The CLVer study (NCT04233034), a randomized clinical trial, investigated whether intensive blood sugar control at the time of diagnosis could preserve insulin-producing cells in children with new-onset type 1 diabetes. Conducted by researchers at the Barbara Davis Center for Diabetes at the University of Colorado, the study utilized advanced diabetes technology, including the MiniMed 780G and Tandem Control-IQ insulin pumps, to achieve tight glycemic control. While the primary goal of preserving beta cell function was not met, the study provided valuable insights into the effectiveness of early and intensive diabetes management.
Intensive Control and Beta Cell Function
According to Greg Forlenza, MD, a pediatric endocrinologist involved in the study, the initial aim was to determine if early, intensive blood sugar control could protect the cells responsible for insulin production. However, the study revealed that this approach did not yield the anticipated outcome. "Our goal in that study was to see if really intensive blood sugar control at diagnosis would preserve the cells that make insulin," Forlenza explained. "And we found that it did not, which is not what we were aiming to find, but it is a finding."
Glycemic Control Achieved
Despite the lack of beta cell preservation, the CLVer study demonstrated remarkable success in achieving target blood sugar levels. Participants using the advanced insulin pump systems were able to maintain blood sugar levels within the target range for over 80% of the time during the first year after diagnosis. This represents a significant improvement compared to historical data, where individuals with type 1 diabetes typically spent approximately 50% of their time within the target range. Newer tools had previously increased this to around 65%.
Psychological Benefits and Quality of Life
Beyond glycemic control, the study also highlighted the psychological benefits of achieving high time-in-range. Forlenza emphasized the positive impact on families, noting that the ability to consistently maintain blood sugar levels within the target range can empower both children and their families. "It gets to something that we want to study more, which is the psychological benefit of families being able to say, 'this is, for me, I can do this,'" Forlenza said. "'80% time and range is my normal, and I’m able to do that.' That is something that I want all kids to be able to achieve."
The CLVer study underscores the importance of integrating advanced diabetes technologies early in treatment, offering improved glycemic control and enhancing quality of life for children and their families. According to Forlenza, "The kids doing well and being successful and being happy with their therapy was very positive. And so that, to me, was a worthwhile reason for doing the study."
