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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1630-1640 |
| Number of pages | 11 |
| Journal | Diabetes care |
| Volume | 44 |
| Issue number | 7 |
| DOIs | |
| State | Published - 2021 |
ASJC Scopus subject areas
- Internal Medicine
- Endocrinology, Diabetes and Metabolism
- Advanced and Specialized Nursing
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Multicenter trial of a tubeless, on-body automated insulin delivery system with customizable glycemic targets in pediatric and adult participants with type 1 diabetes. / for the Omnipod 5 Research Group.
In: Diabetes care, Vol. 44, No. 7, 2021, p. 1630-1640.Research output: Contribution to journal › Article › peer-review
TY - JOUR
T1 - Multicenter trial of a tubeless, on-body automated insulin delivery system with customizable glycemic targets in pediatric and adult participants with type 1 diabetes
AU - for the Omnipod 5 Research Group
AU - Brown, Sue A.
AU - Forlenza, Gregory P.
AU - Bode, Bruce W.
AU - Pinsker, Jordan E.
AU - Levy, Carol J.
AU - Criego, Amy B.
AU - Hansen, David W.
AU - Hirsch, Irl B.
AU - Carlson, Anders L.
AU - Bergenstal, Richard M.
AU - Sherr, Jennifer L.
AU - Mehta, Sanjeev N.
AU - Laffel, Lori M.
AU - Shah, Viral N.
AU - Bhargava, Anuj
AU - Weinstock, Ruth S.
AU - Macleish, Sarah A.
AU - Desalvo, Daniel J.
AU - Jones, Thomas C.
AU - Aleppo, Grazia
AU - Buckingham, Bruce A.
AU - Ly, Trang T.
N1 - Funding Information: The authors extend sincere thanks to the participants in this study and their families. The authors also thank Jodi Bernstein, of Jodi Bernstein Medical Writing (Toronto, Ontario, Canada), who received payment from Insulet Corporation for assisting with revisions and formatting of the manuscript. The authors are grateful to the medical monitor, Dr. Roy Beck of the Jaeb Center for Health Research, and the data and safety monitoring board for time spent reviewing the data and providing feedback throughout the study. The authors also thank the Insulet clinical team, including Nikia Trinward, Rachel McElligott, Tanya Meletlides, Anny Fonseca, Michaela Sorrell, Leslie Barrett, Brenda Ferris, and Alex Nguyen, for contributions to the conduct of the study, and the Omnipod 5 research and development teams, including Yi-bin Zheng, Connor Gullifer, Kyle Grover, John Hardy, Steve Cardinali, and Sam Carl, for contributions to the development and technical support of the study device. The authors thank the dedicated staff at each clinical site who made this study possible. Funding and Duality of Interest. This study was funded by Insulet Corporation. S.A.B. reports grants from Insulet and nonfinancial support from Dexcom during the conduct of the study and grants and nonfinancial support from Tandem Diabetes Care, nonfinancial support from Roche Diagnostics, grants from Tolerion, and grants and nonfinancial support from Dexcom outside the submitted work. G.P.F. reports grants and personal fees from Insulet during the conduct of the study and grants and personal fees from Medtronic, grants and personal fees from Dexcom, grants from Abbott, grants and personal fees from Tandem, grants and personal fees from Eli Lilly, and grants and personal fees from Beta Bionics outside the submitted work. B.W.B. reports grant support to his employer Atlanta Diabetes Associates. J.E.P. reports grant support and product support provided to his institution from Insulet, grant support provided to his institution and consulting fees and speaker fees from Tandem Diabetes Care, grant support provided to his institution and advisory board fees from Medtronic, grant support provided to his institution and consulting fees from Eli Lilly, and product support provided to his institution from Dexcom. C.J.L. reports research support from Dexcom and Abbott Diabetes, which have been paid to her institution, and has received an honorarium for serving on an advisory board for Dexcom. A.B.C. reports grants from Insulet during the conduct of the study and grants from Dexcom, grants and other from Medtronic, grants from Abbott Diabetes, grants and other from Sanofi, grants and other from Eli Lilly, and other from Bigfoot Biomedical outside the submitted work. D.W.H. reports grants from Insulet during the conduct of the study and grants from Medtronic and Boehringer Ingelheim. I.B.H. reports research support from Medtronic Diabetes, Insulet, and Beta Bionics and personal fees from Abbott Diabetes Care and Bigfoot Biomedical. A.L.C. reports grants from Insulet during the conduct of the study and grants from Dexcom, grants and other from Medtronic, grants from Abbott