In patients with uncontrolled diabetes receiving moderately high doses of basal insulin, the addition of mealtime insulin using either an insulin patch or a conventional insulin pen resulted in clinically significant improvement in glycemic control, according to study results published in Diabetes Technology & Therapeutics.
Insulin therapy is usually given with a basal formulation aiming to control the fasting plasma glucose level, however, timely addition of mealtime insulin is important. There are several barriers to insulin use, such as fear of injections, but some may be overcome with new advances in technology designed to simplify insulin delivery. One such device is the insulin patch (PAQ MEAL™; CeQUR, Marlborough, MA), which delivers mealtime insulin. Unlike insulin pens, the patch does not require an injection, and unlike insulin pumps, there is no external controller managing the treatment.
In this study, the researchers assessed the efficacy and safety of the patch compared with a conventional insulin pen for initiating and managing mealtime analog insulin in patients with uncontrolled type 2 diabetes receiving basal insulin alone or in combination with other antihyperglycemic agents.
The study enrolled 278 participants (60% men; mean age, 59.2 years) between July 2015 and August 2016. Participants were randomly assigned to use either the patch (n = 139) or the pen (n = 139). Of these patients, 241 (87%) completed assessment through 24 weeks and 216 (78%) completed assessment through 44 weeks.
The least squares mean change in hemoglobin A1c level from baseline to week 24 was significant with both insulin patch and pen (-1.7% vs -1.6%, respectively; P <.0001), meeting the predefined threshold for noninferiority of patch vs pen (P <.0001). The improvement in glycemic control was also evident from baseline to week 44 (-1.6% in both groups).
At week 24, 63% of patch users and 56% of pen users achieved hemoglobin A1c levels of ≤7% (P =.26). The least squares mean change in fasting plasma glucose from baseline to week 24 was significant in both groups.
The coefficient of variation for 7-point self-monitoring of blood glucose values (3 preprandial, 3 postprandial, 1 bedtime) decreased significantly more from baseline to week 44 in the group of patients using the insulin patch compared with those using the conventional insulin pen (mean change, -2.6% ± 1.1%; 95% CI, -4.8 to -0.4; P =.022).
Compared with pen use, the patch demonstrated a good safety profile, with no serious adverse device-related events and a similarly low percentage of study-related adverse events (1.5% vs 0.7%, respectively). Adverse events at week 44 were similar in patch and pen users (71.9% and 71.2%, respectively). Serious adverse events were reported in 7.2% and 9.4% of patients, respectively, but most were unrelated to intensifying insulin therapy.
The patch offered better quality of life and higher device satisfaction compared with mealtime insulin injection. At week 48, significantly more participants preferred the patch to the pen and most stated they would like to switch from the pen to the patch.
Most healthcare providers (91.1%) preferred the patch to the pen for patients requiring the addition of mealtime insulin. They reported the patch was easy to use and required a short training time for patients.
The researchers acknowledged that blinding of patients or healthcare professionals was not possible, a common limitation in studies for medical devices.
“The patch can contribute to safely achieving glycemic control for people initiating basal-bolus insulin therapy. It can potentially reduce patient and provider resistance to initiating mealtime insulin therapy and improve patient adherence and persistence, resulting in improved glycemic control over time,” concluded the researchers.
The study was funded by Calibra Medical, which was involved with all stages of the research and article preparation.
Bergenstal RM, Peyrot M, Dreon DM, et al. Implementation of basal–bolus therapyin type 2 diabetes: a randomized controlled trial comparing bolus insulin delivery using an insulin patch with an insulin pen. Diabetes Technol Ther. 2019;21(5):273-285.