TY - JOUR
T1 - Double Dummy Design for Blinding Studies With Automated Insulin Delivery Systems
T2 - A Proof of Concept Trial
AU - Tirosh, Amir
AU - Benedetti, Andrea
AU - Peltz-Sinvani, Nama
AU - Laron-Hirsh, Maya
AU - Cohen, Yael
AU - Jabarin, Amna
AU - Grosman, Benny
AU - Cohen, Ohad
N1 - Publisher Copyright:
© 2026 Diabetes Technology Society. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).
PY - 2026/1/1
Y1 - 2026/1/1
N2 - 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.
AB - 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.
KW - automated insulin delivery systems
KW - comparative study
KW - continuous glucose monitoring (CGM)
KW - double dummy
UR - https://www.scopus.com/pages/publications/105026701269
U2 - 10.1177/19322968251409820
DO - 10.1177/19322968251409820
M3 - Article
AN - SCOPUS:105026701269
SN - 1932-2968
JO - Journal of Diabetes Science and Technology
JF - Journal of Diabetes Science and Technology
ER -