Sue Brown1,2, Dan Raghinaru3, Emma Emory1, Boris Kovatchev4. 1. Center for Diabetes Technology, University of Virginia, Charlottesville, VA. 2. Division of Endocrinology and Metabolism, University of Virginia, Charlottesville, VA. 3. Jaeb Center for Health Research, Tampa, FL. 4. Center for Diabetes Technology, University of Virginia, Charlottesville, VA boris@virginia.edu.
Abstract
OBJECTIVE: To pilot test a new closed-loop control technology to validate it for a further large clinical trial. RESEARCH DESIGN AND METHODS: The t:slim X2 insulin pump with Control-IQ Technology (Tandem Diabetes Care) includes a Dexcom G6 sensor and a closed-loop algorithm implemented in the pump that 1) automates insulin correction boluses, 2) has a dedicated hypoglycemia safety system, and 3) gradually intensifies control overnight, aiming for blood glucose levels of approximately 100-120 mg/dL every morning. RESULTS: Five patients with type 1 diabetes (mean age 52.8 years, 2/3 male/female, mean A1C 6.5%) used Control-IQ in an outpatient setting (hotel) for approximately 37 h. During the closed loop, mean glucose was 129 mg/dL (135/121 mg/dL during the day/night), time within target range 70-180 mg/dL was 87% (82%/94% during the day/night), and time <60 mg/dL was 1.1% (2.0%/0.0% during the day/night). CONCLUSIONS: Following this pilot trial, Control-IQ was deployed in several studies, including the large-scale National Institutes of Health International Diabetes Closed-Loop (iDCL) Trial.
OBJECTIVE: To pilot test a new closed-loop control technology to validate it for a further large clinical trial. RESEARCH DESIGN AND METHODS: The t:slim X2 insulin pump with Control-IQ Technology (Tandem Diabetes Care) includes a Dexcom G6 sensor and a closed-loop algorithm implemented in the pump that 1) automates insulin correction boluses, 2) has a dedicated hypoglycemia safety system, and 3) gradually intensifies control overnight, aiming for blood glucose levels of approximately 100-120 mg/dL every morning. RESULTS: Five patients with type 1 diabetes (mean age 52.8 years, 2/3 male/female, mean A1C 6.5%) used Control-IQ in an outpatient setting (hotel) for approximately 37 h. During the closed loop, mean glucose was 129 mg/dL (135/121 mg/dL during the day/night), time within target range 70-180 mg/dL was 87% (82%/94% during the day/night), and time <60 mg/dL was 1.1% (2.0%/0.0% during the day/night). CONCLUSIONS: Following this pilot trial, Control-IQ was deployed in several studies, including the large-scale National Institutes of Health International Diabetes Closed-Loop (iDCL) Trial.
Authors: Stacey M Anderson; Dan Raghinaru; Jordan E Pinsker; Federico Boscari; Eric Renard; Bruce A Buckingham; Revital Nimri; Francis J Doyle; Sue A Brown; Patrick Keith-Hynes; Marc D Breton; Daniel Chernavvsky; Wendy C Bevier; Paige K Bradley; Daniela Bruttomesso; Simone Del Favero; Roberta Calore; Claudio Cobelli; Angelo Avogaro; Anne Farret; Jerome Place; Trang T Ly; Satya Shanmugham; Moshe Phillip; Eyal Dassau; Isuru S Dasanayake; Craig Kollman; John W Lum; Roy W Beck; Boris Kovatchev Journal: Diabetes Care Date: 2016-04-13 Impact factor: 19.112
