Children with type 1 diabetes mellitus who use insulin pumps are at a lower risk for ketoacidosis and severe hypoglycemia, compared with those receiving insulin by injection, according to a population-based cohort study from the University of Ulm, Germany.
The study participants were all younger than 20 years of age and were divided into the following groups for data analysis: 1.5-5 years; 6-10 years; 11-15 years; or 16-19 years.
The study evaluated both primary and secondary outcomes to analyze the effectiveness of insulin pumps vs. traditional insulin injections. The primary outcomes were the rates of ketoacidosis and hypoglycemia severe enough to require assistance from another person to administer intravenous carbohydrates or induce hypoglycemic coma. The secondary outcomes were serum levels of glycated hemoglobin (HbA1c), daily insulin dose, prandial to total insulin ratio, frequency of self-monitoring blood glucose level, and body mass index, according to Beate Karges, MD, of the University of Aachen (Germany), Division of Endocrinology and Diabetes, and her colleagues.
After applying selection criteria, 30,579 patients treated for type 1 diabetes were selected for analysis. Of the 30,579, a 1 to 1 matched cohort of 19,628 patients, split into equal sized groups, was created for propensity score analysis to compare the effect of treatment between insulin pumps and injects. The matched cohort was also included in the entire cohort for another propensity score analysis. Of the entire 30,579 patients, 14,119 used pump therapy and 16,460 used traditional daily insulin injections.
In the matched cohort, event rates for both severe hypoglycemia and hypoglycemic coma were much lower with insulin pumps than with traditional insulin injections (9.55 vs. 13.97 per 100 patient-years and 2.30 vs. 2.96 per 100 patient-years, respectively). The pattern of pump therapy lowering rates of severe hypoglycemia and hypoglycemic coma was observed in entire cohort as well, according to the investigators (JAMA. 2017 Oct 10;318:1358-66).
Similar results were observed in the matched cohort for ketoacidosis rates. Patients using insulin pump therapy exhibited much lower rates of ketoacidosis (2.29 vs 2.80 per 100 patient-years). The pattern of pump therapy lowering rates of severe hypoglycemia and hypoglycemic coma was observed in the entire cohort as well.
The secondary outcomes of the matched cohort did not share as consistent a pattern as the primary outcomes. HbA1c levels were lower in pump users (8.04% vs. 8.22%). Total daily insulin doses were lower in pump users, but the prandial to total insulin ratio was higher. Daily frequency of self-monitoring blood glucose level was also elevated in pump users.
“These findings provide evidence for improved clinical outcomes associated with insulin pump therapy, compared with injection therapy, in children, adolescents, and young adults with type 1 diabetes,” Dr. Karges and her colleagues wrote.
The study was funded by both the Competence Network Diabetes Mellitus and the German Center for Diabetes Research. Thomas Kapellen, MD, had received funding from the European Commission concerning closed-loop systems as well as speaking fees for pharmaceuticals companies including Abbott, Medtronic, and Novo Nordisk. No other authors reported financial conflicts.