TODAY studies: Young T2DM adults show serious complications

Young adults with type 2 diabetes who were followed for up to 15 years in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) studies have made an immensely important contribution to understanding the early onset form of the disease, according to clinicians and researchers at UT Health San Antonio and University Health's Texas Diabetes Institute. The studies, ‘Long-Term Complications in Youth-Onset Type 2 Diabetes’, published in the New England Journal of Medicine, showed that within 15 years of a Type 2 diabetes diagnosis, 60% of participants had at least one diabetes-related complication, and nearly a third of participants had two or more.

"Through this study, we really appreciated that Type 2 diabetes in youth is way more aggressive than the type of diabetes we see in their grandparents," said Dr Maria Rayas, assistant professor of pediatric endocrinology at UT Health San Antonio, co-investigator of the studies. "The findings are really astonishing, to think that someone in their mid-20s is already struggling with kidney disease or eye disease or another complication of diabetes.”


Study participants were ages 10-17 at the time of enrolment, had been diagnosed with Type 2 diabetes within the past two years, and were overweight or had obesity. The average age of participants after the TODAY studies follow-up was 26.


At the end of the second phase of the follow-up study (January 2020), the mean (±SD) age of the 500 participants who were included in the analyses was 26.4±2.8 years, and the mean time since the diagnosis of diabetes was 13.3±1.8 years. The cumulative incidence of hypertension was 67.5%, the incidence of dyslipidaemia was 51.6%, the incidence of diabetic kidney disease was 54.8%, and the incidence of nerve disease was 32.4%.


The prevalence of retinal disease, including more advanced stages, was 13.7% in the period from 2010 to 2011 and 51.0% in the period from 2017 to 2018. At least one complication occurred in 60.1% of the participants, and at least two complications occurred in 28.4%. Risk factors for the development of complications included minority race or ethnic group, hyperglycaemia, hypertension and dyslipidaemia. No adverse events were recorded during follow-up.


"Now we have affirmation of how bad the complications are and how rapidly they can actually occur," said Dr Elia Escaname, assistant professor of pediatric endocrinology and medical director of the children's clinic at the Texas Diabetes Institute, co-investigator of the studies. "Hopefully this study will shed light on the need for more treatment options in children, because lifestyle modification is not enough for a lot of patients."


The study also highlighted the lack of approved medications for children under 18 diagnosed with Type 2 diabetes. Beyond insulin, only metformin, liraglutide and exenatide are approved by the FDA for the treatment of Type 2 diabetes in children and adolescents ages 10-17.


"We need to expand treatment options and explore medications that we use widely for adults with Type 2 diabetes to see if they are safe and effective for children," said Rayas.


Only insulin and metformin are approved for children under 10. The TODAY findings also highlighted the study population's lack of access both to healthy lifestyles and to medications and health care providers.


"Most stayed on insulin and metformin due to costs at this final phase," said principal investigator, Dr Jane Lynch, professor of pediatric endocrinology, who noted that the burden of high medical expenses precluded the young adults from being on more-expensive medications that might more aggressively treat the diabetes.