A new way to introduce multiple injections with the use of an insulin patch.
An insulin patch can safely provide similarly effective glycemic management in adults with type 2 diabetes compared with a standard insulin pen, according to findings published in Diabetes Technology & Therapeutics.
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.
Richard M. Bergenstal, MD, executive director of the International Diabetes Center Park Nicollet in Minneapolis, and colleagues wrote, “Patient barriers to insulin use include fear of injections, perceived social stigma, interference with daily activities, reduced quality of life and increased cost…. Some technological advances to simplify insulin delivery may address some of the abovementioned barriers. In recent years, a number of wearable devices have been designed and developed to deliver basal and/or mealtime insulin.”
The patch. The wearable, on-demand, mealtime insulin-delivery system patch (Calibra Medical, Wayne, PA) contains up to 200 units of insulin and measures no more than 65 × 35 × 8 mm. It can be worn on the abdomen for up to 3 days. Mealtime insulin can be dosed in 2-unit increments through clothing by actuating the buttons on both sides of the patch. The comparator device was a NovoLog/NovoRapid FlexPen® (insulin aspart) (Novo Nordisk Pharmaceuticals, Inc., Princeton, NJ).
For the study, 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.
Compared with baseline measures, at the halfway point (24 weeks), participants using the patch had a similar reduction in HbA1c (–1.7%) as the participants using the pen (–1.6%), and these measures were maintained at 44 weeks as well. The researchers further found that a similar number of those who used the patch decreased their HbA1c level below 7% (65%) compared with those who used a pen (63%) at 44 weeks.
After 44 weeks, each group reported the same number of hypoglycemic events (three), and rates of adverse events were not significantly different, the researchers wrote. There was no significant difference in adherence rates for those who used the patch and those who used the pen at 24 weeks (79% vs. 78%, respectively) and 44 weeks (81% vs. 81%), but those who used the patch reported higher satisfaction (P< .01) at 24 weeks compared with those who used the pen. In addition, the patch was favored by more than 90% of health care providers compared with the pen.
“These factors, combined with health care provider recognition of the positive experience of subjects using the patch, might reduce barriers to providers recommending and implementing mealtime insulin therapy in real-world settings,” the researchers wrote. “If clinical inertia can be reduced, patients may benefit from reduced exposure to hyperglycemia, which is likely to reduce the risk of diabetes complications.”
The results showed that 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.
From the results it was concluded that a 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.
- An insulin patch is as effective as multiple injections with a pen
- Insulin Patch proves effective for adults when moving to multiple daily injections
- Using the patch can reduce barriers to providers recommending and implementing mealtime insulin therapy.