{"id":12843,"date":"2025-08-27T14:20:45","date_gmt":"2025-08-27T14:20:45","guid":{"rendered":"https:\/\/www.dcberne.com\/?p=12843"},"modified":"2026-03-11T22:42:55","modified_gmt":"2026-03-11T22:42:55","slug":"from-concept-to-fda-clearance-the-journey-of-the-t1d1-app","status":"publish","type":"post","link":"https:\/\/www.dcberne.com\/en\/from-concept-to-fda-clearance-the-journey-of-the-t1d1-app\/","title":{"rendered":"From Concept to FDA Clearance \u2013 The Journey of the T1D1 App"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;1px||0px||false|false&#8221; custom_margin_tablet=&#8221;1px||0px||false|false&#8221; custom_margin_phone=&#8221;3px||||false|false&#8221; custom_margin_last_edited=&#8221;on|phone&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; border_width_top=&#8221;0.5px&#8221; border_color_top=&#8221;#505358&#8243; border_width_bottom=&#8221;0.5px&#8221; 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_module_preset=&#8221;default&#8221; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_post_title title=&#8221;off&#8221; author=&#8221;off&#8221; date=&#8221;off&#8221; comments=&#8221;off&#8221; featured_image=&#8221;off&#8221; module_id=&#8221;meta-new&#8221; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; title_font=&#8221;Avant Regular||||||||&#8221; title_text_color=&#8221;#000000&#8243; title_font_size=&#8221;64px&#8221; title_line_height=&#8221;70px&#8221; meta_font=&#8221;Calibri Regular||||||||&#8221; meta_text_color=&#8221;RGBA(255,255,255,0)&#8221; meta_font_size=&#8221;10px&#8221; meta_line_height=&#8221;16px&#8221; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#8221;0px||20px||false|false&#8221; custom_css_post_meta=&#8221;text-transform: uppercase;&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_post_title][et_pb_post_title author=&#8221;off&#8221; date_format=&#8221;j \u00b7 M \u00b7 Y&#8221; comments=&#8221;off&#8221; featured_image=&#8221;off&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; title_font=&#8221;Avant Regular||||||||&#8221; title_text_color=&#8221;#000000&#8243; title_font_size=&#8221;64px&#8221; title_line_height=&#8221;70px&#8221; meta_font=&#8221;Avant Regular||||||||&#8221; meta_text_color=&#8221;#000000&#8243; meta_font_size=&#8221;14px&#8221; meta_line_height=&#8221;24px&#8221; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#8221;0px||16px||false|false&#8221; title_font_size_tablet=&#8221;&#8221; title_font_size_phone=&#8221;42px&#8221; title_font_size_last_edited=&#8221;on|phone&#8221; title_line_height_tablet=&#8221;&#8221; title_line_height_phone=&#8221;48px&#8221; title_line_height_last_edited=&#8221;on|phone&#8221; custom_css_post_meta=&#8221;text-transform: uppercase;&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_post_title][et_pb_text _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Avant Regular||||||||&#8221; text_text_color=&#8221;#000000&#8243; text_font_size=&#8221;20px&#8221; text_line_height=&#8221;24px&#8221; link_text_color=&#8221;#89BBE5&#8243; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"font-weight: 400;\">At the 2022 DCB Innovation Challenge, 15-year-old Drew Mendelow shared his remarkable story.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; custom_padding_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#8221;0px||40px||false|false&#8221; 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link_text_color=&#8221;#89BBE5&#8243; custom_margin=&#8221;0px||94px||false|false&#8221; custom_margin_tablet=&#8221;0px||80px||false|false&#8221; custom_margin_phone=&#8221;||48px||false|false&#8221; custom_margin_last_edited=&#8221;on|phone&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>Diagnosed with Type 1 Diabetes at age 13, Drew experienced first-hand the lack of an app that could support his needs during his hospital stay. Instead of waiting for a solution, he decided to create one himself. Within only a few months after its launch in the App Store, his app had already been downloaded more than 45,000 times.