OBJECTIVE: To evaluate the effects of two different glargine insulin delivery methods (pen device vs. vial/syringe) on glycemic control and patient preferences in a randomized, open-label, crossover, comparative effectiveness study. METHODS:Thirty-one patients discharged from the hospital were recruited for this study. In the hospital, all patients were treated with a basal-bolus insulin regimen. Upon discharge, 21 patients received glargine by pen device for 3 months and were then switched to vial/syringe for the next 3 months (group 1). Group 2 consisted of 10 patients discharged on vial/syringe and converted to pen device after 3 months. Hemoglobin A1c (HbA1c) was measured at enrollment and at 3 and 6 months. A questionnaire assessing patient preference was administered at 3 and 6 months. RESULTS: Groups 1 and 2 had similar baseline HbA1c (10.7 ± 2.2% and 11.2 ± 2.5%, respectively) and similar reduction in HbA1c at 3 months (7.8 ± 1.7% and 7.3 ± 1.4%, respectively; P<.001 vs. baseline). However, after crossover, the changes in HbA1c from 3 to 6 months were significantly different between groups. HbA1c increased to 8.5 ± 2.0% at 6 months in group 1 after switching to the vial/syringe but remained unchanged (7.1 ± 1.6%) in group 2 after switching to a pen device (P<.01, group 1 vs. group 2). Patient questionnaires after each phase of the trial revealed that patients found the pen device more convenient and were more likely to recommend this insulin delivery method to someone else. CONCLUSION: Patients switching to a glargine pen device achieved lower HbA1c at the 6-month follow-up. Patients in both groups overwhelmingly preferred glargine pens over vials/syringes.
RCT Entities:
OBJECTIVE: To evaluate the effects of two different glargine insulin delivery methods (pen device vs. vial/syringe) on glycemic control and patient preferences in a randomized, open-label, crossover, comparative effectiveness study. METHODS: Thirty-one patients discharged from the hospital were recruited for this study. In the hospital, all patients were treated with a basal-bolus insulin regimen. Upon discharge, 21 patients received glargine by pen device for 3 months and were then switched to vial/syringe for the next 3 months (group 1). Group 2 consisted of 10 patients discharged on vial/syringe and converted to pen device after 3 months. Hemoglobin A1c (HbA1c) was measured at enrollment and at 3 and 6 months. A questionnaire assessing patient preference was administered at 3 and 6 months. RESULTS: Groups 1 and 2 had similar baseline HbA1c (10.7 ± 2.2% and 11.2 ± 2.5%, respectively) and similar reduction in HbA1c at 3 months (7.8 ± 1.7% and 7.3 ± 1.4%, respectively; P<.001 vs. baseline). However, after crossover, the changes in HbA1c from 3 to 6 months were significantly different between groups. HbA1c increased to 8.5 ± 2.0% at 6 months in group 1 after switching to the vial/syringe but remained unchanged (7.1 ± 1.6%) in group 2 after switching to a pen device (P<.01, group 1 vs. group 2). Patient questionnaires after each phase of the trial revealed that patients found the pen device more convenient and were more likely to recommend this insulin delivery method to someone else. CONCLUSION:Patients switching to a glarginepen device achieved lower HbA1c at the 6-month follow-up. Patients in both groups overwhelmingly preferred glargine pens over vials/syringes.
Authors: Pieralessandro Lasalvia; Julián Esteban Barahona-Correa; Diana Marcela Romero-Alvernia; Sebastián Gil-Tamayo; Camilo Castañeda-Cardona; Juan Gabriel Bayona; Juan José Triana; Andrés Felipe Laserna; Miguel Mejía-Torres; Paula Restrepo-Jimenez; Juliana Jimenez-Zapata; Diego Rosselli Journal: J Diabetes Sci Technol Date: 2016-06-28