Authors: Boris P Kovatchev; Eric Renard; Claudio Cobelli; Howard C Zisser; Patrick Keith-Hynes; Stacey M Anderson; Sue A Brown; Daniel R Chernavvsky; Marc D Breton; Anne Farret; Marie-Josée Pelletier; Jérôme Place; Daniela Bruttomesso; Simone Del Favero; Roberto Visentin; Alessio Filippi; Rachele Scotton; Angelo Avogaro; Francis J Doyle Journal: Diabetes Care Date: 2013-07 Impact factor: 19.112
Authors: Boris P Kovatchev; Eric Renard; Claudio Cobelli; Howard C Zisser; Patrick Keith-Hynes; Stacey M Anderson; Sue A Brown; Daniel R Chernavvsky; Marc D Breton; Lloyd B Mize; Anne Farret; Jérôme Place; Daniela Bruttomesso; Simone Del Favero; Federico Boscari; Silvia Galasso; Angelo Avogaro; Lalo Magni; Federico Di Palma; Chiara Toffanin; Mirko Messori; Eyal Dassau; Francis J Doyle Journal: Diabetes Care Date: 2014-06-14 Impact factor: 19.112
Authors: Martin Tauschmann; Janet M Allen; Malgorzata E Wilinska; Hood Thabit; Zoë Stewart; Peiyao Cheng; Craig Kollman; Carlo L Acerini; David B Dunger; Roman Hovorka Journal: Diabetes Care Date: 2016-01-06 Impact factor: 19.112
Authors: Claudio Cobelli; Eric Renard; Boris P Kovatchev; Patrick Keith-Hynes; Najib Ben Brahim; Jérôme Place; Simone Del Favero; Marc Breton; Anne Farret; Daniela Bruttomesso; Eyal Dassau; Howard Zisser; Francis J Doyle; Stephen D Patek; Angelo Avogaro Journal: Diabetes Care Date: 2012-09 Impact factor: 19.112
Authors: Thomas Danne; Revital Nimri; Tadej Battelino; Richard M Bergenstal; Kelly L Close; J Hans DeVries; Satish Garg; Lutz Heinemann; Irl Hirsch; Stephanie A Amiel; Roy Beck; Emanuele Bosi; Bruce Buckingham; Claudio Cobelli; Eyal Dassau; Francis J Doyle; Simon Heller; Roman Hovorka; Weiping Jia; Tim Jones; Olga Kordonouri; Boris Kovatchev; Aaron Kowalski; Lori Laffel; David Maahs; Helen R Murphy; Kirsten Nørgaard; Christopher G Parkin; Eric Renard; Banshi Saboo; Mauro Scharf; William V Tamborlane; Stuart A Weinzimer; Moshe Phillip Journal: Diabetes Care Date: 2017-12 Impact factor: 19.112
Authors: Sue A Brown; Boris P Kovatchev; Dan Raghinaru; John W Lum; Bruce A Buckingham; Yogish C Kudva; Lori M Laffel; Carol J Levy; Jordan E Pinsker; R Paul Wadwa; Eyal Dassau; Francis J Doyle; Stacey M Anderson; Mei Mei Church; Vikash Dadlani; Laya Ekhlaspour; Gregory P Forlenza; Elvira Isganaitis; David W Lam; Craig Kollman; Roy W Beck Journal: N Engl J Med Date: 2019-10-16 Impact factor: 91.245
Authors: Gregory P Forlenza; Laya Ekhlaspour; Marc Breton; David M Maahs; R Paul Wadwa; Mark DeBoer; Laurel H Messer; Marissa Town; Jennifer Pinnata; Geoff Kruse; Bruce A Buckingham; Daniel Cherñavvsky Journal: Diabetes Technol Ther Date: 2019-03-19 Impact factor: 6.118
Authors: Sue A Brown; Roy W Beck; Dan Raghinaru; Bruce A Buckingham; Lori M Laffel; R Paul Wadwa; Yogish C Kudva; Carol J Levy; Jordan E Pinsker; Eyal Dassau; Francis J Doyle; Louise Ambler-Osborn; Stacey M Anderson; Mei Mei Church; Laya Ekhlaspour; Gregory P Forlenza; Camilla Levister; Vinaya Simha; Marc D Breton; Craig Kollman; John W Lum; Boris P Kovatchev Journal: Diabetes Care Date: 2020-05-29 Impact factor: 19.112
Authors: Boris P Kovatchev; Laura Kollar; Stacey M Anderson; Charlotte Barnett; Marc D Breton; Kelly Carr; Rachel Gildersleeve; Mary C Oliveri; Christian A Wakeman; Sue A Brown Journal: Lancet Digit Health Date: 2020-01-03