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

Amir Tirosh; Andrea Benedetti; Nama Peltz-Sinvani; Maya Laron-Hirsh; Yael Cohen; Amna Jabarin; Benny Grosman; Ohad Cohen

doi:10.1177/19322968251409820

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

Amir Tirosh
, Andrea Benedetti
, Nama Peltz-Sinvani
, Maya Laron-Hirsh
, Yael Cohen
, Amna Jabarin
, Benny Grosman
, Ohad Cohen

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Journal	Journal of Diabetes Science and Technology
DOIs	https://doi.org/10.1177/19322968251409820
State	Accepted/In press - 1 Jan 2026
Externally published	Yes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

automated insulin delivery systems
comparative study
continuous glucose monitoring (CGM)
double dummy

ASJC Scopus subject areas

Internal Medicine
Bioengineering
Endocrinology, Diabetes and Metabolism
Biomedical Engineering

Access to Document

10.1177/19322968251409820

Cite this

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title = "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.",

keywords = "automated insulin delivery systems, comparative study, continuous glucose monitoring (CGM), double dummy",

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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

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DO - 10.1177/19322968251409820

M3 - Article

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AN - SCOPUS:105026701269

SN - 1932-2968

JO - Journal of Diabetes Science and Technology

JF - Journal of Diabetes Science and Technology

ER -

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

Abstract

UN SDGs

Keywords

ASJC Scopus subject areas

Access to Document

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