Experts Advise on Early-Risk Monitoring for Type 1 Diabetes
Orlando, Fla. — A new international consensus statement offers guidance for primary care and endocrinology providers on the care and monitoring of people who are at high risk for type 1 diabetes (T1D).
The document specifically addresses the care of both children and adults who have undergone screening and have tested positive for one or more T1D-associated islet autoantibodies. These individuals are classified as: At risk or Stage 0 (single autoantibody or transient single autoantibody), Stage 1 (two or more autoantibodies with normoglycemia), and Stage 2 (two or more autoantibodies with dysglycemia but without symptoms and not yet meeting diagnostic criteria for Stage 3 clinical T1D).
Development of the guidance was led by Breakthrough T1D (formerly JDRF) in collaboration with Advanced Technologies & Treatments for Diabetes, the American Association of Clinical Endocrinology, the American Diabetes Association, the Association of Diabetes Care and Education Specialists, the Endocrine Society, the Australian Diabetes Society, the European Association for the Study of Diabetes, and the International Society for Pediatric and Adolescent Diabetes (ISPAD). It was authored by 60 experts from 11 countries on four continents.
The document was presented on June 24, 2024 in a 90-minute symposium at the American Diabetes Association’s annual Scientific Sessions and published simultaneously in both Diabetes Care and Diabetologia.
“This is not guidance around who to screen or when to screen. This is guidance for the hundreds of thousands of people around the world who have participated in screening, mostly through research programs, and have been identified with positive autoantibodies and need care in the clinical setting,” panel co-chair Anastasia Albanese-O’Neill, PhD, APRN, CDCES, of Breakthrough T1D, told Medscape Medical News.
Just one previous recommendation, from ISPAD, covered monitoring of early-stage T1D, but it didn’t address adults and also didn’t make specific recommendations for education or psychosocial support in autoantibody-positive people, monitoring of Stage 0 (single autoantibody) individuals, or when to start insulin. The new document covers all those areas. “This was a true clinical need,” Albanese-O’Neill said.
She noted that starting October 1, 2024, three new ICD-10 codes will be available for early-stage T1D under subcategory E10-A: E10-A0 for unspecified presymptomatic T1D, E10-A1 for Stage 1, and E10.A2 for Stage 2. “It’s really a change in the clinical paradigm. We can identify people early now. And in the fall, clinicians will need to think about how they will use those codes in the clinical setting for diagnosis.”
Neil Skolnik, MD, professor of family and community medicine, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, who was not involved in developing the guidance, told Medscape Medical News, “Type 1 diabetes has a preclinical stage during which careful and specific monitoring can accomplish important goals. Specifically, those goals are that such monitoring can decrease the likelihood of the person developing diabetic ketoacidosis [DKA] and can help determine which patients are candidates for new therapies that may delay the onset of T1D.”
Skolnik, who is also director of the Family Medicine Residency Program at Jefferson Health – Abington, said that he found that the document “provides clear and helpful guidance” on how to follow people with autoantibody positivity,” adding “most of the time, in primary care that will involve co-management with an endocrinologist.”
The document includes these concepts:
- Primary care providers and endocrinologists should partner to care for people who are T1D autoantibody–positive.
- When people screen positive with one or more T1D autoantibody, a second sample should be tested for confirmation.
- Single autoantibody positivity confers a lower risk for progression than do multiple autoantibodies.
- People with early-stage T1D should have periodic medical monitoring, including regular glucose testing, regular education about symptoms of diabetes and DKA, and psychosocial support.
- People with Stage 2 T1D should be offered trial participation or approved therapies. (So far, only teplizumab (Tzield; Provention Bio) has been approved by the US Food and Drug Administration for Stage 2 T1D, but others are in development).
- All health professionals involved in monitoring and care of children and adults with T1D “have a responsibility to provide education.”
Separate detailed guidance is given regarding how and when to monitor children, adults (in whom, autoimmune diabetes typically progresses more slowly compared with children), and pregnant women, as well as in each of the three stages. The general concept is that primary care and endocrinology should partner in the earlier stages, with endocrinology taking over when people reach Stage 2 T1D because nearly 100% of these patients are guaranteed to progress to Stage 3.
The recommendations also include when to start insulin, and how to provide education and psychosocial support to individuals and family members of those given the early-stage T1D diagnosis.
Sufyan Hussain MRCP, PhD, an adult endocrinologist and clinician-scientist at King’s College London, United Kingdom, told Medscape Medical News, “This consensus guidance is an important step forward in the field. It details the steps needed by healthcare professionals, teams, and health systems to support and care for individuals identified as at risk for type 1 diabetes during screening. The emphasis on a multidisciplinary approach, the inclusion of primary care, psychosocial support and education is key.”
Albanese-O’Neill pointed out that in medicine, it’s important to know in advance what to do if an ordered test comes back positive, but for the most part, that hasn’t been the case with T1D autoantibody testing. “That’s the gap we’re trying to fill with this particular document.”
Skolnik commented, “This is not difficult to incorporate into primary care practice, though at the present time it does not come up frequently…What will be interesting in the future, given the prevalence of T1D, is whether there will be recommendations at some point for routine autoantibody screening.”
In the coming weeks, Breakthrough T1D will launch a public education campaign to encourage people to discuss T1D screening with their clinicians.
Albanese-O’Neill has no disclosures. Skolnik is on advisory boards and/or consults for AstraZeneca, Teva, Lilly, Boehringer Ingelheim, Sanofi, Sanofi Pasteur, GSK, Bayer, Genetch , Abbot, Idorsia, Novartis, Novo Nordisk, Astellas; is a speaker for AstraZeneca; Boehringer Ingelheim; Lilly, GSK, Teva, Bayer, Heartland, and Astellas; and receives research support from AstraZeneca, GSK , Novo Nordisk , Novartis
Miriam E. Tucker is a freelance journalist based in the Washington DC area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X (formerly Twitter) @MiriamETucker.
