medwireNews: Delivery of bolus insulin via a patch results in similar glycemic control to that delivered by a conventional pen, with improvements in treatment satisfaction and quality of life, findings from a randomized trial suggest.
The study included 278 adults with type 2 diabetes inadequately controlled on basal insulin who were randomly assigned to receive additional mealtime insulin via a patch (PAQ MEALTM, CeQur, Marlborough, Massachusetts, USA) or a conventional insulin pen, with crossover at week 44. Baseline insulin was split 1:1 between basal and bolus insulin.
Richard Bergenstal (International Diabetes Center, Minneapolis, Minnesota, USA) and co-investigators explain that the patch “is a small, wearable mechanical pump […] that can be worn on the body for up to 3 days for the delivery of mealtime insulin,” and administers a 2-unit subcutaneous dose when two buttons on the device are pressed simultaneously.
As reported in Diabetes Technology & Therapeutics, participants in both the patch and pen groups experienced a “substantial and clinically significant” reduction in glycated hemoglobin (HbA1c) from baseline to week 24, with least squares mean reductions of 1.7% and 1.6% from baseline values of 8.6% and 8.7%, respectively.
Bergenstal and colleagues note that the comparable decrease in HbA1c between the arms “met the predefined threshold for noninferiority of patch versus pen,” and that the improvements were maintained until the 44-week follow-up.
Participant-reported overall satisfaction and ease-of-use scores were significantly better for patch- versus pen-delivered insulin, and changes in quality of life from baseline to 24 weeks favored the patch method for six of seven measures.
Moreover, the results of a participant preference survey carried out at the 48-week follow-up demonstrated that a significantly higher proportion of individuals preferred the patch to the pen for all measures, among both patients who used the patch for 44 weeks and those who switched to the patch at week 44 and used it for 4 weeks.
These findings “suggest that this device can address many issues that affect adherence to mealtime insulin in real-world therapy implementation, including interference with lifestyle, daily activities, travel, social situations, embarrassment, and injection pain,” write the study authors.
They also found that the 91% of 89 healthcare providers surveyed preferred the patch to the pen method for escalating treatment from basal to basal–bolus insulin, and 89% said that it took less than 30 minutes to train participants on how to use the patch, suggesting that the device “might reduce barriers to providers recommending and implementing mealtime insulin therapy in real-world settings.”
Bergenstal et al report that “[o]verall, the patch demonstrated a good safety profile,” with a similar average bodyweight increase and a comparable proportion of patients experiencing hypoglycemia in both treatment arms. In all, 9% of patch users reported device-related adverse events at week 44, including bleeding, pain, or bruising at the injection site, the majority of which were mild in severity.
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