Related Experiment Video
Updated: Jan 13, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Double Dummy Design for Blinding Studies With Automated Insulin Delivery Systems: A Proof of Concept Trial
Amir Tirosh1,2, Andrea Benedetti3, Nama Peltz-Sinvani1
1Division of Endocrinology, Diabetes and Metabolism, Sheba Medical Center, Tel-Hashomer, Israel.
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.
Related Concept Videos
Blinding
Blind Procedures
Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Insulin Formulations: Types and Delivery
Short-acting insulins are divided into...
Insulin: Dosing Regimen and Adverse Effects
The basal dose constitutes about 40%-50% of the total daily dose, with the rest as premeal insulin. The mealtime insulin dose should mirror...

