Diabetes Registries Could Help Address Wobbly Data Dilemma

MADRID — High-quality data from European diabetes registries are essential for informed decision-making in clinical practice, research, policy, and regulation, experts said during a session at the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting on the state of diabetes registries in Europe. The session also highlighted a novel European pre–type 1 diabetes (T1D) registry.

Chantal Mathieu, MD, professor of medicine at the KU Leuven, Leuven, Belgium, co-chaired the session alongside Stefano Del Prato, MD, professor of endocrinology and metabolism at the University of Pisa School of Medicine, Pisa, Italy. “We need to convince our policymakers of the need to pay for high-quality data gathering, otherwise regulators will make decisions on wobbly data,” Mathieu said. She added that without making such a change, the World Health Organization “will advise on wobbly data, we may do research on wobbly data, and clinical decisions may be based on wobbly data. Everything depends on the quality of data we can put into our registries.”

The Value of Diabetes Registries

Kamlesh Khunti, MD, professor of primary care diabetes and vascular medicine at the University of Leicester, Leicester, England, opened the session with an introduction that reviewed the value of registries for research, clinical practice, and patients.

“Diabetes registries collect, track, and analyze patient data, and they are an essential tool for improving the quality of diabetes care and for securing better outcomes for people with diabetes,” he began.

Registries are often integrated into primary or secondary care, he continued, and can provide an evidence-based approach to diabetes management, quality control, and adherence to guidelines. They also track performance across clinics and regions to identify variation, inform delivery of care, and conduct cost analyses.

With a nod to the relatively new drugs in diabetes care, Khunti also noted the role of registries in generating real-world evidence, especially around sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 (GLP-1) receptor agonists.

“The question is whether the benefits and risks observed in registration trials are replicated in the real world,” he pointed out. “Real-world data on the SGLT2 inhibitors and GLP-1 receptor agonists show us that they are not implemented at scale, and if they are, they are often not implemented in the right people. We can monitor this and do something about it.”

However, highlighting some challenges, he noted that political will and infrastructure are necessary for optimal data use, along with real-time data collection and patient trust, to optimize the value of registries.

New European pre-T1D Registry

Anette-Gabriele Ziegler, MD, director of the Institute of Diabetes Research at Helmholtz Munich, Germany, is involved in the Fr1da study, a public health program in the state of Bavaria that screens children for islet autoantibodies. The study aims to detect T1D early so that children and their families can be educated and monitored and so that insulin therapy can be started early.

Ziegler heads the new European pre-T1D Registry, which involves a network of investigators who register children and adults diagnosed with early-stage T1D to provide information on monitoring, trials, and treatment to delay or prevent disease progression.

“We all know that type 1 diabetes is proceeded by asymptomatic autoimmunity. There is a stage I and a stage II of this phase, and we want to monitor these stages because if screening programs start to identify people with these stages of disease, then we need to ensure that care is harmonized across Europe.”

“The registry is designed to bring together pseudonymized data of people with islet autoantibodies but not yet the metabolic disease,” explained Ziegler, who added that they want to “improve the quality of clinical care in prediabetes and accelerate trial enrolment and access to disease-modifying therapy. It also aims to disseminate information to families via the investigator.”

The registry partners comprise large consortia and national registries around Europe. But this pre-T1D Registry acts as an umbrella for other pre-T1D databases, she added, citing the names of some of those already involved. These include the Global Platform for the Prevention of Autoimmune Diabetes, INNODIA (an international nonprofit organization that aims to prevent and cure T1D), European Action for the Diagnosis of Early Non-Clinical Type 1 Diabetes for Disease Interception, and Fr1da-Plex, an initiative in Germany that screens children and adolescents for islet autoantibodies to detect T1D.

“This registry is open to investigators and patients from across Europe and the United Kingdom, and you can mirror your national database into this registry,” said Ziegler.

Turning to the current dashboard, Ziegler said, “the data are very young. It only started 2 years ago, but we already have 1205 participants and 14 participating countries. By clicking on the dashboard, you can see how many participants have single or multiple autoantibodies, and this can be seen by country, age group, sex, type of autoantibody, and relative status — so if they have a relative with type 1 diabetes.”

