Implementation of Basal-Bolus Therapy in Type 2 Diabetes: A Randomized Controlled Trial Comparing Bolus Insulin Delivery Using an Insulin Patch with an Insulin Pen

Calibra Study Group, Richard M. Bergenstal (Lead / Corresponding author), Mark Peyrot, Darlene M. Dreon, Vanita R. Aroda, Timothy S. Bailey, Ronald L. Brazg, Juan P. Frias, Mary L. Johnson, David C. Klonoff, Davida F. Kruger, Shenaz Ramtoola, Julio Rosenstock, Pierre Serusclat, Ruth S. Weinstock, Ramachandra G. Naik, David M. Shearer, Vivien Zraick, Brian L. Levy

    Research output: Contribution to journalArticlepeer-review

    25 Citations (Scopus)
    190 Downloads (Pure)


    Background: Barriers to mealtime insulin include complexity, fear of injections, and lifestyle interference. This multicenter, randomized controlled trial evaluated efficacy, safety, and self-reported outcomes in adults with type 2 diabetes, inadequately controlled on basal insulin, initiating and managing mealtime insulin with a wearable patch versus an insulin pen.

    Methods: Adults with type 2 diabetes (n = 278, age: 59.2 ± 8.9 years), were randomized to patch (n = 139) versus pen (n = 139) for 48 weeks, with crossover at week 44. Baseline insulin was divided 1:1 basal: bolus. Using a pattern-control logbook, subjects adjusted basal and bolus insulin weekly using fasting and premeal glucose targets.

    Results: Glycated hemoglobin (HbA1c) change (least squares mean ± standard error) from baseline to week 24 (primary endpoint) improved (P < 0.0001) in both arms,-1.7% ± 0.1% and-1.6% ± 0.1% for patch and pen (-18.6 ± 1.1 and-17.5 ± 1.1 mmol/mol), and was maintained at 44 weeks. The coefficient of variation of 7-point self-monitoring blood glucose decreased more (P = 0.02) from baseline to week 44 for patch versus pen. There were no differences in adverse events, including hypoglycemia (three severe episodes per arm), and changes in weight and insulin doses. Subject-reported treatment satisfaction, quality of life, experience ratings at week 24, and device preferences at week 48 significantly favored the patch. Most health care providers preferred patch for mealtime insulin.

    Conclusions: Bolus insulin delivered by patch and pen using an algorithm-based weekly insulin dose titration significantly improved HbA1c in adults with type 2 diabetes, with improved subject and health care provider experience and preference for the patch.

    Original languageEnglish
    Pages (from-to)273-285
    Number of pages13
    JournalDiabetes Technology and Therapeutics
    Issue number5
    Early online date7 May 2019
    Publication statusPublished - 7 May 2019


    • Mealtime insulin patch
    • Type 2 diabetes

    ASJC Scopus subject areas

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


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