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 < 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.
Highlights
Inclusion criteria included a clinical diagnosis of type 2 diabetes, treatment with basal insulin for at least 6 months, with a stable dose [‡0.3 units/(kg$day); £100 units/day] maintained for at least 6 weeks; HbA1c level of 7.5%–11.0% (53–97 mmol/mol); willingness to perform self-monitoring of blood glucose (SMBG); and a body mass index (BMI) £40 kg/m2
This study demonstrated clinically significant improvements in glycemic control after the addition of mealtime insulin to a basal insulin regimen using either the patch or an insulin pen
Similar increases in body weight and low numbers of severe hypoglycemic events were observed in the two treatment arms
Summary
Type 2 diabetes is a rapidly growing epidemic, challenging health care providers and health care systems to manage its acute and long-term effects.[1,2] Despite an increasing number of treatment options, only about 50% of people with diabetes on any therapy and
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