Diabetes, grants and other from Sanofi, grants and other from Eli Lilly, and other from Bigfoot Biomedical outside the submitted work. R.B.M. reports research support, consulting, or service on a scientific advisory board for Abbott Diabetes Care, Ascensia, Bigfoot Biomedical, Dexcom, Hygieia, Eli Lilly, Medtronic, Novo Nordisk, Onduo, Roche, Sanofi, and United Healthcare and grants from the National Institutes of Health (NIH)/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and Helmsley Charitable Trust. R.M.B.’s employer, the nonprofit HealthPartners Institute, contracts for his services, and no personal income goes to him. J.L.S. reports research support from Insulet during the conduct of the study and research support from Medtronic and NIDDK. She has served on advisory boards for Bigfoot Biomedical, Cecelia Health, Insulet, and Medtronic Diabetes. Consulting work has been done for Cecelia Health, Eli Lilly, Lexicon, Insulet, Medtronic, and Sanofi. S.N.M. reports grants from Insulet outside the submitted work. L.M.L. reports grants from Insulet during the conduct of the study and personal fees from Novo Nordisk, Eli Lilly, Sanofi, Roche, Johnson & Johnson, Dexcom, Insulet, Boehringer Ingelheim, Convatec, Medtronic, Laxmi, Insulogic, and Lifescan outside the submitted work. V.N.S. reports grants from Dexcom, Insulet, Eli Lilly, Novo Nordisk, Mylan, vTv Therapeutics, EyeNuk, NIH (National Institute of Arthritis and Musculoskeletal and Skin Diseases and NIDDK), and Abbott; grants and other from Sanofi; and other from Medscape outside the submitted work. A.B. reports grant support to his employer Iowa Diabetes Research. R.S.W. reports grants from Insulet during the conduct of the study and grants from Eli Lilly, Medtronic, Tolerion, Diasome Pharmaceuticals, Boehringer Ingelheim, and Kowa outside the submitted work. S.A.M. reports personal fees from Insulet during the conduct of the study. D.J.D. reports grants from Insulet during the conduct of the study and personal fees from Dexcom and Insulet outside the submitted work. T.C.J. reports grant support from Insulet to his employer East Coast Institute for research pertaining to and outside the submitted work. G.A. reports research support from AstraZeneca, Dexcom, Eli Lilly, Insulet, and Novo Nordisk and has served as a consultant for Dexcom and Insulet. B.A.B. reports grants and personal fees from Insulet during the conduct of the study and grants and personal fees from Medtronic, grants and nonfinancial support from Tandem, nonfinancial support from Dexcom outside the submitted work, and grants and personal fees from Convatec. In addition, B.A.B. has a patent (no. 61197230) issued. T.T.L. is a full-time employee of and owns stock in Insulet. No other potential conflicts of interest relevant to this article were reported. Funding Information: Acknowledgments. The authors extend sin cere thanks to the participants in this study and their families. The authors also thank Jodi Bernstein, of Jodi Bernstein Medical Writing (Toronto, Ontario, Canada), who received payment from Insulet Corporation for assisting with revisions and formatting of the manuscript. The authors are grateful to the medical monitor, Dr. Roy Beck of the Jaeb Center for Health Research, and the data and safety monitoring board for time spent reviewing the data and providing feedback throughout the study. The authors also thank the Insulet clinical team, including Nikia Trinward, Rachel McElligott, Tanya Meletlides, Anny Fonseca, Michaela Sorrell, Leslie Barrett, Brenda Ferris, and Alex Nguyen, for contributions to the conduct of the study, and the Omnipod 5 research and development teams, including Yi-bin Zheng, Connor Gullifer, Kyle Grover, John Hardy, Steve Cardinali, and Sam Carl, for contributions to the development and technical support of the study device. The authors thank the dedicated staff at each clinical site who made this study possible. Funding and Duality of Interest. This study was funded by Insulet Corporation. S.A.B. reports grants from Insulet and nonfinancial support from Dexcom during the conduct of the study and grants and nonfinancial support from Tandem Diabetes Care, nonfinancial support from Roche Diagnostics, grants from Tol-erion, and grants and nonfinancial support from Dexcom outside the submitted work. G.P.F. reports grants and personal fees from Insulet during the conduct of the study and grants and personal fees from Medtronic, grants and personal fees from Dexcom, grants from Abbott, grants and personal fees from Tandem, grants and personal fees from Eli Lilly, and grants and personal fees from Beta Bionics