[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-0-en-105":3,"doc-seo-456236-105":59,"doc-detail-456236-en":130},{"code":4,"msg":5,"data":6},0,"success",[7,13,18,23,28,33,38,43,48,51,55],{"id":8,"doc_module":4,"doc_module_name":9,"category_name":10,"show_sort_weight":11,"slug":12},1,"Document","Story & Novel",90,"story-novel",{"id":14,"doc_module":4,"doc_module_name":9,"category_name":15,"show_sort_weight":16,"slug":17},2,"Literature",80,"literature",{"id":19,"doc_module":4,"doc_module_name":9,"category_name":20,"show_sort_weight":21,"slug":22},4,"Exam",70,"exam",{"id":24,"doc_module":4,"doc_module_name":9,"category_name":25,"show_sort_weight":26,"slug":27},5,"Comic",60,"comic",{"id":29,"doc_module":4,"doc_module_name":9,"category_name":30,"show_sort_weight":31,"slug":32},6,"Technology",50,"technology",{"id":34,"doc_module":4,"doc_module_name":9,"category_name":35,"show_sort_weight":36,"slug":37},7,"Healthcare",40,"healthcare",{"id":39,"doc_module":4,"doc_module_name":9,"category_name":40,"show_sort_weight":41,"slug":42},8,"Research & Report",30,"research-report",{"id":44,"doc_module":4,"doc_module_name":9,"category_name":45,"show_sort_weight":46,"slug":47},9,"Religion & Spirituality",20,"religion-spirituality",{"id":46,"doc_module":4,"doc_module_name":9,"category_name":49,"show_sort_weight":46,"slug":50},"World Cup","world-cup",{"id":52,"doc_module":4,"doc_module_name":9,"category_name":53,"show_sort_weight":52,"slug":54},10,"Lifestyle","lifestyle",{"id":56,"doc_module":4,"doc_module_name":9,"category_name":57,"show_sort_weight":24,"slug":58},19,"General","general",{"code":4,"msg":60,"data":61},"ok",{"site_id":62,"language":63,"slug":64,"title":65,"keywords":66,"description":67,"schema_data":68,"social_meta":123,"head_meta":125,"extra_data":127,"updated_unix":129},105,"en","double-dummy-design-for-blinding-studies-with-automated-insulin-delivery-systems-a-proof-of-concept-trial","Double Dummy Design for Blinding Studies With Automated Insulin Delivery Systems - A Proof of Concept Trial","","Comparative assessment of therapeutic technologies is vulnerable to bias when interventions cannot be blinded, particularly when they differ in form or dosing and may influence patient preferences or investigator expectations. Double-dummy designs are established for drugs but remain difficult to apply to medical devices that require user interaction, such as automated insulin delivery (AID) systems linked to continuous glucose monitoring. This proof-of-concept trial details a double-dummy, blinded randomized methodology for two AID systems and demonstrates feasibility for comparing glycemic control without operator bias.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/double-dummy-design-for-blinding-studies-with-automated-insulin-delivery-systems-a-proof-of-concept-trial/456236/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/double-dummy-design-for-blinding-studies-with-automated-insulin-delivery-systems-a-proof-of-concept-trial/456236.png","ImageObject",300,407,{"name":92,"@type":93},"Franzy","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-29","2026-09-30",true,{"@type":102,"interactionType":103,"userInteractionCount":24},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"Why is blinding challenging in automated insulin delivery device trials?","Question",{"text":112,"@type":113},"AID systems are reactive to continuous glucose measurements and depend on user interactions. Creating placebo devices that blind both participants and investigators without compromising safety or integrity is difficult, especially when systems use different sensors.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"What does the double-dummy design involve in this trial?",{"text":117,"@type":113},"Participants receive both an active AID system and a matched control (diluent) to preserve blinding. Two AID systems are used so that insulin delivery and placebo-like delivery occur in a blinded, randomized manner.",{"name":119,"@type":110,"acceptedAnswer":120},"How was the trial structured into phases?",{"text":121,"@type":113},"The study used three phases: a 5-week run-in period, then two 6-day protected home environment phases separated by a 2-week washout. During run-in, participants were familiarized with Control-IQ and later switched to MM780G for comparison of the unblinded period.