The pilot 4T study showed consistent hemoglobin A1C improvement in all children with type 1 diabetes (T1D) after 1 year, underscoring the importance of early continuous glucose monitoring (CGM) following diagnosis, explained David Maahs, MD, PhD, professor of pediatrics at Stanford University and division chief of pediatric endocrinology at Lucile Packard Children’s Hospital.
David Maahs, MD, PhD, professor of pediatrics at Stanford University and division chief of pediatric endocrinology at Lucile Packard Children’s Hospital, explains key results of the pilot 4T study, which focuses on teamwork, targets, technology, and tight control in newly diagnosed type 1 diabetes (T1D). Maahs also explains how other research ties in with these findings, inlcuding a study that highlighted unequal access to new diabetes technology in the United States.
What were some of the main findings from the 4T study?
The 4T study is designed to try to accelerate the translation of these newly developed diabetes technologies, from research projects into clinical care. Several advances that we're able to make in this one is to start all children with type 1 diabetes on continuous glucose monitoring very early after diagnosis—on average about 7 to 10 days after they were diagnosed. So that saves them having to poke their finger. It also provides a safety net of knowing what's going on with your glucose values to help avoid low blood sugars or hypoglycemia. Also to try to avoid those higher blood glucose values as well.
Another aspect of that study then is that we're able to get that data and get it off the cloud and into what we call a population health database that was designed by our engineering colleagues here at Stanford, in collaboration with their certified diabetes care and education specialists or CDCES. And with that dashboard, we're able to then see that data and know how much time in range each person in the study has; if they're having low blood sugars, high blood sugars; if they aren't on their CGM, and often we've found out then that people were having challenges with insurance and getting their CGM covered, and so we're able to help with that. So it provides an opportunity in between clinic visits to be able to help patients and their families if they're having high sugars or low sugars, and to be able to help educate them and advise on insulin doses. The focus really is on the first year after diagnosis when families really need that extra support. And then we hope that with that extra education in that first year, that that carries forward into the second and third years of having diabetes.
Some of the main findings so far are that, in our pilot study, we saw over a half a percent reduction [of] hemoglobin A1C at 1 year, and about 63% of time in the target range of 70 to 180, while having very, very low amounts of hypoglycemia or glucoses less than 70. So those are really positive findings. A second finding that we reported just recently in the last couple of weeks in JAMA Network Open is that we were very specific to make sure that all children with type 1 diabetes could benefit from having access to this program. So when we looked at the data based on whether you had public insurance or private insurance, whether you were English speaking or Spanish speaking, that everyone got a similar benefit or a similar reduction in their hemoglobin A1C at 1 year. We were pleased to see that, that everyone was benefiting. Now, there's still some gaps in achieved A1C, and we have a lot more work that we need to do. However, the introduction of technology in this dataset was equitable, and also everyone benefited similarly for it.
In the past, there have been some studies, and Dr. Ananta Addala was the lead author on a paper that we did with data from the Type 1 Diabetes Exchange, it's a large registry in the US, and the DPV [Diabetes Prospective Follow-up] registry, which is a large registry in Germany and Austria. What was found in that paper by Addala and Auzanneau—the lead author from Germany—is that in Germany, when diabetes technology was introduced, everyone had a very similar benefit and improvement because there was very equal access to diabetes technology in Germany and Austria. In the US, there was not equal access to having new diabetes technology, and as diabetes technology was introduced, there was actually a widening in the gap of A1C between people who got technology and people who didn't get technology. So I think as a follow-up to that, our paper in JAMA Network Open shows that it is possible to have equitable access and similar improvements in A1C. Still have work to do, but I think it's encouraging.