outside the submitted work. B.W.B. reports grant support to his employer Atlanta Diabetes Associates. J.E.P. reports grant support and product support provided to his institution from Insulet, grant support provided to his institution and consulting fees and speaker fees from Tandem Diabetes Care, grant support provided to his institution and advisory board fees from Medtronic, grant support provided to his institution and consulting fees from Eli Lilly, and product support provided to his institution from Dexcom. C.J.L. reports research support from Dexcom and Abbott Diabetes, which have been paid to her institution, and has received an honorarium for serving on an advisory board for Dex-com. A.B.C. reports grants from Insulet during the conduct of the study and grants from Dexcom, grants and other from Medtronic, grants from Abbott Diabetes, grants and other from Sanofi, grants and other from Eli Lilly, and other from Bigfoot Biomedical outside the submitted work. D.W.H. reports grants from Insulet during the conduct of the study and grants from Medtronic and Boehringer Ingelheim. I.B.H. reports research support from Medtronic Diabetes, Insulet, and Beta Bionics and personal fees from Abbott Diabetes Care and Bigfoot Biomedical. A.L.C. reports grants from Insulet during the conduct of the study and grants from Dexcom, grants and other from Medtronic, grants from Abbott Diabetes, grants and other from Sanofi, grants and other from Eli Lilly, and other from Bigfoot Biomedical outside the submitted work. R.B.M. reports research support, consulting, or service on a scientific advisory board for Abbott Diabetes Care, Ascensia, Bigfoot Biomedical, Dexcom, Hygieia, Eli Lilly, Medtronic, Novo Nordisk, Onduo, Roche, Sa-nofi, and United Healthcare and grants from the National Institutes of Health (NIH)/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and Helmsley Charitable Trust. R.M.B.’s employer, the nonprofit HealthPartners Institute, contracts for his services, and no personal income goes to him. J.L.S. reports research support from Insu-let during the conduct of the study and research support from Medtronic and NIDDK. She has served on advisory boards for Bigfoot Biomedical, Cecelia Health, Insulet, and Med-tronic Diabetes. Consulting work has been done for Cecelia Health, Eli Lilly, Lexicon, Insu-let, Medtronic, and Sanofi. S.N.M. reports grants from Insulet outside the submitted work. L.M.L. reports grants from Insulet during the conduct of the study and personal fees from Novo Nordisk, Eli Lilly, Sanofi, Roche, Johnson & Johnson, Dexcom, Insulet, Boehringer Ingelheim, Convatec, Medtronic, Laxmi, Insulogic, and Lifescan outside the submitted work. V.N.S. reports grants from Dex-com, Insulet, Eli Lilly, Novo Nordisk, Mylan, vTv Therapeutics, EyeNuk, NIH (National Institute of Arthritis and Musculoskeletal and Skin Diseases and NIDDK), and Abbott; grants and other from Sanofi; and other from Medscape outside the submitted work. A.B. reports grant support to his employer Iowa Diabetes Research. R.S.W. reports grants from Insulet during the conduct of the study and grants from Eli Lilly, Medtronic, Tolerion, Diasome Pharmaceuticals, Boehringer Ingelheim, and Kowa outside the submitted work. S.A.M. reports personal fees from Insulet during the conduct of the study. D.J.D. reports grants from Insulet during the conduct of the study and personal fees from Dexcom and Insulet outside the submitted work. T.C.J. reports grant support from Insulet to his employer East Coast Institute for research pertaining to and outside the submitted work. G.A. reports research support from AstraZeneca, Dexcom, Eli Lilly, Insulet, and Novo Nordisk and has served as a consultant for Dexcom and Insu-let. B.A.B. reports grants and personal fees from Insulet during the conduct of the study and grants and personal fees from Medtronic, grants and nonfinancial support from Tandem, nonfinancial support from Dexcom outside the submitted work, and grants and personal fees from Convatec. In addition, B.A.B. has a patent (no. 61197230) issued. T.T.L. is a full-time employee of and owns stock in Insulet. No other potential conflicts of interest relevant to this article were reported. Publisher Copyright: © 2021, American Diabetes Association Inc.. All rights reserved.
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85114450655&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85114450655&partnerID=8YFLogxK
U2 - 10.2337/dc21-0172
DO - 10.2337/dc21-0172
M3 - Article
C2 - 34099518
AN - SCOPUS:85114450655
SN - 1935-5548
VL - 44
SP - 1630
EP - 1640
JO - Diabetes Care
JF - Diabetes Care
IS - 7
ER -