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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
Open accessPublished version of a preprint
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.
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“Omnipod 5 118 and, most recently Tidepool Loop, 119 were cleared by FDA as well.”
From Developing the UVA/Padova Type 1 Diabetes Simulator: Modeling, Validation, Refinements, and Utility (2023) · cites this paper as [118]
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“Our results also showed safety outcomes that are comparable to other short-duration AID studies, showing no DKA or severe hypoglycemia events and very little time spent in level 1 and level 2 hypoglycemia.”
From Clinical utility of the twiist Automated Insulin Delivery System: first study with twiist (2026) · cites this paper as [18]
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“For example, Brown et al reported one DKA event and three severe hypoglycemia events in their 3-month study of 111 children and 124 adults using the Omnipod 5 AID System.18”
From Clinical utility of the twiist Automated Insulin Delivery System: first study with twiist (2026) · cites this paper as [18]
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“In conjunction with anti-IL-21 antibody, liraglutide was shown to provide small improvements of endogenous insulin secretion.1176”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [1176]
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Metadata
- Authors
- Brown, S. A., Forlenza, G. P., Bode, B. W., Pinsker, J. E., Levy, C. J., Criego, A. B., Hansen, D. W., Hirsch, I. B., Carlson, A. L., Bergenstal, R. M., Sherr, J. L., Mehta, S. N., Laffel, L. M., Shah, V. N., Bhargava, A., Weinstock, R. S., MacLeish, S. A., DeSalvo, D. J., Jones, T. C., Aleppo, G., Buckingham, B. A., Ly, T. T., Omnipod 5 Research Group, Brown, S. A., Voelmle, M., Emory, E., Forlenza, G. P., Wadwa, R. P., Slover, R., Cobry, E., Messer, L. H., Berget, C., McCoy, S., Shah, V. N., Akturk, H. K., Schneider, N., Joseph, H., Joshee, P., Beatson, C., Bode, B. W., Narron, B., Lopez, T., Pinsker, J. E., Church, M. M., Castorino, K., Piper, M., Perez, J., Levy, C. J., Lam, D. W., Levister, C., O’Malley, G., Ogyaadu, S., Arasaratnam, D., Plesser, M., Nosova, E., Bzdick, S., Hansen, D. W., Stone, S. L., Weinstock, R. S., Hirsch, I. B., Trikudanathan, S., Sanborn, N., Khakpour, D., Carlson, A. L., Criego, A. B., Bergenstal, R. M., Martens, T., Grieme, A., Hyatt, J., Punel, A., Whipple, D., Sherr, J. L., Van Name, M., Brei, M., Zgorski, M., Steffen, A., Carria, L., Mehta, S. N., Laffel, L. M., Roethke, L., Fisher, M., Ortiz La Banca, R., Volkening, L., Ambler-Osborn, L., Turcotte, C., Freiner, E. F., Bhargava, A., Borg, L., MacLeish, S. A., Wood, J. R., Kaminski, B. A., Casey, T. L., Campbell, W., DeSalvo, D. J., McKay, S., DeLaO, M. K., Villegas, C., Jones, T. C., Russel Johns, B., Gore, A., Harvill, L., Merritt, K., Stanfield, J., Sheldon, J., Hichkad, L., Burnett, E., Castelot, A., Bounds, L., Preston, K., Goldfaden, R., Aleppo, G., Kravarusic, J., Bansal, A., Buckingham, B. A., Ekhlaspour, L., Kingman, R., Kivilaid, K., Kleve, K., Ly, T. T., Dumais, B., Vienneau, T., Huyett, L. M., Lee, J. B., O’Connor, J., & Benjamin, E.
- Affiliations
- Park Nicollet Health Services (US)
- Joslin Diabetes Center (US)
- Yale University (US)
- ORCID
- Wadwa, R. Paul
- Cobry, Erin
- Messer, Laurel H.
- Berget, Cari
- Schneider, Nicole
- Beatson, Christie
- Church, Mei Mei
- Castorino, Kristin
- Lam, David W.
- O’Malley, Grenye
- Nosova, Emily
- Stone, Sheri L.
- Trikudanathan, Subbulaxmi
- Khakpour, Dori
- Volkening, Lisa
- Freiner, Emily F.
- Wood, Jamie R.
- Kaminski, Beth A.
- McKay, Siripoom
- Goldfaden, Rebecca
- Ekhlaspour, Laya
- Kingman, Ryan
- Huyett, Lauren M.
- O’Connor, Jason
- Benjamin, Eric
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2021-07-01
- Volume
- 44
- Issue
- 7
- Pages
- 1630-1640
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- PMC
- PMC8323171
- OpenAlex
- W3166779635
- Cited by
- 286
- References
- 24
- Citations by year
- 2026: 33 · 2025: 72 · 2024: 53 · 2023: 64 · 2022: 53 · 2021: 11
- FWCI
- 33.78
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Care (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Insulet Corporation
- National Institutes of Health (UL1TR001422, UL1TR001863)
- National Institute of Diabetes and Digestive and Kidney Diseases (P60DK020541, P30DK036836, P30DK020541, P30DK045735)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Keywords
- type 1 diabetes, artificial pancreas, glycemic targets, HbA1c, time in range, hypoglycemia, diabetic ketoacidosis, type 1 diabetes in children, adults with type 1 diabetes, diabetes technology, glycemic control, safety and effectiveness, continuous glucose monitoring
- MeSH terms
- Adolescent, Adult, Aged, Blood Glucose, Child, Diabetes Mellitus, Type 1, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Middle Aged, Prospective Studies, Young Adult
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