“The last tab on the dashboard is very important because it allows you to see the metabolic data and to see if these people already have some dysglycemia or metabolic abnormality, including A1c level sometimes.”

Commenting on how to leverage registries for clinical purposes, Robert J. Heine, MD, executive medical director for Eli Lilly’s Diabetes and Endocrine Division, highlighted the European pre-T1D Registry as a particularly noteworthy example because it includes people who are not sick.

He turned to Ziegler and asked, “How do you find people to register when they are healthy, and how do you motivate parents and patients in participating?”

Ziegler replied, “We say healthy, but an underlying disease is diagnosed. These patients need monitoring so we can improve care and prevent diabetic ketoacidosis at onset and make sure that insulin is started at the right time. I see this monitoring as some type of treatment that we provide to these patients and there may be disease-modifying immunotherapies in the future, so it’s important to harmonize our procedures around this and to bring these into a registry.”

“Patients contact us and ask to be part of it because they feel safer in receiving optimized treatment and also be informed about standard of care developments in the field,” she concluded.

SWEET Registry for Pediatric Diabetes Care

Olga Kordonouri, MD, pediatric diabetologist and medical director at Children’s Hospital Auf der Bult in Hannover, Germany, introduced the SWEET registry. Started in 2008, it aims to reduce inequalities in the levels of, and access to, specialized multidisciplinary diabetes care and education.

She explained that inequalities in care usually boil down to underlying differences in systems, so a worldwide network of pediatric diabetes centers connected through common objectives and standards might help alleviate these discrepancies.

“It’s not a classical registry but an initiative or a family,” said Kordonouri. There are now 160 centers in 64 countries including Europe, Australia, North and South America, and Asia, and the database now includes data from more than 113,000 patients and over 1.3 million visits.

“Pseudonymized patient data is uploaded to the central SWEET database, and the structured collection and analysis of diabetes related patient data is carried out,” she explained.

SWEET benchmarks data involve sharing data and comparing outcomes in a noncompetitive manner and as a learning exercise, with reports available to members twice a year. “One of the real strengths is that we present and discuss results at our annual hybrid SWEET meeting, and workshops are also held to discuss certain focus areas.”

“The data are used for multicenter outcomes research to answer scientific questions. Research is a key priority for SWEET, and we now have 40 publications based on SWEET data,” she said.

Kordonouri ended with an update on the most recent SWEET data, known as SWEET-PRO (patient-related outcomes), which is a multicenter, longitudinal, observational study to assess treatment outcomes and quality of life. “Each center provides 70 randomly selected adolescents between 12 and 18 years with type 1 diabetes, and we are assessing PROs and patient-reported experience measures.”

Looking ahead, Kordonouri said the next challenge was to “enable easy data flow, including from sensors and pumps. We also need policymakers and health authorities to support and pay the personnel for data entry and transfer in every diabetes center.”

Obtaining High-Quality Data Is Essential

Co-moderator Mathieu said, “I don’t think anyone needs convincing of the importance of having solid, trustworthy data because it can guide clinicians and research as well as regulators and policymakers. The challenge is to get high-quality data, and I worry that if we rely on people having to input data manually, then we will never have enough good data.”

However, she welcomed the upcoming European guidance on extracting data from medical records and laboratory reports “because once we can eliminate the human factor, I believe we will have the real data.”

“Of course, there is also a need for monetary support to have all these data collected in registries, but I think we need to make the effort to do this,” said Mathieu. “Perhaps we need to be less ambitious and define a set of data where we will not compromise on the quality and say this is the minimum that needs to be extracted from the electronic medical records or the labs or whatever, and this needs to be in place across all European countries.”

Khunti and Zieglar had no relevant disclosures. Mathieu served on advisory panels, was a speaker, or received research support from Adocia, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Dianax, Eli Lilly, GSK, Intrexon, Janssen Pharmaceuticals, Hanmi Pharmaceutical, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, Roche Diagnostics, and Sanofi. Kordonouri received research support and speaker honoraria from Amgen, B. Braun, Diamyd Medical, Medtronic, Novo Nordisk and Sanofi and is a shareholder of DreaMed Diabetes Ltd. Heine is an employee of Eli Lilly.