Super Bolus-A Remedy for a High Glycemic Index Meal in Children with Type 1 Diabetes on Insulin Pump Therapy?-A Randomized, Double-Blind, Controlled Trial

Background: This study aimed to compare whether a super bolus (SB) is a more efficient strategy than a normal bolus (NB) for high glycemic index (h-GI) meals in children with type 1 diabetes (T1D). Methods: A randomized, double-blind, crossover trial with an allocation ratio of 1:1, registered at ClinicalTrials.gov (NCT04019821). 72 children aged 10-18 years with T1D > 1 year, and on insulin pump therapy > 3 months were included. As an intervention, they ate a h-GI breakfast for the two following days and receive a prandial insulin bolus either in the form of SB or NB. Results: The SB group had lower glucose values during the observation time and lower glucose levels in 90th min (primary end point). The median time in range was also higher after SB. At the same time, more hypoglycemic episodes and a higher time below range were noted in this group. Almost 90% of them were the threshold value for initiating treatment for hypoglycemia and occurred near the end of observation period. More hyperglycemic episodes and over twice as much time in hyperglycemia were noted after NB. Conclusions: Super bolus is an effective strategy to avoid postprandial hyperglycemia but the basal insulin suspension should be longer to avoid hypoglycemia (f.ex. 3 h).