Research updates in health technology, nutrition and diabetes management
Key takeaways:
- Evidence and trust are key to developing digital health therapies.
- “Food is Medicine” initiatives are on the rise.
- Intensive therapy may prevent CVD in diabetes.
PHILADELPHIA — At the Heart in Diabetes CME Conference, speakers highlighted four recent reports published in the Journal of the American College of Cardiology focusing on health technology, diet, diabetic cardiomyopathy and lifestyle.
Neha J. Pagidipati
“We are extremely excited to present the first JACC session in a long time,” Neha J. Pagidipati, MD, MPH, assistant professor of medicine and cardiovascular disease prevention specialist at Duke University School of Medicine and co-chair of the joint session with JACC, said at the start of the presentations.
Read on for this year’s highlights, in no particular order.
Need for evidence-based, trusted digital health technologies
Digital health technologies such as AI have the potential to improve cardiometabolic care; however, real-world evidence of benefit is needed to move practice forward.
Robert M. Califf
Haider J. Warraich
In February, former FDA commissioner Robert M. Califf, MD, MACC, alongside Haider J. Warraich, MD, associate director of the heart failure program at VA Boston Healthcare System and assistant professor at Harvard Medical School, and colleagues issued a special communication in JACC, which detailed important considerations for leveraging digital health technologies for cardiometabolic disease, including significant gaps in evidence and clinical integration.
“Unless we accelerate digital technology and its interface with the human part, there is no way that we can deal with a tsunami of people afflicted with this problem,” Califf said.
Digital solutions to gaps in clinical care are not regulated the same as novel drug therapies, for which there are laws requiring higher thresholds to demonstrate true efficacy and safety in large clinical trials.
“The laws for devices and digital therapies are somewhat different,” Califf said. “The standard is not proven safety and efficacy, it’s ‘reasonable likelihood of safety and efficacy.’ This has led to very different schema for most devices, particularly the kinds I am talking about today.”
Early premarket validation for digital health technologies, such as those utilizing AI and generative AI, is very different from drugs, and AI technologies are making more decisions and incorporating more and more data over time.
“The most important point here is the validation that occurs postmarket,” Califf said. “The frightening thing to a lot of people is that it’s now beyond a doubt that simply proving that it works in some postmarket setting is not adequate. It actually needs to be validated in the setting in which it’s being used.”
This can only happen if the digital health technology is embedded into the health system structure, with continuous monitoring, Califf said.
“The good news is, it’s not a technical issue. … It’s mostly an artifact of the fact that we run health systems in the United States that are fragmented on purpose to make it hard to aggregate the data that you need to actually do the measurements,” Califf said. “In the midst of all of this, our patients who are already suspicious and not having the [health care] experience we’d like them to have are at home getting fed misinformation. … If we are going to integrate digital technology into reliable health care, we’re going to need to have a shift in the way the population thinks about the health care system at a time when all of the thinking is going in the opposite direction.”
Nutrition security and cardiometabolic health
“Food is Medicine” is not a new concept with regard to CV care; however, novel strategies and emerging initiatives may improve nutrition security and equity in maintenance of cardiometabolic health, according to a state-of-the-art review published in JACC.
Katie Garfield, JD, director of whole person care at the Center for Health Law and Policy Innovation at Harvard Law School, discussed food is medicine initiatives and emerging policies to support access to Food is Medicine.
“We now see a movement to actually address [nutrition as a driver of cardiometabolic disease], through the provision of a range of nutrition support services known as ‘Food is Medicine’ or ‘nutrition supports,’” Garfield said. “We define it as food-based nutritional interventions integrated within health systems to treat or prevent disease and advance health equity. … It’s important for cardiology care teams and other clinicians to become familiar with this growing field and its potential to improve patient outcomes.”
Dariush Mozaffarian
Garfield, Dariush Mozaffarian, MD, DRPH, cardiologist, public health scientist and director of the Food is Medicine Institute at the Friedman School of Nutrition Science and Policy at Tufts University, and colleagues provided the following examples in their review document of Food is Medicine strategies to improve cardiometabolic health:
- medically tailored meals tailored to the needs of the recipient by a registered dietitian nutritionist (RDN);
- medically tailored groceries that are preselected, often by an RDN or other qualified professional, and provided to eligible patients;
- produce prescriptions for discounted or free produce, such as fresh fruits and vegetables;
- government nutrition security programs to screen, connect and support appropriate individuals into federal nutrition programs; and
- population-level healthy food programs and policies address systems and environmental barriers to equitable healthy food.
