Larry C. Deeb

Background Insulin degludec/insulin aspart (IDegAsp) is a fixed soluble co‐formulation of basal and bolus insulin. Objective To evaluate efficacy and safety of IDegAsp in pediatric patients with type 1 diabetes (T1D). Subjects Children and adolescents (aged 1–95%CI (–0.45 mmol/mol [–2.51; 1.60]_95%CI), confirming non‐inferiority. There were no significant differences between treatment groups in fasting or self‐measured plasma glucose. Confirmed hypoglycemia rates did not significantly differ between groups. There was a significant reduction in basal and total insulin dose with IDegAsp+IAsp versus IDet+IAsp (post hoc analysis). Mean number of injections/day was 3.6 and 4.9 with IDegAsp+IAsp and IDet+IAsp, respectively (post hoc analysis). A non‐significant higher rate of severe hypoglycemia was observed with IDegAsp+IAsp versus IDet+IAsp. The most frequent adverse events in both groups were hypoglycemia, headache and nasopharyngitis. Conclusions IDegAsp+IAsp was non‐inferior to IDet+IAsp regarding HbA1c, had similar hypoglycemia rates and required fewer injections.

Background: This study evaluated the performance of the DIDGET® blood glucose monitoring system (BGMS) in the hands of its intended users: Children, teens, and young adults with diabetes. Methods: Finger stick capillary blood samples were tested in duplicate by subjects (with parent/guardian assistance, if needed) and health care professionals using the DIDGET BGMS, and results were compared with those obtained using a Yellow Springs Instruments (YSI) glucose analyzer. Modified venous blood samples (i.e., glycolyzed or spiked with glucose) were used to analyze meter performance under extreme glucose concentrations. Accuracy was assessed using International Organization for Standardization (ISO) 15197:2003 guidelines (i.e., 95% of meter results within ±15 mg/dl or ±20% of reference values). Results: A total of 123 subjects aged 4 to 24 years with type 1 or type 2 diabetes were enrolled. The DIDGET meter achieved accuracy according to ISO 15197:2003 criteria: >97% of meter results were within ±15 mg/dl or ±20% of reference values. Regression analyses showed a high degree of correlation between meter and YSI results: Coefficient of determination ( R²) = 98.2% for all samples combined and 97.2% for capillary samples only. Clinical accuracy for combined samples was demonstrated by Parkes consensus error grid analyses; 100% of meter results were in zone A (98.5%) or zone B (1.5%). There was no difference in performance or accuracy across age subsets. Hematocrit values did not affect meter blood glucose results. Conclusion: The DIDGET BGMS provided accurate test results across all age ranges in children, teens, and young adults with diabetes.