<\/p>\n<p>However, because it did not meet the requirements for medical devices, the app had to be removed until FDA clearance could be obtained.<\/p>\n<p>This is where Diabetes Center Berne (DCB) became involved. Together with Drew and his family, and in collaboration with Comerge AG (Zurich), we worked to rebuild and document the app according to regulatory standards. The joint effort of the Mendelow family, Comerge, and our team led to the successful preparation and submission for FDA review.<\/p>\n<p>Almost three years later, the outcome is extraordinary: Drew has received FDA clearance for his T1D1 App. This achievement marks a historic milestone \u2013 the first regulated, over-the-counter insulin calculator medical device, with the youngest inventor ever to be part of such an approval.<\/p>\n<p>At DCB, we are proud to have supported this journey from initial idea to official approval. It is an example of how we foster innovation, empower inventors, and help accelerate solutions that directly improve lives.<br \/>This is not only Drew\u2019s success \u2013 it is also a model for how innovation in diabetes technology can thrive when supported by the right ecosystem. Drew\u2019s journey demonstrates that impactful solutions can emerge directly from the community of people living with diabetes, and that with the right support, innovation truly has the power to change lives.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/www.dcberne.com\/wp-content\/uploads\/2025\/08\/T1D1-app.png&#8221; title_text=&#8221;T1D1 app&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;#FAFAFA&#8221; custom_margin=&#8221;0px||120px||false|false&#8221; custom_margin_tablet=&#8221;0px||120px||false|false&#8221; 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custom_padding_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>More recent news<\/p>\n<p>[\/et_pb_text][et_pb_blog fullwidth=&#8221;off&#8221; posts_number=&#8221;3&#8243; include_categories=&#8221;33,34,35&#8243; meta_date=&#8221;j \u00b7 M \u00b7 Y&#8221; excerpt_length=&#8221;120&#8243; show_author=&#8221;off&#8221; show_pagination=&#8221;off&#8221; masonry_tile_background_color=&#8221;RGBA(255,255,255,0)&#8221; module_class=&#8221;dcb-news&#8221; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; header_font=&#8221;Avant Regular||||||||&#8221; header_text_color=&#8221;#000000&#8243; header_font_size=&#8221;20px&#8221; header_line_height=&#8221;24px&#8221; body_font=&#8221;Calibri Regular||||||||&#8221; body_text_color=&#8221;#505358&#8243; body_font_size=&#8221;16px&#8221; body_line_height=&#8221;22px&#8221; meta_font=&#8221;Calibri Regular||||||||&#8221; meta_font_size=&#8221;10px&#8221; meta_line_height=&#8221;16px&#8221; pagination_text_color=&#8221;#89BBE5&#8243; pagination_font_size=&#8221;18px&#8221; pagination_line_height=&#8221;24px&#8221; custom_margin=&#8221;0px|0px|0px|0px|false|false&#8221; custom_padding=&#8221;0px|0px|0px|0px|false|false&#8221; meta_line_height_tablet=&#8221;16px&#8221; meta_line_height_phone=&#8221;16px&#8221; meta_line_height_last_edited=&#8221;on|phone&#8221; custom_css_title=&#8221;margin-bottom: 8px !important;&#8221; custom_css_post_meta=&#8221;text-transform: uppercase;&#8221; border_width_all=&#8221;0px&#8221; global_colors_info=&#8221;{}&#8221; header_text_color__hover_enabled=&#8221;on|hover&#8221; header_text_color__hover=&#8221;#89BBE5&#8243; custom_css_featured_image_last_edited=&#8221;off|phone&#8221; custom_css_title_last_edited=&#8221;off|phone&#8221; custom_css_title_tablet=&#8221;margin-bottom: 8px;&#8221; custom_css_title_phone=&#8221;margin-bottom: 16px;&#8221; custom_css_content_last_edited=&#8221;on|phone&#8221; custom_css_content_phone=&#8221;margin-bottom: 24px;&#8221; custom_css_post_meta_last_edited=&#8221;on|phone&#8221; 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