The Effect of Prandial Insulin Applied for Fat Protein Units on Postprandial Glucose Excursions in Type 1 Diabetes Patients with Insulin Pump Therapy: Results of a Randomized, Controlled, Cross-Over Study

Objective This randomized cross-over study aimed to compare different algorithms for calculating prandial insulin considering the fat and protein content of a standardized meal in type 1 diabetes patients using insulin pump therapy (CSII). Methods Twenty-six patients received a standardized evening meal for three consecutive days using different algorithms for insulin dose adjustment: A) exclusive consideration of carbohydrate content without considering fat-protein content, B) high-dose algorithm considering additional insulin for fat protein units (FPUs) with the same factor as for carbohydrates, and C) low-dose algorithm considering additional insulin for FPUs with half the factor as for carbohydrates. The primary outcome was the proportion of interstitial glucose values in the target range (≥ 70 to ≤ 180 mg/dl) during the post-prandial 12-hour follow-up period. Secondary outcomes were the occurrence of hypo- and hyperglycemic episodes and the coverage with carbohydrates for treatment of hypoglycemia. Results The percentage of glucose values in the target range was significantly higher when fat-protein content was not considered, whereas, in the hyperglycemic range, it did not differ significantly among the three groups. The percentage of hypoglycemic glucose values were the highest in the groups considering fat-protein content and lowest in the group not considering FPUs with no significant difference between the two groups in terms of FPUs. Conclusions In adult type 1 diabetes patients using CSII, it is not recommended to consider a high fat and protein content in the diet when calculating prandial insulin dosage with the selected algorithms, as this increases the risk of hypoglycemia disproportionately.

A Randomized Trial of Strategies Using Darbepoetin Alfa To Avoid Transfusions in CKD

BackgroundExposure to high doses or a high cumulative dose of erythropoiesis-stimulating agents (ESAs) may contribute to cardiovascular events in patients with CKD and anemia. Whether using a low fixed ESA dose versus dosing based on a hemoglobin-based, titration-dose algorithm in such patients might reduce risks associated with high ESA doses and decrease the cumulative exposure—while reducing the need for red blood cell transfusions—is unknown.MethodsIn this phase-3, randomized trial involving 756 adults with stage-3 to -5 CKD and anemia, we evaluated incidence of red blood cell transfusions for participants randomized to receive darbepoetin given as a fixed dose (0.45 µg/kg every 4 weeks) versus administered according to a hemoglobin-based, titration-dose algorithm, for up to 2 years. Participants received transfusions as deemed necessary by the treating physician.ResultsThere were 379 patients randomized to the fixed-dose group, and 377 to the titration-dose group. The percentage of participants transfused did not differ (24.1% and 24.4% for the fixed-dose and titration-dose group, respectively), with similar time to first transfusion. The titration-dose group achieved significantly higher median hemoglobin (9.9 g/dl) compared with the fixed-dose group (9.4 g/dl). The fixed-dose group had a significantly lower median cumulative dose of darbepoetin (median monthly dose of 30.9 µg) compared with the titration-dose group (53.6 µg median monthly dose). The FD and TD group received a median (Q1, Q3) cumulative dose per 4 weeks of darbepoetin of 30.9 (21.8, 40.0) µg and 53.6 (31.1, 89.9) µg, respectively; the median of the difference between treatment groups was −22.1 (95% CI, −26.1 to −18.1) µg.ConclusionsThese findings indicate no evidence of difference in incidence of red blood cell transfusion for a titration-dose strategy versus a fixed-dose strategy for darbepoetin. This suggests that a low fixed dose of darbepoetin may be used as an alternative to a dose-titration approach to minimize transfusions, with less cumulative dosing.