Journal article
Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes
Diabetes care, v 44(7), pp 1630-1640
01 Jul 2021
PMID: 34099518
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
OBJECTIVE
Advances in diabetes technology have transformed the treatment paradigm for type 1 diabetes, yet the burden of disease is significant. We report on a pivotal safety study of the first tubeless, on-body automated insulin delivery system with customizable glycemic targets.
RESEARCH DESIGN AND METHODS
This single-arm, multicenter, prospective study enrolled 112 children (age 6–13.9 years) and 129 adults (age 14–70 years). A 2-week standard therapy phase (usual insulin regimen) was followed by 3 months of automated insulin delivery. Primary safety outcomes were incidence of severe hypoglycemia and diabetic ketoacidosis. Primary effectiveness outcomes were change in HbA1c and percent time in sensor glucose range 70–180 mg/dL (“time in range”).
RESULTS
A total of 235 participants (98% of enrolled, including 111 children and 124 adults) completed the study. HbA1c was significantly reduced in children by 0.71% (7.8 mmol/mol) (mean ± SD: 7.67 ± 0.95% to 6.99 ± 0.63% [60 ± 10.4 mmol/mol to 53 ± 6.9 mmol/mol], P < 0.0001) and in adults by 0.38% (4.2 mmol/mol) (7.16 ± 0.86% to 6.78 ± 0.68% [55 ± 9.4 mmol/mol to 51 ± 7.4 mmol/mol], P < 0.0001). Time in range was improved from standard therapy by 15.6 ± 11.5% or 3.7 h/day in children and 9.3 ± 11.8% or 2.2 h/day in adults (both P < 0.0001). This was accomplished with a reduction in time in hypoglycemia <70 mg/dL among adults (median [interquartile range]: 2.00% [0.63, 4.06] to 1.09% [0.46, 1.75], P < 0.0001), while this parameter remained the same in children. There were three severe hypoglycemia events not attributable to automated insulin delivery malfunction and one diabetic ketoacidosis event from an infusion site failure.
CONCLUSIONS
This tubeless automated insulin delivery system was safe and allowed participants to significantly improve HbA1c levels and time in target glucose range with a very low occurrence of hypoglycemia.
Metrics
Details
- Title
- Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes
- Creators
- Omnipod 5 Research GroupSue A. Brown - University of VirginiaGregory P. Forlenza - University of Colorado Anschutz Medical CampusBruce W. Bode - Atlanta Diabetes AssociatesJordan E. Pinsker - Sansum Diabetes Research InstituteCarol J. Levy - Icahn School of Medicine at Mount SinaiAmy B. Criego - Park Nicollet ClinicDavid W. Hansen - SUNY Upstate Medical UniversityIrl B. Hirsch - University of WashingtonAnders L. Carlson - Park Nicollet ClinicRichard M. Bergenstal - Park Nicollet ClinicJennifer L. Sherr - Yale UniversityLori M. Laffel - Joslin Diabetes CenterViral N. Shah - University of Colorado Anschutz Medical CampusAnuj Bhargava - Iowa Diabetes and Endocrinology Research CenterRuth S. Weinstock - SUNY Upstate Medical UniversitySarah A. MacLeish - Rainbow Babies & Children's HospitalDaniel J. DeSalvo - Baylor College of MedicineThomas C. Jones - Jones InstituteGrazia Aleppo - Northwestern UniversityBruce A. Buckingham - Stanford UniversityTrang T. Ly - InsuletMary VoelmleEmma EmoryR. Paul WadwaRobert SloverErin CobryLaurel H. MesserCari BergetSusan McCoyHalis K. AkturkNicole SchneiderHal JosephPrakriti JosheeChristie BeatsonBrooke NarronTricia LopezMei Mei ChurchKristin CastorinoMolly PiperJimena PerezDavid W. LamCamilla LevisterGrenye O’MalleySelassie OgyaaduDushyanthy ArasaratnamMitchell PlesserEmily NosovaSuzan BzdickSheri L. StoneSubbulaxmi TrikudanathanNancy SanbornDori KhakpourThomas Martens - Jones InstituteAimee GriemeJamie HyattAlina PunelDiane WhippleMichelle Van NameMichelle BreiMelinda ZgorskiAmy Steffen - Park Nicollet ClinicLori Carria - Joslin Diabetes CenterSanjeev N. Mehta - Joslin Diabetes CenterLindsay RoethkeMargaret FisherRebecca Ortiz La BancaLisa VolkeningLouise Ambler-OsbornChristine TurcotteEmily F. FreinerLisa BorgJamie R. WoodBeth A. KaminskiTerri L. CaseyWendy CampbellSiripoom McKayMary Kylie DeLaOCarolina VillegasBarry Russel JohnsAshwini GoreLeslie Harvill
- Publication Details
- Diabetes care, v 44(7), pp 1630-1640
- Publisher
- American Diabetes Association
- Number of pages
- 11
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Pediatrics
- Web of Science ID
- WOS:000678813200028
- Scopus ID
- 2-s2.0-85114450655
- Other Identifier
- 991021930898504721
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Endocrinology & Metabolism