Year in Review: The Biggest News in Diabetes Clinical Science
Coverage of the American Diabetes Association (ADA) Scientific Sessions is brought to you by the ADA x BT1 Collab.
Presentation: The Year in Review—Highlights of the Past Year in Basic, Translational, and Clinical Science
Speakers at this ADA Scientific Sessions presentation included: David D’Alessio, MD, (Duke University Medical Center), Linda DiMeglio MD, MPH, (Indiana University School of Medicine), Silvia Corvera, MD, (University of Massachusetts Medical School), Desmond Shatz, MD, (University of Florida)
This article focuses on highlights in clinical science in the last year, as presented by Dr. Linda DiMeglio.
A landmark year for diabetes treatment
It’s been 100 years since the discovery of insulin—the life-sustaining treatment marking a breakthrough in treating diabetes. At the time, the patent was sold for just $1 to the University of Toronto, with the intention of making insulin accessible. Yet, a century later the cost of diabetes care and insulin is a growing burden for people with diabetes across the globe.
Read more: Nature Medicine: “100 years of insulin: celebrating the past, present and future of diabetes therapy”
Journal of Endocrinology: “100 Years of Insulin: Arresting or curing type 1 diabetes: an elusive goal, but closing the gap”
Antidiabetic drugs to treat type 2 diabetes have advanced rapidly
There have been rapid advancements in available drugs to treat type 2 diabetes (T2D). Humalin R and Humalin N insulins were first approved in the early 1980s. The number of new drug treatments has grown and has particularly accelerated in the last 15 years, the latest being Mounjaro approved in May. Today, there are nearly 60 drugs approved to treat T2D and nearly 100 more drugs in clinical trials.
The growing understanding of T2D as a complex disease with many genetic factors and root causes is “creating a push towards more personalized and accessible treatments,” the authors write.
Read more: Frontiers of Pharmacology: “Trends in Antidiabetic Drug Discovery: FDA Approved Drugs, New Drugs in Clinical Trials and Global Sales”
Changes in diagnosis guidelines
In January, guidelines were updated to expand screening for prediabetes and type 2 diabetes as a result of a 2021 paper.
- Screen adults, regardless of age, who are overweight or living with obesity and have one or more additional risk factors for pre-diabetes and T2D.
- Beginning at age 35, screen any adults living with obesity or who are overweight, and screen every three years.
Maturity onset diabetes of the young (MODY) is a genetic form of diabetes that has characteristics of both type 1 and type 2. New guidelines suggest children and young adults who have a family history of diabetes in successive generations should have genetic testing for MODY, even if they don’t have symptoms of type 1 or type 2 diabetes.
This update is important because it will help get genetic testing covered by insurers.
Read more: JAMA: “Screening for Prediabetes and Type 2 Diabetes: US Preventive Services Task Force Recommendation Statement”
Diabetes Care: “The Management of Type 1 Diabetes in Adults. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)”
Changes to T2D Standards of Care
This year brought an update to the standards of care for T2D at diagnosis, expanding recommendations to individualize the treatment approach to a patient’s unique needs and circumstances.
In 2021, the first-line therapy for T2D was metformin with comprehensive lifestyle changes, which may include weight management and exercise.
This year treatment guidelines were expanded. Now, first-line therapy “depends on comorbidities, patient-centered treatment factors, including cost and access considerations and management needs and generally includes metformin and comprehensive lifestyle.”
For example, a provider may start a newly diagnosed person who also has high cardiovascular risk or Chronic Kidney disease on a GLP-1 or SGLT-2 inhibitor instead of metformin.
There is strong evidence supporting this shift to more personalized approaches to T2D management.
New products hit the market
2021 brought some new insulin products to the market:
- ReliOn™ NovoLog® was introduced by Walmart in June 2021 and offers significant cost savings.
- In July, the U.S. Food and Drug Administration (FDA) approved Semglee as the first interchangeable biosimilar product, meaning pharmacists can substitute Semglee for Lantus or other long-acting insulin glargine. However, Semglee did not offer cost savings when paying cash as hoped.
- Rezvoglar was also approved as a long-acting biosimilar in December, though it doesn’t appear to be widely available yet.
DiMeglio noted biosimilars are most often available in pre-loaded pens, making them harder to dose for some people, including children. Expanding biosimilar products to be available in vials is key for accessibility.
“We also have to think about making biosimilars available in forms that are useful for everybody,” DiMeglio said.
The Gvoke Kit—ready-to-inject liquid glucagon in a vial and syringe kit was approved in August 2021. Previously, this form of liquid glucagon came in a HypoPen® or Gvoke PFS® pre-filled syringe only. The Gvoke Kit and pre-filled syringe both allow for mini-dosing if a full dose of glucagon isn’t necessarily appropriate.
At approximately $300 for the Kit, the newest option is about half the cost of the Gvoke PFS when paying out of pocket.
New T2D drugs
Kerendia (finerenone) was approved for people with T2D who don’t tolerate SGLT-2 inhibitors.
Mounjaro (tirzepatide), a new drug by Lilly Diabetes, has had six studies showing promising results in treating T2D and obesity. Currently, it costs over $12,000 per year out of pocket.
Read More: Diabetes Care: “Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes According to Baseline HbA1c and Insulin Use: An Analysis From the FIDELIO-DKD Study”
Molecular Metabolism: “LY3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: From discovery to clinical proof of concept”
Lancet: “Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial
New England Journal of Medicine: “Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes”
A recent study showed a closed-loop system was effective in helping very young children. In the study which focused on children under 6, users of the closed-loop systems had increased time-in-range and decreased A1c.
Read more: New England Journal of Medicine: “Randomized Trial of Closed-Loop Control in Very Young Children with Type 1 Diabetes”
Omipod 5—the only tubeless closed-loop insulin pump system—was approved for people ages 6 and up. “I think this will make a difference in lowering A1c and improving quality of life for people with diabetes,” DiMeglio said.
Additionally, two continuous glucose monitors on the market saw advances in their sensors:
- The six-month implantable sensor, Eversense by Senseonics, was approved by the FDA for people over 18.
- The FreeStyle Libre 3 was updated with a very small sensor—the size of two stacked pennies—and approved for ages 4 and up.
New guidelines on closed-loop systems
Last year, an international consensus paper urged healthcare providers to respect the autonomy of people with diabetes and caregivers using DIY-loop systems.
“We need to have a respect for autonomy and support the rights that people with diabetes or their caregivers informed decision about their own care. This is important in general but also important for in this context around people using open-source devices so that we need to be able to support people with diabetes or their caregivers who choose to use these approaches.” the paper states.
The standards of care, this year, acknowledge that people may be using closed-loop systems not approved by the FDA—specifically DIY systems developed by the patient community—and recommends providers “assist in diabetes management to ensure patient safety” in regards to these systems.
Read more: The Lancet Diabetes and Endocrinology: “Open-source automated insulin delivery: international consensus statement and practical guidance for health-care professionals”