Time in range similar with fast-acting vs. standard insulin for young kids with diabetes
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Key takeaways:
- Young children with type 1 diabetes had similar glycemic outcomes using fast-acting insulin aspart vs. standard insulin aspart.
- Cases of hyperglycemia with ketosis were higher with fast-acting insulin.
Fast-acting insulin aspart delivered through a hybrid closed-loop insulin delivery system provided similar glycemic outcomes as standard insulin aspart for young children with type 1 diabetes, according to study data.
In a randomized crossover trial conducted in the U.K., children aged 2 to 6 years with type 1 diabetes were randomly assigned to fast-acting insulin aspart (Novo Nordisk) and standard insulin aspart (Novo Nordisk) each for an 8-week period. Researchers found that fast-acting insulin aspart did not offer any additional glycemic benefits compared with standard insulin aspart and participants had more cases of hyperglycemia with ketosis with the fast-acting insulin.
“In this age group, closed-loop algorithms improve glycemic control primarily by reducing time in hyperglycemia, and are able to achieve this improvement with standard insulin aspart when compared to sensor-augmented pump therapy,” Julia Ware, MD, clinical research associate at the Wellcome-MRC Institute of Metabolic Science-Metabolic Research Laboratories and the Medical Research Council Metabolic Disease Unit at the University of Cambridge in the U.K. and colleagues wrote in a study published in Diabetes Technology & Therapeutics. “Fast-acting insulin aspart is only marginally faster-acting in children, and this difference may not be sufficient to provide additional benefit over and above the inherent benefit of closed-loop glucose control itself but may still confer benefit in those on standard therapies.”
Researchers enrolled 25 children aged 2 to 6 years with type 1 diabetes for at least 6 months who had been using an insulin pump for at least 3 months to participate in the trial (mean age, 5.1 years; 68% boys). Children completed a 2- to 4-week run-in period where they began using a hybrid closed-loop system with their pre-study insulin. Blood samples were collected at enrollment. After the run-in, participants were randomly assigned to fast-acting insulin aspart or standard insulin aspart for 8 weeks. At 8 weeks, all children crossed over to the other therapy. The difference between treatments in time in range between 3.9 mmol/L and 10 mmol/L was the primary outcome of the study. Secondary endpoints included mean sensor glucose, standard deviation, coefficient of variation of glucose, time spent in hypoglycemia and hyperglycemia and insulin metrics. All glycemic endpoints were collected through sensor data. Questionnaires were conducted at baseline and the end of each therapy to analyze hypoglycemia fear, diabetes distress and closed-loop treatment satisfaction. Severe hypoglycemia, diabetic ketoacidosis and other adverse events were collected.
Glycemic outcomes similar between insulin types
The study cohort had a baseline HbA1c of 7.2% and a time in range of 63.9% at the start of the trial. Of the cohort, 76% was using a hybrid closed-loop insulin delivery system at enrollment.
Time in range was similar between fast-acting insulin aspart and standard insulin aspart. No differences were seen for time spent in hypoglycemia, time spent in hyperglycemia or glucose variability. Children received slightly more insulin when using fast-acting insulin aspart compared with standard insulin aspart (0.74 U/kg per day vs. 0.72 U/kg per day; P = .04). The higher daily insulin total with fast-acting insulin aspart was due to a higher basal insulin delivery. Closed-loop usage was similar between both therapies, and sensor glucose metrics were similar during both daytime and nighttime.
Hyperglycemia with ketosis more common with fast-acting insulin
There was no difference in the levels of diabetes distress or hypoglycemia fear between the two interventions, though researchers noted a trend toward less hypoglycemia worry with fast-acting insulin aspart. There were no cases of severe hypoglycemia or DKA during either intervention. There were 30 other adverse events, with 17 occurring with fast-acting insulin aspart and eight with standard insulin aspart. Of those events, 14 were hyperglycemia events with ketosis. Nine of those 14 hyperglycemia with ketosis events took place during the fast-acting insulin aspart intervention, three took place during the run-in period and two occurred with standard insulin aspart. All of the events were resolved at home with a pump cannula change or pen correction.
“Future research should aim to trial newer ultra-rapid insulins with faster onset and offset than fast-acting insulin aspart, as improved preparations in conjunction with hybrid closed-loop therapy may well be able to confer additional clinical benefit and address some of the remaining treatment challenges in this vulnerable age-group,” the researchers wrote.
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