Patient-reported outcomes for an integrated real-time continuous glucose monitoring/insulin pump system

Mark Peyrot, Richard R. Rubin

    Research output: Contribution to journalArticle

    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 CareLink™ 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.

    Original languageEnglish (US)
    Pages (from-to)57-62
    Number of pages6
    JournalDiabetes Technology and Therapeutics
    Volume11
    Issue number1
    DOIs
    StatePublished - Jan 1 2009

    Fingerprint

    Subcutaneous Infusions
    Blood Glucose
    Insulin
    Glucose
    Blood Glucose Self-Monitoring
    Software
    Insulin Infusion Systems
    Infusion Pumps
    Aptitude
    Glycosylated Hemoglobin A
    Type 1 Diabetes Mellitus
    Surveys and Questionnaires
    Patient Reported Outcome Measures
    Outcome Assessment (Health Care)
    Weights and Measures
    Equipment and Supplies
    Injections

    ASJC Scopus subject areas

    • Endocrinology
    • Endocrinology, Diabetes and Metabolism
    • Medical Laboratory Technology

    Cite this

    Patient-reported outcomes for an integrated real-time continuous glucose monitoring/insulin pump system. / Peyrot, Mark; Rubin, Richard R.

    In: Diabetes Technology and Therapeutics, Vol. 11, No. 1, 01.01.2009, p. 57-62.

    Research output: Contribution to journalArticle

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