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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.


ABSTRACT: 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?

SUBMITTER: Bergenstal RM 

PROVIDER: S-EPMC6532545 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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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.

Bergenstal Richard M RM   Peyrot Mark M   Dreon Darlene M DM   Aroda Vanita R VR   Bailey Timothy S TS   Brazg Ronald L RL   Frias Juan P JP   Johnson Mary L ML   Klonoff David C DC   Kruger Davida F DF   Ramtoola Shenaz S   Rosenstock Julio J   Serusclat Pierre P   Weinstock Ruth S RS   Naik Ramachandra G RG   Shearer David M DM   Zraick Vivien V   Levy Brian L BL  

Diabetes technology & therapeutics 20190426 5


<b><i>Background:</i></b> 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. <b><i>Methods:</i></b> Adults with type 2 diabetes (<i>n</i> = 278, age: 59.2 ± 8.9 years), were randomized to patch  ...[more]

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