{"id":39,"date":"2014-07-08T19:17:26","date_gmt":"2014-07-08T23:17:26","guid":{"rendered":"https:\/\/sites.bu.edu\/bionicpancreas\/?page_id=39"},"modified":"2019-03-26T18:12:06","modified_gmt":"2019-03-26T22:12:06","slug":"clinical-trials","status":"publish","type":"page","link":"https:\/\/sites.bu.edu\/bionicpancreas\/clinical-trials\/","title":{"rendered":"Clinical Trials"},"content":{"rendered":"<h1>Outpatient and Home-Use Clinical Trials<\/h1>\n<div id=\"ct_canvas\">\n<div id=\"ct_panel_nn_fiasp\">\n<div class=\"ct_header\">\n<h2>iLet&trade; Multi-PK Profiling Study<\/h2>\n<\/div>\n<div class=\"ct_date\" style=\"font-size: 12px\">March 2019 &#8211; December 2019<\/div>\n<div id=\"ct_image_nn_fiasp\">\n         <img src=\"\/bionicpancreas\/files\/2019\/03\/G3.2_IO_Contact_Detach_small.png\" alt=\"The GEN3.2 iLet\" width=400\">\n      <\/div>\n<div id=\"ct_description_nn_fiasp\">\n<h3 style=\"text-align: center\">Three 7-day iLet experiments in adults with T1D<\/h3>\n<ul>\n<li>Up to 30 subjects, each participating in three 7-day randomized cross-over treatment arms<\/li>\n<li>One week with Humalog, one week with Novolog, and one week with BioChaperone&reg; Lispro (BC222)<\/li>\n<li>Must be &ge;18 years old and remain within 250 miles of study base with no air travel<\/li>\n<li>Home use study: People with T1D engaged in usual daily work and leisure routine<\/li>\n<li>Realtime telemetric monitoring for hypoglycemia and hyperglycemia<\/li>\n<\/ul><\/div>\n<p><\/p>\n<div id=\"ct_enrollment_nn_fiasp\">\n<p>Please visit our <a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03262116?term=Steven+Russell&#038;rank=2\" target=\"_blank\">clinicaltrials.gov study record<\/a>.<\/p>\n<p><\/p>\n<p>(not yet recruiting)<\/p>\n<p>\n      <\/div>\n<\/p><\/div>\n<div id=\"ct_panel_nn_fiasp\">\n<div class=\"ct_header\">\n<h2>Fiasp&reg; with iLet&trade; PK Exploratory Study<\/h2>\n<\/div>\n<div class=\"ct_date\" style=\"font-size: 12px\">March 2019 &#8211; May 2019<\/div>\n<div id=\"ct_image_nn_fiasp\">\n         <img src=\"\/bionicpancreas\/files\/2019\/03\/G3.2_IO_Contact_Detach_small.png\" alt=\"The GEN3.2 iLet\" width=400\">\n      <\/div>\n<div id=\"ct_description_nn_fiasp\">\n<h3 style=\"text-align: center\">Two 7-day iLet experiments in adults with T1D<\/h3>\n<ul>\n<li>Three cohorts, eight subjects per cohort, with each subject participating in two randomized cross-over treatment arms<\/li>\n<li>Treatment arm 1: 7 days on the iLet with Fiasp using usual pharmacokinetic (PK) settings<\/li>\n<li>Treatment arm 2: 7 days on the iLet with Fiasp using exploratory PK settings<\/li>\n<li>Three days in a supervised study setting, 4 days in a home-use setting<\/li>\n<li>Must live within 120 minutes of study base<\/li>\n<li>Must have a screening A1c within 6.5-9%<\/li>\n<li>Realtime telemetric monitoring for hypoglycemia and hyperglycemia<\/li>\n<\/ul><\/div>\n<p><\/p>\n<div id=\"ct_enrollment_nn_fiasp\">\n<p>Please visit our <a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03816761\" target=\"_blank\">clinicaltrials.gov study record<\/a>.<\/p>\n<p><\/p>\n<p>(recruiting now)<\/p>\n<p>\n      <\/div>\n<\/p><\/div>\n<div id=\"ct_panel_mc\">\n<div class=\"ct_header\">\n<h2>The Bionic Pancreas Multi-Center Study<\/h2>\n<\/div>\n<div class=\"ct_date\" style=\"font-size: 12px\">June 2014 &#8211; April 2015<\/div>\n<div id=\"ct_image_mc\">\n         <img src=\"\/bionicpancreas\/files\/2014\/07\/MC_401x150.png\" alt=\"The Bionic Pancreas Multi-Center Study\">\n      <\/div>\n<div id=\"ct_description_mc\">\n<h3 style=\"text-align: center\">11-day experiments in adults with T1D<\/h3>\n<ul>\n<li>Randomized cross-over design (11 days on bionic pancreas, 11 days on usual care)<\/li>\n<li>Home use study: People with T1D engaged in usual daily work and leisure routine<\/li>\n<li>Must live within 30 minutes, stay within 60 minutes of study base<\/li>\n<li>Sleep at home (with a designated contact), technical &#038; medical support on call<\/li>\n<li>Telemetry to monitor wireless connectivity of pumps and CGM, and if the CGM reads < 50 mg\/dL<\/li>\n<li>40 adult subjects 18 years and older (440 bionic pancreas days)<\/li>\n<\/ul><\/div>\n<p><\/p>\n<div id=\"ct_enrollment_mc\">\n<p>Please visit our <a href=\"http:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT02092220?term=multicenter+study+russell&#038;rank=2\" target=\"_blank\">clinicaltrials.gov study record<\/a>.<\/p>\n<p><\/p>\n<p>(complete, no longer enrolling)<\/p>\n<p>\n      <\/div>\n<\/p><\/div>\n<div id=\"ct_panel_sc2\">\n<div class=\"ct_header\">\n<h2>2014 Summer Camp Study<\/h2>\n<\/div>\n<div class=\"ct_date\" style=\"font-size: 12px\">July 2014 &#8211; August 2014<\/div>\n<div id=\"ct_image_sc2\">\n         <img src=\"\/bionicpancreas\/files\/2014\/07\/SC2_400x418.png\" alt=\"2014 Summer Camp Study\">\n      <\/div>\n<div id=\"ct_description_sc2\">\n<h3 style=\"text-align: center\">5-day experiments in pre-adolescents with T1D<\/h3>\n<ul>\n<li>Randomized cross-over design (5 days on bionic pancreas, 5 days on insulin pump therapy)<\/li>\n<li>Integrated camp experience at Camp Joslin (boys) and Clara Barton Camp (girls)<\/li>\n<li>Point of care capillary BG checks during day and night<\/li>\n<li>Study staff and camp staff provide 24-hour coverage; round-the-clock telemetry to monitor wireless connectivity of pumps and CGM<\/li>\n<li>7 boys, 13 girls (6-11 years old) with T1D (120 bionic pancreas days)<\/li>\n<\/ul><\/div>\n<div id=\"ct_enrollment_sc2\">\n<p>Please visit our <a href=\"http:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT02105324?term=%22summer+camp%22&#038;rank=2\" target=\"_blank\">clinicaltrials.gov study record<\/a>.<\/p>\n<p><\/p>\n<p>(complete, no longer enrolling)<\/p>\n<p>\n      <\/div>\n<\/p><\/div>\n<div id=\"ct_panel_sc1\">\n<div class=\"ct_header\">\n<h2>2013 Summer Camp Study<\/h2>\n<\/div>\n<div class=\"ct_date\" style=\"font-size: 12px\">July 2013 &#8211; August 2013<\/div>\n<div id=\"ct_image_sc1\">\n         <img src=\"\/bionicpancreas\/files\/2014\/07\/SC1_400x225.png\" alt=\"2013 Summer Camp Study\">\n      <\/div>\n<div id=\"ct_description_sc1\">\n<h3 style=\"text-align: center\">5-day experiments in adolescents with T1D<\/h3>\n<ul>\n<li>Randomized cross-over design (5 days on bionic pancreas, 5 days on insulin pump therapy)<\/li>\n<li>Integrated camp experience at Camp Joslin (boys) and Clara Barton Camp (girls)<\/li>\n<li>Point of care capillary BG checks during day and night<\/li>\n<li>Study staff and camp staff provide 24-hour coverage; round-the-clock telemetry to monitor glycemia<\/li>\n<li>16 boys, 16 girls (12-20 years old) with T1D (160 bionic pancreas days)<\/li>\n<\/ul><\/div>\n<div id=\"ct_enrollment_sc1\">\n<p>Please visit our <a href=\"http:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT01833988?term=summer+camp+study&#038;rank=1\" target=\"_blank\">clinicaltrials.gov study record<\/a>.<br \/>(complete, no longer enrolling)<\/p>\n<\/p><\/div>\n<\/p><\/div>\n<div id=\"ct_panel_bhs\">\n<div class=\"ct_header\">\n<h2>The Beacon Hill Study<\/h2>\n<\/div>\n<div class=\"ct_date\" style=\"font-size: 12px\">February 2013 &#8211; September 2013<\/div>\n<div id=\"ct_image_bhs\">\n         <img src=\"\/bionicpancreas\/files\/2014\/07\/BHS_400x400.png\" alt=\"The Beacon Hill Study\">\n      <\/div>\n<div id=\"ct_description_bhs\">\n<h3 style=\"text-align: center\">5-day experiments in adults with T1D<\/h3>\n<ul>\n<li>Randomized cross-over design (5 days on bionic pancreas, 5 days usual care)<\/li>\n<li>Free run of Boston peninsula east of Mass Ave (three square mile area)<\/li>\n<li>Point of care capillary BG checks during day, 1:1 nursing<\/li>\n<li>Sleep in hotel with venous BG monitoring at night, 1:2 nursing<\/li>\n<li>20 adult subjects 21 years and older (100 bionic pancreas days)<\/li>\n<\/ul><\/div>\n<div id=\"ct_enrollment_bhs\">\n<p>Please visit our <a href=\"http:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT01762059?term=beacon+hill+study&#038;rank=1#main-content\" target=\"_blank\">clinicaltrials.gov study record<\/a>.<br \/>(complete, no longer enrolling)<\/p>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Outpatient and Home-Use Clinical Trials iLet&trade; Multi-PK Profiling Study March 2019 &#8211; December 2019 Two 7-day iLet experiments in adults with T1D Three cohorts, eight subjects per cohort, with each subject participating in two randomized cross-over treatment arms Treatment arm 1: 7 days on the iLet with Fiasp using usual pharmacokinetic (PK) settings Treatment arm [&hellip;]<\/p>\n","protected":false},"author":8928,"featured_media":0,"parent":0,"menu_order":4,"comment_status":"closed","ping_status":"closed","template":"page-templates\/no-sidebars.php","meta":[],"_links":{"self":[{"href":"https:\/\/sites.bu.edu\/bionicpancreas\/wp-json\/wp\/v2\/pages\/39"}],"collection":[{"href":"https:\/\/sites.bu.edu\/bionicpancreas\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sites.bu.edu\/bionicpancreas\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sites.bu.edu\/bionicpancreas\/wp-json\/wp\/v2\/users\/8928"}],"replies":[{"embeddable":true,"href":"https:\/\/sites.bu.edu\/bionicpancreas\/wp-json\/wp\/v2\/comments?post=39"}],"version-history":[{"count":50,"href":"https:\/\/sites.bu.edu\/bionicpancreas\/wp-json\/wp\/v2\/pages\/39\/revisions"}],"predecessor-version":[{"id":2639,"href":"https:\/\/sites.bu.edu\/bionicpancreas\/wp-json\/wp\/v2\/pages\/39\/revisions\/2639"}],"wp:attachment":[{"href":"https:\/\/sites.bu.edu\/bionicpancreas\/wp-json\/wp\/v2\/media?parent=39"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}