“While evidence is encouraging regarding the impact of these services, lack of consistent coverage and reimbursement can create a barrier to integration in care. Food as medicine interventions have not historically been a part of standard baseline benefits in any federal health care program,” Garfield said. “However, we are increasingly seeing these services ‘making it in through the windows.’ By that I mean Food is Medicine services are making their way into our health care payment systems through narrower policy pathways, which are typically optional to states and individual plans.”
Results of the Look AHEAD ancillary study
Intensive lifestyle therapy with weight loss for patients with diabetes reduced levels of cardiac biomarkers associated with risk for atherosclerotic CVD events and HF, a speaker reported.
Ambarish Pandey
Ambarish Pandey, MD, MSCS, associate professor of internal medicine, division of cardiology and geriatrics, co-principal investigator of the Cardiometabolic Research Unit at UT Southwestern Medical Center, presented the results of the Look AHEAD cardiac biomarker ancillary study, which were also published in JACC.
Kershaw V. Patel
Pandey, Kershaw V. Patel, MD, MSCS, assistant professor of cardiology at Houston Methodist, Weill Cornell Medical College, and colleagues conducted the present trial to assess the effects of an intensive lifestyle intervention vs. diabetes support and education on N-terminal pro-B-type natriuretic peptide and high-sensitivity cardiac troponin T and the impact of those changes on CV outcomes in patients with diabetes.
The trial enrolled nearly 4,000 patients with diabetes who underwent testing for NT-proBNP and high-sensitivity cardiac troponin T at 1 and 4 years.
The goal of the intensive lifestyle intervention was weight loss of at least 7% through diet modification and physical activity. The diabetes support and education intervention included group sessions with a focus on social support, diet and exercise.
At baseline, the mean NT-proBNP was 77 ng/L and mean high-sensitivity troponin T was 10.7 ng/L.
Compared with the diabetes support and education intervention, intensive lifestyle intervention was associated with an increase in NT-proBNP at 1 year (geometric mean ratio [GMR] = 1.14; 95% CI, 1.08-1.2), but the difference disappeared by 4 years (GMR = 1.01; 95% CI, 0.96-1.07), whereas high-sensitivity cardiac troponin T was lower at both 1 year (GMR = 0.94; 95% CI, 0.91-0.97) and 4 years (GMR = 0.93; 95% CI, 0.9-0.96).
The researchers reported that every 1 standard deviation (SD) increase in NT-proBNP was associated with higher risk for ASCVD events (HR = 1.14; 95% CI, 1-1.3; P = .04) and incident HF (HR = 1.82; 95% CI, 1.4-2.36; P < .001).
Moreover, every 1 SD increase in high-sensitivity cardiac troponin T was associated with increased risk for ASCVD events (HR = 1.48; 95% CI, 1.11-1.97; P = .007) but not incident HF (P = .75).
“Among patients with type 2 diabetes in the Look AHEAD trial, longitudinal increases in NT-proBNP were associated with high risk of composite ASCVD and even stronger risk of incident heart failure. … Intensive lifestyle intervention and weight loss were associated with a short-term increase in NT-proBNP, which attenuated over time in the 4-year follow-up,” Pandey said during the presentation.
Phase 3 results of the ARISE-HF trial
Jose L. Lopez, MD, chief cardiovascular disease fellow at the University of Miami/JFK Medical Center, presented the phase 3 results of the ARISE-HF study, which was designed to test the efficacy of an aldose reductase inhibitor (AT-001, Applied Therapeutics) for change in exercise capacity in 691 patients with diabetic cardiomyopathy (mean age, 67 years; 50% women).
For the present analysis, Lopez and colleagues evaluated racial/ethnic differences among patients with diabetes, structural heart disease and impaired exercise capacity.
For the most part, baseline characteristics were similar between race/ethnic groups with diabetic cardiomyopathy; however, use of ACE inhibitors, angiotensin II receptor blockers, SGLT2 inhibitors and GLP-1s was significantly lower among Black and Hispanic individuals vs. white individuals.