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},456236,1791493161,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":24,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":29,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":144,"preview_page_count":4},2336478945519,"https://ap-avatar.wpscdn.com/davatar_085a072bc5b1113ac321206ff7593b45","Double Dummy Design for Blinding Studies With Automated Insulin Delivery Systems: A Proof of Concept Trial  \nJournal of Diabetes Science and Technology 1–6  \n© 2026 Diabetes Technology Society  \nArticle reuse guidelines: [sagepub.com/journals-permissions](sagepub.com/journals-permissions)[ ](sagepub.com/journals-permissions)[DOI: 10.1177/19322968251409820](DOI: 10.1177/19322968251409820)[ ](DOI: 10.1177/19322968251409820)[journals.sagepub.com/home/dst](journals.sagepub.com/home/dst)  \nAmir Tirosh, MD, PhD 1,2, Andrea Benedetti, MEng3,  \nNama Peltz-Sinvani, MD 1, Maya Laron-Hirsh, RD 1, Yael Cohen, MBA 1, Amna Jabarin, MD 1, Benny Grosman, PhD3, and  \nOhad Cohen, MD, MBA 1,2,3  \nAbstract  \nBackground: 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.  \nMethods: 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.  \nOutcomes and conclusion: The study demonstrates the feasibility, of comparing 2 AID systems, without operartor bias.  \nKeywords  \nautomated insulin delivery systems, double dummy, comparative study, continuous glucose monitoring (CGM)  \nComparative assessment of technologies used for therapeutics are fraught with challenges primarily due to the inability of the therapies to be blinded. This introduces biases due to the preferences, sponsorships, either intentional or subliminal. In pharmacological studies, this has been addressed with the introduction of the double dummy study design, 1 when the comparator interventions are of different nature (eg, tablets vs injectables) or dosing intervals (eg, daily vs weekly injections) . In these studies, identical placebos with similar physical appearances, but without the active component are used as controls, to each of the interventions (eg, tablets and injections) . Participants are then randomized in a blinded way to the 2 components assessed, one that consists of the active component and the other one a control. The study design can thereafter include a crossover stage. This design is limited when regards to medical devices, where repeated interactions with the device are required for achieving outcomes. Automated insulin delivery (AID) systems are a notable example as these devices are reactive to continuous glucose measurement aimed to achieved glycemic control which is affected by user interactions. In addition, not all AID systems are driven by similar sensors, and no continuous glucose monitoring (CGM) system to date can be linked to more than one system. Therefore, it is difficult to create  \nplacebo devices that can effectively blind both participants and investigators without compromising the study’s integrity or the participants’ safety. To the best of our knowledge, no studies have been published to date, comparing insulin delivery systems utilizing a double-dummy design to address user and investigator biases.  \nIn this report we describe the methodology and outcomes of a feasibility proof of concept double-dummy blinded randomized trial comparing 2 different AID systems.  \nStudy was registered within the Israeli Ministry of Health number MOH_2023-04-09_012516.  \nAim: The purpose of this study was to assess the feasibility to compare glycemic control of 2 AID systems in adult subjects with type 1 diabetes in a blinded manner.  \n1 Division of Endocrinology, Diabetes and Metabolism, Sheba Medical Center, Tel-Hashomer, Israel  \n2Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel 3Medtronic, Northridge, CA, USA  \nCorresponding Author: ","cbCaiivDQiRQyGYf","https://ap.wps.com/l/cbCaiivDQiRQyGYf","pdf",760622,"English","# Abstract\n## Background\n## Methods\n## Outcomes and conclusion\n# Study Design and Aim\n## Registration\n## Objective\n# Trial Methods\n## Devices and nomenclature\n## Phases and run-in\n## Randomization\n# Protected Home Phase","[{\"question\":\"Why is blinding challenging in automated insulin delivery device trials?\",\"answer\":\"AID systems are reactive to continuous glucose measurements and depend on user interactions. Creating placebo devices that blind both participants and investigators without compromising safety or integrity is difficult, especially when systems use different sensors.\"},{\"question\":\"What does the double-dummy design involve in this trial?\",\"answer\":\"Participants receive both an active AID system and a matched control (diluent) to preserve blinding. Two AID systems are used so that insulin delivery and placebo-like delivery occur in a blinded, randomized manner.\"},{\"question\":\"How was the trial structured into phases?\",\"answer\":\"The study used three phases: a 5-week run-in period, then two 6-day protected home environment phases separated by a 2-week washout. During run-in, participants were familiarized with Control-IQ and later switched to MM780G for comparison of the unblinded period.\"}]","Double Dummy Design for Blinding Studies With Automated Insulin Delivery Systems - A Proof of Concept Trial | PDF",1790745396,15]