Mark Peyrot1, Richard R Rubin. 1. Department of Sociology, Loyola College in Maryland, Baltimore, 21210-2699, USA. mpeyrot@loyola.edu
Abstract
BACKGROUND: A 16-week, two-site study evaluated outcomes for a new device (the Paradigm 722 System, Medtronic MiniMed, Northridge, CA) that combines a "smart" continuous subcutaneous insulin infusion (CSII) pump with real-time (RT) continuous glucose monitoring (CGM) and CareLinktrade mark data management software (DMS). METHODS:CSII-naive adults with type 1 diabetes in suboptimal control (mean glycosylated hemoglobin [A1C] = 8.6%) were randomized to the control arm, consisting of multiple daily injections (MDI) and self-monitoring of blood glucose (SMBG), or the study arm (CSII with RT-CGM as an adjunct to SMBG). Participants (n = 28) completed the validated Insulin Delivery System Rating Questionnaire (IDSRQ) and the parallel Blood Glucose (BG) Monitoring System Rating Questionnaire (BGMSRQ) at study start and end. Participants in the study arm (n = 14) also completed newly developed User Acceptance Questionnaires (UAQs) for CSII, RT-CGM, and DMS at study end. RESULTS: A1C reduction from study start to end was significant (P < 0.05) in both arms (-1.7% for study arm;-1.0% for control arm); there was no significant change in weight in either arm. The IDSRQ showed significantly (P < 0.05) greater benefit for the study arm in convenience, acceptability of BG monitoring requirements, BG control efficacy, diabetes worries, and interpersonal hassles, as well as higher overall satisfaction/preference. The BGMSRQ showed significantly (P < 0.05) greater benefit for the study arm in the BG monitoring system's ability to help manage glycemic control and less interest in changing to another BG monitoring system. The Study Arm UAQs showed positive ratings of system features. CONCLUSIONS: Several patient-reported outcomes were significantly more positive in the study arm than the control arm; none was significantly more positive in the control arm. The features of the integrated RT-CGM/CSII system were frequently used and highly rated by participants, with high user satisfaction.
RCT Entities:
BACKGROUND: A 16-week, two-site study evaluated outcomes for a new device (the Paradigm 722 System, Medtronic MiniMed, Northridge, CA) that combines a "smart" continuous subcutaneous insulin infusion (CSII) pump with real-time (RT) continuous glucose monitoring (CGM) and CareLinktrade mark data management software (DMS). METHODS: CSII-naive adults with type 1 diabetes in suboptimal control (mean glycosylated hemoglobin [A1C] = 8.6%) were randomized to the control arm, consisting of multiple daily injections (MDI) and self-monitoring of blood glucose (SMBG), or the study arm (CSII with RT-CGM as an adjunct to SMBG). Participants (n = 28) completed the validated Insulin Delivery System Rating Questionnaire (IDSRQ) and the parallel Blood Glucose (BG) Monitoring System Rating Questionnaire (BGMSRQ) at study start and end. Participants in the study arm (n = 14) also completed newly developed User Acceptance Questionnaires (UAQs) for CSII, RT-CGM, and DMS at study end. RESULTS:A1C reduction from study start to end was significant (P < 0.05) in both arms (-1.7% for study arm;-1.0% for control arm); there was no significant change in weight in either arm. The IDSRQ showed significantly (P < 0.05) greater benefit for the study arm in convenience, acceptability of BG monitoring requirements, BG control efficacy, diabetes worries, and interpersonal hassles, as well as higher overall satisfaction/preference. The BGMSRQ showed significantly (P < 0.05) greater benefit for the study arm in the BG monitoring system's ability to help manage glycemic control and less interest in changing to another BG monitoring system. The Study Arm UAQs showed positive ratings of system features. CONCLUSIONS: Several patient-reported outcomes were significantly more positive in the study arm than the control arm; none was significantly more positive in the control arm. The features of the integrated RT-CGM/CSII system were frequently used and highly rated by participants, with high user satisfaction.
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