At baseline, Black and Hispanic individuals had lower Physical Activity Scale for the Elderly (PASE) and Kansas City Cardiomyopathy Questionnaire (KCCQ) scores compared with white individuals.
In addition, Black and Hispanic race were independent predictors of reduced peak VO2 at baseline.
Despite having lower baseline peak VO2, treatment of diabetic cardiomyopathy with AT-001 was associated with proportionate improvement in O2 consumption as well as improved PASE and KCCQ scores among Black and Hispanic individuals.
“Racial and ethnic differences exist in baseline characteristics of people affected with diabetic cardiomyopathy, in particular Black and Hispanic participants. They have lower use of diabetic medications, they have poorer ventricular function, lower activity status and they have lower levels of peak VO2,” Lopez said during the presentation. “There’s an obvious heterogeneity in the use of SGLT2s and GLP-1s.”
For more recent cardiometabolic research updates, read our coverage here.
References:
- Garfield G, et al. Joint Session – JACC. Presented at: Heart in Diabetes CME Conference; June 6-8, 2025; Philadelphia.
- Lopez J RM, et al. Joint Session – JACC. Presented at: Heart in Diabetes CME Conference; June 6-8, 2025; Philadelphia.
- Lopez J, et al. J Am Coll Cardiol. 2024;doi:10.1016/j.jacc.2024.04.053.
- Mozaffarian D, et al. J Am Coll Cardiol. 2024;doi:10.1016/j.jacc.2023.12.023.
- Pandey A, et al. Joint Session – JACC. Presented at: Heart in Diabetes CME Conference; June 6-8, 2025; Philadelphia.
- Patel KV, et al. J Am Coll Cardiol. 2025;doi:10.1016/j.jacc.2024.11.004.
- Warraich HJ, et al. J Am Coll Cardiol. 2025;doi:10.1016/j.jacc.2024.10.075.
Sources/Disclosures
Collapse
Califf RM, et al. Joint session – JACC. Presented at: Heart in Diabetes CME Conference; June 6-8, 2025; Philadelphia.
Disclosures:
Look AHEAD was funded by an investigator-initiated grant from Roche Diagnostics. The ARISE-HF trial was sponsored by Applied Therapeutics. Califf and Pagidipati report various financial ties to industry. Garfield reports receiving research funding from the Brystol Myers Squibb Foundation, Builders Initiative Foundation, Food is Medicine Coalition, Kaiser Permanente East Bay Community Foundation, Rockefeller Foundation and Walmart Foundation. Mozaffarian reports receiving research funding from the Gates Foundation, Kaiser Permanente East Bay Community Foundation, and Rockefeller Foundation; received personal fees from Acasti Pharma and Barilla; serving on advisory boards of Beren Therapeutics, Brightseed, Calibrate, Elysium Health, Filtricine, HumanCo, Instacart Health, January Inc., Perfect Day, Season Health and Validation Institute; holding equity in Calibrate and HumanCo; and receiving chapter royalties from UpToDate. Lopez reports no relevant financial disclosures. Pandey reports receiving research support from Applied Therapeutics, Gilead Sciences, Roche and Ultromics; honoraria as an advisor/consultant for Acorai, Bayer, Cytokinetics, Edward Lifesciences, Eli Lilly USA, Emmi Solutions, Encarda, Kieele Health, Medtronic, Merck, Novo Nordisk, Rivus, Roche Diagnostics, Sarfez Pharmaceuticals, Science37, Semler Scientific, Tricog Health and Ultromics; and receiving nonfinancial support from Merck and Pfizer. Patel reports consulting for Novo Nordisk.
link
:max_bytes(150000):strip_icc()/5-Best-High-Protein-Foods-for-Gut-Health-e20263c85fd149e28d0fe01f0a26d514.jpg "The 5 Best High-Protein Foods for Gut Health")
:max_bytes(150000):strip_icc()/The-Underrated-Proteins-You-Should-Be-Eating-If-You-Have-Diabetes-95eee4ccd3bc457bbd76fc268499f6e6.jpg "The Best Proteins for Kidney Health & Diabetes")
