AIMS: This study evaluated treatment satisfaction, comfort, and function using the wireless OmniPod™ Insulin Management System (Insulet Corp., Bedford, MA) compared with conventional (infusion set) insulin pumps in young adults with type 1 diabetes. RESEARCH DESIGN AND METHODS: Twenty-nine patients (age, 24.0± 5.1 years; diabetes duration, 12.1 ± 5.7 years; insulin pump duration, 6.4 ± 3.1 years; glycated hemoglobin [HbA1c], 8.6 ± 0.7%) participated in a randomized, two-arm open crossover study comparing two consecutive 12-week periods of continuous subcutaneous insulin infusion (CSII): one period using the OmniPod system and the other period using conventional CSII. The main outcome measures were treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire), user evaluation (OmniPod System User Evaluation Questionnaire), and HbA1c levels. RESULTS:Treatment satisfaction at baseline was high, with a mean score of 28.6±4.6 (maximal score, 36) and no significant difference between the two randomized groups. Upon completion of the study period 43% "would switch to OmniPod," 36% were "undecided," and 21% "would not switch pumps." Seventy-six percent preferred the OmniPod automated cannula insertion system, and 56% reported that OmniPod fit better into their lifestyle than conventional CSII. HbA1c levels significantly decreased with both OmniPod and conventional CSII (7.9 ± 0.9% vs. 8.8 ± 0.7% and 8.2 ± 0.9% vs. 8.5 ± 0.5%, respectively; P<0.001 for both groups) after completion of the first treatment arm. The decrease in HbA1c was more marked in the OmniPod group (P=0.044), without additional improvement at the end of the study in either group. CONCLUSIONS: The OmniPod system was well received by young adults with type 1 diabetes experienced with conventional CSII.
RCT Entities:
AIMS: This study evaluated treatment satisfaction, comfort, and function using the wireless OmniPod™ Insulin Management System (Insulet Corp., Bedford, MA) compared with conventional (infusion set) insulin pumps in young adults with type 1 diabetes. RESEARCH DESIGN AND METHODS: Twenty-nine patients (age, 24.0 ± 5.1 years; diabetes duration, 12.1 ± 5.7 years; insulin pump duration, 6.4 ± 3.1 years; glycated hemoglobin [HbA1c], 8.6 ± 0.7%) participated in a randomized, two-arm open crossover study comparing two consecutive 12-week periods of continuous subcutaneous insulin infusion (CSII): one period using the OmniPod system and the other period using conventional CSII. The main outcome measures were treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire), user evaluation (OmniPod System User Evaluation Questionnaire), and HbA1c levels. RESULTS: Treatment satisfaction at baseline was high, with a mean score of 28.6±4.6 (maximal score, 36) and no significant difference between the two randomized groups. Upon completion of the study period 43% "would switch to OmniPod," 36% were "undecided," and 21% "would not switch pumps." Seventy-six percent preferred the OmniPod automated cannula insertion system, and 56% reported that OmniPod fit better into their lifestyle than conventional CSII. HbA1c levels significantly decreased with both OmniPod and conventional CSII (7.9 ± 0.9% vs. 8.8 ± 0.7% and 8.2 ± 0.9% vs. 8.5 ± 0.5%, respectively; P<0.001 for both groups) after completion of the first treatment arm. The decrease in HbA1c was more marked in the OmniPod group (P=0.044), without additional improvement at the end of the study in either group. CONCLUSIONS: The OmniPod system was well received by young adults with type 1 diabetes experienced with conventional CSII.