Boris Kovatchev1, Stacey M Anderson2, Dan Raghinaru3, Yogish C Kudva4, Lori M Laffel5, Carol Levy6, Jordan E Pinsker7, R Paul Wadwa8, Bruce Buckingham9, Francis J Doyle10, Sue A Brown2, Mei Mei Church7, Vikash Dadlani4, Eyal Dassau10, Laya Ekhlaspour9, Gregory P Forlenza8, Elvira Isganaitis5, David W Lam6, John Lum11, Roy W Beck. 1. Center for Diabetes Technology, University of Virginia, Charlottesville, VA. 2. Division of Endocrinology and Metabolism, Department of Medicine, University of Virginia, Charlottesville, VA. 3. Jaeb Center for Health Research, Tampa, FL. 4. Division of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN. 5. Joslin Diabetes Center, Harvard Medical School, Boston, MA. 6. Division of Endocrinology, Icahn School of Medicine at Mount Sinai, New York, NY. 7. Sansum Diabetes Research Institute, Santa Barbara, CA. 8. Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora, CO. 9. Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA. 10. Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA. 11. Jaeb Center for Health Research, Tampa, FL jl_manuscripts@jaeb.org.
Abstract
OBJECTIVE: Assess the efficacy of inControl AP, a mobile closed-loop control (CLC) system. RESEARCH DESIGN AND METHODS: This protocol, NCT02985866, is a 3-month parallel-group, multicenter, randomized unblinded trial designed to compare mobile CLC with sensor-augmented pump (SAP) therapy. Eligibility criteria were type 1 diabetes for at least 1 year, use of insulin pumps for at least 6 months, age ≥14 years, and baseline HbA1c <10.5% (91 mmol/mol). The study was designed to assess two coprimary outcomes: superiority of CLC over SAP in continuous glucose monitor (CGM)-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L. RESULTS:Between November 2017 and May 2018, 127 participants were randomly assigned 1:1 to CLC (n = 65) versus SAP (n = 62); 125 participants completed the study. CGM time below 3.9 mmol/L was 5.0% at baseline and 2.4% during follow-up in the CLC group vs. 4.7% and 4.0%, respectively, in the SAP group (mean difference -1.7% [95% CI -2.4, -1.0]; P < 0.0001 for superiority). CGM time above 10 mmol/L was 40% at baseline and 34% during follow-up in the CLC group vs. 43% and 39%, respectively, in the SAP group (mean difference -3.0% [95% CI -6.1, 0.1]; P < 0.0001 for noninferiority). One severe hypoglycemic event occurred in the CLC group, which was unrelated to the study device. CONCLUSIONS: In meeting its coprimary end points, superiority of CLC over SAP in CGM-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L, the study has demonstrated that mobile CLC is feasible and could offer certain usability advantages over embedded systems, provided the connectivity between system components is stable.
RCT Entities:
OBJECTIVE: Assess the efficacy of inControl AP, a mobile closed-loop control (CLC) system. RESEARCH DESIGN AND METHODS: This protocol, NCT02985866, is a 3-month parallel-group, multicenter, randomized unblinded trial designed to compare mobile CLC with sensor-augmented pump (SAP) therapy. Eligibility criteria were type 1 diabetes for at least 1 year, use of insulin pumps for at least 6 months, age ≥14 years, and baseline HbA1c <10.5% (91 mmol/mol). The study was designed to assess two coprimary outcomes: superiority of CLC over SAP in continuous glucose monitor (CGM)-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L. RESULTS: Between November 2017 and May 2018, 127 participants were randomly assigned 1:1 to CLC (n = 65) versus SAP (n = 62); 125 participants completed the study. CGM time below 3.9 mmol/L was 5.0% at baseline and 2.4% during follow-up in the CLC group vs. 4.7% and 4.0%, respectively, in the SAP group (mean difference -1.7% [95% CI -2.4, -1.0]; P < 0.0001 for superiority). CGM time above 10 mmol/L was 40% at baseline and 34% during follow-up in the CLC group vs. 43% and 39%, respectively, in the SAP group (mean difference -3.0% [95% CI -6.1, 0.1]; P < 0.0001 for noninferiority). One severe hypoglycemic event occurred in the CLC group, which was unrelated to the study device. CONCLUSIONS: In meeting its coprimary end points, superiority of CLC over SAP in CGM-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L, the study has demonstrated that mobile CLC is feasible and could offer certain usability advantages over embedded systems, provided the connectivity between system components is stable.
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: S D Patek; L Magni; E Dassau; C Karvetski; C Toffanin; G De Nicolao; S Del Favero; M Breton; C Dalla Man; E Renard; H Zisser; F J Doyle; C Cobelli; B P Kovatchev Journal: IEEE Trans Biomed Eng Date: 2012-04-03 Impact factor: 4.538
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: Marc D Breton; Daniel R Cherñavvsky; Gregory P Forlenza; Mark D DeBoer; Jessica Robic; R Paul Wadwa; Laurel H Messer; Boris P Kovatchev; David M Maahs Journal: Diabetes Care Date: 2017-08-30 Impact factor: 19.112
Authors: Alessandro Bisio; Linda Gonder-Frederick; Ryan McFadden; Daniel Cherñavvsky; Mary Voelmle; Michael Pajewski; Pearl Yu; Heather Bonner; Sue A Brown Journal: J Diabetes Sci Technol Date: 2021-01-15