1038-P: Results of Interim Analysis of a Randomized Crossover Study in Type 1 Diabetes (T1D) of a Dual-Hormone Closed-Loop System with Xerisol™ Glucagon vs. Insulin-Only Closed-Loop System vs. a Predictive Low Glucose Suspend System

Dual-hormone systems show promise to reduce hypoglycemia, but require a stable liquid glucagon formulation. XeriSol™ glucagon is a shelf-stable glucagon product for this use. Nineteen subjects with T1D are completing a single-center three-day outpatient study comparing control modes of the Oregon Ar...

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Veröffentlicht in:	Diabetes (New York, N.Y.) N.Y.), 2019-06, Vol.68 (Supplement_1)
Hauptverfasser:	WILSON, LEAH M., JACOBS, PETER G., RESALAT, NAVID, REDDY, RAVI, YOUSSEF, JOSEPH EL, BRANIGAN, DEBORAH, LEITSCHUH, JOSEPH A., SENF, BRIAN, GABO, VIRGINIA, CASTLE, JESSICA R.
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Sprache:	eng
Schlagworte:	Closed loop systems Diabetes Diabetes mellitus Diabetes mellitus (insulin dependent) Dosage Exercise Glucagon Hypoglycemia Insulin Pancreas
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creator	WILSON, LEAH M. JACOBS, PETER G. RESALAT, NAVID REDDY, RAVI YOUSSEF, JOSEPH EL BRANIGAN, DEBORAH LEITSCHUH, JOSEPH A. SENF, BRIAN GABO, VIRGINIA CASTLE, JESSICA R.
description	Dual-hormone systems show promise to reduce hypoglycemia, but require a stable liquid glucagon formulation. XeriSol™ glucagon is a shelf-stable glucagon product for this use. Nineteen subjects with T1D are completing a single-center three-day outpatient study comparing control modes of the Oregon Artificial Pancreas system: 1) dual hormone (DH) closed-loop with Novolog™ insulin and XeriSol™ glucagon, 2) insulin-only single hormone (SH) closed-loop, 3) insulin-only predictive low glucose suspend system (PLGS). In clinic aerobic exercise (45 minutes at 60% VO2max) and home exercise was completed with each arm. SH and DH used automated exercise detection to adaptively dose insulin/glucagon for predicted hypoglycemia and tailored mealtime dosing based on past meal responses with an adaptive algorithm. An interim analysis after 7 subjects was completed for safety. The primary outcome measures are % time 70-180 mg/dL and % time
doi_str_mv	10.2337/db19-1038-P
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XeriSol™ glucagon is a shelf-stable glucagon product for this use. Nineteen subjects with T1D are completing a single-center three-day outpatient study comparing control modes of the Oregon Artificial Pancreas system: 1) dual hormone (DH) closed-loop with Novolog™ insulin and XeriSol™ glucagon, 2) insulin-only single hormone (SH) closed-loop, 3) insulin-only predictive low glucose suspend system (PLGS). In clinic aerobic exercise (45 minutes at 60% VO2max) and home exercise was completed with each arm. SH and DH used automated exercise detection to adaptively dose insulin/glucagon for predicted hypoglycemia and tailored mealtime dosing based on past meal responses with an adaptive algorithm. An interim analysis after 7 subjects was completed for safety. The primary outcome measures are % time 70-180 mg/dL and % time <70 mg/dL for the 3-day study and the 4-hour period from start of exercise until the next meal. From start of exercise until the next meal, DH showed a clinically meaningful reduction of time in hypoglycemia compared with PLGS and SH. For the entire study, DH showed a clinically meaningful lower time <70mg/dL. 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From start of exercise until the next meal, DH showed a clinically meaningful reduction of time in hypoglycemia compared with PLGS and SH. For the entire study, DH showed a clinically meaningful lower time <70mg/dL. No serious events or unexpected side effects occurred.</description><subject>Closed loop systems</subject><subject>Diabetes</subject><subject>Diabetes mellitus</subject><subject>Diabetes mellitus (insulin dependent)</subject><subject>Dosage</subject><subject>Exercise</subject><subject>Glucagon</subject><subject>Hypoglycemia</subject><subject>Insulin</subject><subject>Pancreas</subject><issn>0012-1797</issn><issn>1939-327X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><recordid>eNptkc1u00AQx1cIJELhxAuMxAVUbdkPJ-vlViX0Q4rUqAlSb9baHsNWzq7ZtVOZc5-ER-PIU7BuekRzGM3oNx_6_wl5z9mZkFJ9rkuuKWcyp5sXZMa11FQKdfeSzBjjgnKl1WvyJsZ7xtgixYz8PdJf4Bbj0PYRfAPXrsdg93DuTDtG-9QzcGtc7ff2F9awDD5Gf8AA236oR7AOdmOHwGFlTYk9Rvi446tPx8HVYFp65cPeO4Rl6yPWdO19B9sx9riHB9v_gLt0Mfr2z-NvuGyHynz3Dg7xLP2S3rKO3rh2_N_wxBjYBKxt1dsDwto_PG1IJGyH2KGrn9m35FVj2ojvnvMJ-Xbxdbe8ouuby-vl-ZpWnC3m1IhKL1QudC5ULnkpUOVK1UznTckaXplM66ZBFFjxLJtrw1gmSpaKCedGnpAPx71d8D8HjH1x74eQtIyFEFkutZ7n80SdHqlqEjNgU3RJcxPGgrNiMrOYzCwme4qN_AfJAZOQ</recordid><startdate>20190601</startdate><enddate>20190601</enddate><creator>WILSON, LEAH M.