Double Dummy Design for Blinding Studies With Automated Insulin Delivery Systems: A Proof of Concept Trial.

ABSTRACT:

Background

Comparative assessment of therapeutic technologies is often biased due to the inability to blind interventions, especially when therapies differ in form or dosing. While double-dummy design, where participants receive both an active treatment and a matched placebo to maintain blinding, is well established in pharmacological trials, its applicability for medical devices requiring user interaction, such as automated insulin delivery (AID) systems is challenging.

Methods

We present the methodology by which two AID systems are used in a double-dummy, blinded, randomized trial, one system providing insulin therapy and the other, a diluent.Outcomes and conclusion:The study demonstrates the feasibility, of comparing 2 AID systems, without operartor bias.

SUBMITTER: Tirosh A 

PROVIDER: S-EPMC12779536 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature