve?
2. What achievements will constitute success in the eyes of all Alliance participants? Presumably, lower amputation rates of any sort will be deemed a “win” by all players involved – what will the Alliance perceive of as a major win?
3. How might progress on “less serious” amputations be acknowledged – i.e., how does the field talk about limb amputations involving “below the knee,” “toe only,” etc?
4. How can more patient views be included? We learned enormously in Blood Sugar Rising, for example, from Monteil Lee – and without having watched this incredible portrait of this patient, we would understand far less about amputations and diabetes. Is it possible to expand such learning and connect it to prevention?   
5. What motivated the “time-boxing” of this Alliance to just three years? We are so heartened to see the action that the Alliance is looking for.
6. In the words of the leaders, there is one metric – number of amputations. What does it take to get metrics on this front that are more up-to-the-minute? Has a dashboard been considered? What does that take? How is accuracy overall with this arena?
7. Are there any unintended outcomes to avoid? For example, when amputation is better for patients, such as toes, will there be any unintended pressures to avoid this? Have any regression models been considered to assess progress in the field?
8. As is the case with many partnerships in the field (write us here to learn more about the 350+ partnerships in our database), the beginning of a partnership is often more “publicity-worthy” than the end. As such, when can we expect to hear updates from the Alliance to ensure the spreading of success related to progress? Undoubtedly, we imagine the Alliance will have a presence at scientific gatherings (e.g., ADA 2023 in San Diego) to report ongoing and future projects – how can the rest of the diabetes ecosystem support this?

–by Armaan Nallicheri and Kelly Close