</creator><creator>JACOBS, PETER G.</creator><creator>RESALAT, NAVID</creator><creator>REDDY, RAVI</creator><creator>YOUSSEF, JOSEPH EL</creator><creator>BRANIGAN, DEBORAH</creator><creator>LEITSCHUH, JOSEPH A.</creator><creator>SENF, BRIAN</creator><creator>GABO, VIRGINIA</creator><creator>CASTLE, JESSICA R.</creator><general>American Diabetes Association</general><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>NAPCQ</scope></search><sort><creationdate>20190601</creationdate><title>1038-P: Results of Interim Analysis of a Randomized Crossover Study in Type 1 Diabetes (T1D) of a Dual-Hormone Closed-Loop System with Xerisol™ Glucagon vs. Insulin-Only Closed-Loop System vs. a Predictive Low Glucose Suspend System</title><author>WILSON, LEAH M. ; JACOBS, PETER G. ; RESALAT, NAVID ; REDDY, RAVI ; YOUSSEF, JOSEPH EL ; BRANIGAN, DEBORAH ; LEITSCHUH, JOSEPH A. ; SENF, BRIAN ; GABO, VIRGINIA ; CASTLE, JESSICA R.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c1065-a2c967829827831b2e7877d098fb0f1ca499ffee2ec14459a0042b0c1478311a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Closed loop systems</topic><topic>Diabetes</topic><topic>Diabetes mellitus</topic><topic>Diabetes mellitus (insulin dependent)</topic><topic>Dosage</topic><topic>Exercise</topic><topic>Glucagon</topic><topic>Hypoglycemia</topic><topic>Insulin</topic><topic>Pancreas</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>WILSON, LEAH M.</creatorcontrib><creatorcontrib>JACOBS, PETER G.</creatorcontrib><creatorcontrib>RESALAT, NAVID</creatorcontrib><creatorcontrib>REDDY, RAVI</creatorcontrib><creatorcontrib>YOUSSEF, JOSEPH EL</creatorcontrib><creatorcontrib>BRANIGAN, DEBORAH</creatorcontrib><creatorcontrib>LEITSCHUH, JOSEPH A.</creatorcontrib><creatorcontrib>SENF, BRIAN</creatorcontrib><creatorcontrib>GABO, VIRGINIA</creatorcontrib><creatorcontrib>CASTLE, JESSICA R.</creatorcontrib><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><jtitle>Diabetes (New York, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>WILSON, LEAH M.</au><au>JACOBS, PETER G.</au><au>RESALAT, NAVID</au><au>REDDY, RAVI</au><au>YOUSSEF, JOSEPH EL</au><au>BRANIGAN, DEBORAH</au><au>LEITSCHUH, JOSEPH A.</au><au>SENF, BRIAN</au><au>GABO, VIRGINIA</au><au>CASTLE, JESSICA R.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>1038-P: Results of Interim Analysis of a Randomized Crossover Study in Type 1 Diabetes (T1D) of a Dual-Hormone Closed-Loop System with Xerisol™ Glucagon vs. Insulin-Only Closed-Loop System vs. a Predictive Low Glucose Suspend System</atitle><jtitle>Diabetes (New York, N.Y.)</jtitle><date>2019-06-01</date><risdate>2019</risdate><volume>68</volume><issue>Supplement_1</issue><issn>0012-1797</issn><eissn>1939-327X</eissn><abstract>Dual-hormone systems show promise to reduce hypoglycemia, but require a stable liquid glucagon formulation. XeriSol™ glucagon is a shelf-stable glucagon product for this use. Nineteen subjects with T1D are completing a single-center three-day outpatient study comparing control modes of the Oregon Artificial Pancreas system: 1) dual hormone (DH) closed-loop with Novolog™ insulin and XeriSol™ glucagon, 2) insulin-only single hormone (SH) closed-loop, 3) insulin-only predictive low glucose suspend system (PLGS). In clinic aerobic exercise (45 minutes at 60% VO2max) and home exercise was completed with each arm. SH and DH used automated exercise detection to adaptively dose insulin/glucagon for predicted hypoglycemia and tailored mealtime dosing based on past meal responses with an adaptive algorithm. An interim analysis after 7 subjects was completed for safety. The primary outcome measures are % time 70-180 mg/dL and % time <70 mg/dL for the 3-day study and the 4-hour period from start of exercise until the next meal. From start of exercise until the next meal, DH showed a clinically meaningful reduction of time in hypoglycemia compared with PLGS and SH. For the entire study, DH showed a clinically meaningful lower time <70mg/dL. No serious events or unexpected side effects occurred.</abstract><cop>New York</cop><pub>American Diabetes Association</pub><doi>10.2337/db19-1038-P</doi></addata></record>
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subjects	Closed loop systems Diabetes Diabetes mellitus Diabetes mellitus (insulin dependent) Dosage Exercise Glucagon Hypoglycemia Insulin Pancreas
title	1038-P: Results of Interim Analysis of a Randomized Crossover Study in Type 1 Diabetes (T1D) of a Dual-Hormone Closed-Loop System with Xerisol™ Glucagon vs. Insulin-Only Closed-Loop System vs. a Predictive Low Glucose Suspend System
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