PaQ®, a simple 3-day basal/bolus insulin delivery device, in people with type 2 diabetes

Abstract

Background: PaQ is a patch on device which provides set basal rates and bolus insulin on demand. This study assessed feasibility of use, method of transition, glycemic control, patientreported outcomes and safety in people with type 2 diabetes mellitus (T2DM) using PaQ. Design and methods: Twenty patients with T2DM on a stable multiple daily injection (MDI) insulin regimen with HbA1c (less-than or equal to)9% were enrolled in this single center, single arm evaluation. The study was comprised of three 2-week periods; baseline (MDI), transition and PaQ treatment. Feasibility endpoints included: ability to assemble, use and change PaQ. Transition was assessed by days required, number of basal rates and total daily dose of insulin (TDD) used. Efficacy assessments included: selfmonitored blood glucose and continuous glucose monitoring. Safety was assessed using: site examination, hypoglycemic episodes and adverse device effects (ADEs). Results: PaQ performed as expected. All patients were able to assemble and use PaQ without use errors leading to ADEs. All patients transitioned to PaQ with 73% using the first basal rate chosen. TDD used was same as baseline MDI. No severe hypoglycaemic event occurred during baseline or on PaQ. All patients were nullvery satisfiednull (83%) or nullsatisfiednull (17%) with the time it took to learn and administer bolus doses with PaQ. Conclusions: Preliminary data show patients with T2DM taking MDI were successfully transitioned, safely able to use and very satisfied with PaQ.