SAN FRANCISCO — Consistently using a continuous glucose monitor may be able to lessen the time spent in hypoglycemia and hyperglycemia for children with type 1 diabetes, but the technology’s impact on time in range may be less substantial, according to findings presented at the American Diabetes Association Scientific Sessions.
“Type 1 diabetes management in the youngest children with type 1 diabetes can be very challenging, with traditional management of these children focused on avoiding hypoglycemia even at the expense of the high blood sugars or hyperglycemia. Yet, we know that hyperglycemia negatively impacts brain structure and function in young children,” Linda DiMeglio, MD, MPH, professor of pediatrics at the Indiana University School of Medicine and assistant director of clinical and translational research at the Wells Center for Pediatrics Research in Indianapolis, said during a press conference. “Therefore, we felt there was a need for a paradigm shift to address the highs as well as the lows.”
For the multicenter randomized controlled Strategies to Encourage New CGM Use in Early Childhood (SENCE) study, DiMeglio and colleagues recruited 143 children (mean age, 6 years; 50% girls; mean HbA1c, 8.2%). Participants were randomly assigned to wear a CGM and receive a familial behavioral intervention, wear CGM without the other intervention or perform blood glucose monitoring for 26 weeks.
Those in the CGM and family intervention group had an average time in range of 38% at baseline while the other two groups were at 41%. After 26 weeks, the CGM plus intervention group increased time to 42% while the CGM and blood glucose monitoring groups decreased to 40%; however, these differences both compared with baseline and compared between groups were not significant. When excluding visits prior to those at week 19 and week 26, the researchers did find that those with CGM and intervention had more time in range compared with those just using CGM (44% vs. 40%; P = .012) and compared with those using blood glucose monitoring (39%; P = .002).
“The inability to improve the time in range and HbA1c means that we have to use different approaches,” DiMeglio said. “This includes potentially changing aspects of medical nutrition therapy, doing other educational diabetes management strategies, in working with those targeted behavioral interventions and applying behavioral interventions, and there is still promise for automated insulin delivery systems in these young children.”
Before study initiation, those in the CGM plus intervention group spent a median of 3.9% of their time in a state of hypoglycemia compared with measures of 4.2% and 3.8% in the CGM and blood glucose monitoring groups, respectively. After 26 weeks, those using CGM with intervention lowered that proportion to 2.4% and those with CGM lowered it to 1.8%. whereas those using blood glucose monitoring increased time spent in hypoglycemia to 5%. The post-study differences in time in range were significant when comparing the combined CGM groups with the blood glucose monitoring group (P < .001). The blood glucose monitoring group also had more episodes of severe hypoglycemia compared with the other two groups combined (5 vs. 1; P = .02), with DiMeglio further noting that hyperglycemia time was also reduced with CGM use.
“The decreases in time spent in glycemic extremes may be associated with some neurocognitive benefits so I think that’s a good thing,” DiMeglio said. “The fact that we were able to get families to wear these consistently over 6 months suggests potential successes of other interventions applying technology in very young children.” – by Phil Neuffer
DiMeglio L, et al. Strategies to Enhance New Continuous Glucose Monitoring Use in Early Childhood (SENCE) —Primary Study Results. Presented at: American Diabetes Association 79th Scientific Sessions; June 7-11, 2019; San Francisco.
Disclosures: Some of the devices used in this study were supplied by Dexcom. DiMeglio reports she has received research support from Amgen, Caladrius Biosciences, Janssen, Medtronic and Sanofi.