Evidence mapPaperPMID 34099518Full record

ArticleDiabetes care2021

Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes.

Sue A Brown, Gregory P Forlenza, Bruce W Bode, Jordan E Pinsker, Carol J Levy, Amy B Criego, David W Hansen, Irl B Hirsch, Anders L Carlson, Richard M Bergenstal and 13 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter Study
In one paragraph

Article in Diabetes care, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07696039 (Real-world Effectiveness and Safety of Omnipod 5 in Adults With Type 1 Diabetes), which is not on this map. Cited by 143 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
143citing papers in PubMed, 8 pooled it
26.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07696039 completednot on this mapstarted 2026, after this paper: background citation

Real-world Effectiveness and Safety of Omnipod 5 in Adults With Type 1 Diabetes: a 12-month Observational Study.

TypeobservationalSponsorPapa Giovanni XXIII HospitalRan2026 to 2026Enrolled300ConditionsType 1 Diabetes Mellitus
3 · Its place in the literature

Who cites it

143 citing papers in PubMed, 8 syntheses or guidelines pooled it, 258 citations in OpenAlex.

  1. Pooled it
  2. Continuous glucose monitoring in type 2 diabetes: a systematic review of barriers and opportunities for care improvement.International journal for quality in health care : journal of the International Society for Quality in Health Care · 2025
    Pooled it
  3. Pooled it
  4. Real-World Evidence of Automated Insulin Delivery System Use.Diabetes technology & therapeutics · 2024
    Pooled it
  5. Pooled it
  6. Guideline
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  8. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
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83 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors at 17 institutions in 1 country.

Sue A BrownDivision of Endocrinology, Center for Diabetes Technology, University of Virginia, Charlottesville, VA.
Gregory P ForlenzaBarbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO.
Bruce W BodeAtlanta Diabetes Associates, Atlanta, GA.
Jordan E PinskerSansum Diabetes Research Institute, Santa Barbara, CA.ORCID 0000-0003-4080-9034
Carol J LevyIcahn School of Medicine at Mount Sinai, New York, NY.ORCID 0000-0002-3492-2578
Amy B CriegoInternational Diabetes Center, Park Nicollet Pediatric Endocrinology, Minneapolis, MN.
David W HansenDepartment of Pediatrics, SUNY Upstate Medical University, Syracuse, NY.
Irl B HirschDepartment of Medicine, University of Washington, Seattle, WA.ORCID 0000-0003-1675-8417
Anders L CarlsonInternational Diabetes Center, Park Nicollet, HealthPartners, Minneapolis, MN.
Richard M BergenstalInternational Diabetes Center, Park Nicollet, HealthPartners, Minneapolis, MN.ORCID 0000-0002-9050-5584
Jennifer L SherrDepartment of Pediatrics, Yale School of Medicine, New Haven, CT.ORCID 0000-0001-9301-3043
Sanjeev N MehtaJoslin Diabetes Center, Harvard Medical School, Boston, MA.ORCID 0000-0001-6059-4611
Lori M LaffelJoslin Diabetes Center, Harvard Medical School, Boston, MA.ORCID 0000-0002-9675-3001
Viral N ShahBarbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO.ORCID 0000-0002-3827-7107
Anuj BhargavaDepartment of Research, Iowa Diabetes Research, West Des Moines, IA.
Ruth S WeinstockDepartment of Medicine, SUNY Upstate Medical University, Syracuse, NY.ORCID 0000-0001-5859-5666
Sarah A MacLeishDepartment of Pediatrics, University Hospitals Cleveland Medical Center, Rainbow Babies and Children's Hospital, Cleveland, OH.
Daniel J DeSalvoDepartment of Pediatrics, Baylor College of Medicine, Houston, TX.ORCID 0000-0002-0440-3339
Thomas C JonesDepartment of Research, East Coast Institute for Research at The Jones Center, Macon, GA.
Grazia AleppoFeinberg School of Medicine, Northwestern University, Chicago, IL.ORCID 0000-0003-1644-5947
Bruce A BuckinghamDepartment of Pediatrics, Division of Pediatric Endocrinology, Stanford University, Stanford, CA.
Omnipod 5 Research Group
Park Nicollet Clinic · USJoslin Diabetes Center · USSUNY Upstate Medical University · USUniversity of Colorado Anschutz Medical Campus · USYale University · USJones Institute · USAtlanta Diabetes Associates · USBaylor College of Medicine · USIcahn School of Medicine at Mount Sinai · USInsulet (United States) · USIowa Diabetes and Endocrinology Research Center · USNorthwestern University · USRainbow Babies & Children's Hospital · USSansum Diabetes Research Institute · USStanford University · USUniversity of Virginia · USUniversity of Washington · US

Funding

PROMOTING OPHTHALMIC SCREENING IN MANAGED CAREP60DK020541 · YESHIVA UNIVERSITY · 1986 to 2005
$12.6M
PILOT STUDY--SECRETORY TARGETING IN PANCREATIC B CELLSP30DK036836 · JOSLIN DIABETES CENTER · 1986 to 2025
$12.1M
Yale Diabetes Research CenterP30DK045735 · YALE UNIVERSITY · 1993 to 2025
$10.2M
Yale Clinical and Translational Science AwardUL1TR001863 · YALE UNIVERSITY · 2025 to 2025
$9.9M
NYR-Diabetes Research Center (NYR-DRC)P30DK020541 · ALBERT EINSTEIN COLLEGE OF MEDICINE · 2025 to 2025
$2.4M
NCATS NIH HHS UL1 TR001422NCATS NIH HHS UL1 TR001863NIDDK NIH HHS P30 DK020541NIDDK NIH HHS P30 DK036836NIDDK NIH HHS P30 DK045735NIDDK NIH HHS P60 DK020541
6 · The paper itself

Abstract

objectiveAdvances 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

methodsThis 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 HbA

resultsA total of 235 participants (98% of enrolled, including 111 children and 124 adults) completed the study. HbA

conclusionsThis tubeless automated insulin delivery system was safe and allowed participants to significantly improve HbA

Indexed as

Diabetes Mellitus, Type 1InsulinAdolescentAdultAgedBlood GlucoseChildGlycated HemoglobinHumansHypoglycemic AgentsInsulin Infusion SystemsMiddle AgedProspective StudiesYoung AdultBlood GlucoseGlycated HemoglobinHypoglycemic AgentsInsulin

Identifiers

PMID34099518
PMCPMC8323171
OpenAlexW3166779635

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.