Evidence map›Paper›PMID 40780817›Full record

ArticleDiabetes technology & therapeutics2026

A Multicenter Study of an Investigational Extended Wear Insulin Infusion Set in Adults with Type 1 Diabetes.

Rayhan A Lal, John W Lum, Zachariah W Reed, Davida Kruger, John Chip Reed, Ruth S Weinstock, Anders L Carlson, Yogish C Kudva, David Liljenquist, Erin C Cobry and 14 more

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in Diabetes technology & therapeutics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06273124 (Open, Single Arm, Prospective, Multicenter Study of an Investigational Extended Wear Insulin Infusion Set During Home Use in People With Type 1 Diabetes), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT06273124 nacompletednot on this map

Open, Single Arm, Prospective, Multicenter Study of an Investigational Extended Wear Insulin Infusion Set During Home Use in People With Type 1 Diabetes

TypeinterventionalSponsorTandem Diabetes Care, Inc.Ran2024 to 2024Enrolled260ConditionsType1diabetesArmsSteadiSet Extended Wear Infusion Set
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Insulin Delivery Hardware: Pumps and Pens.Diabetes technology & therapeutics · 2026
    Article
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

24 authors.

Rayhan A LalDivision of Endocrinology, Gerontology and Metabolism, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.ORCID 0000-0002-8494-1814
John W LumJaeb Center for Health Research, Tampa, Florida, USA.
Zachariah W ReedJaeb Center for Health Research, Tampa, Florida, USA.
Davida KrugerDivision of Endocrinology, Henry Ford Health System, Detroit, Michigan, USA.
John Chip ReedEndocrine Research Solutions, Roswell, Georgia, USA.
Ruth S WeinstockDivision of Endocrinology, Diabetes, and Metabolism, Department of Medicine, SUNY Update Medical University, Syracuse, New York, USA.ORCID 0000-0001-5859-5666
Anders L CarlsonInternational Diabetes Center, HealthPartners Institute, Minneapolis, Minnesota, USA.
Yogish C KudvaDivision of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA.ORCID 0000-0003-0285-6622
David LiljenquistRocky Mountain Clinical Research, Idaho Falls, Idaho, USA.
Erin C CobryBarbara Davis Center for Diabetes, Anschutz Medical Campus, University of Colorado, Aurora, Colorado, USA.
Camilla M LevisterDivision of Endocrinology, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.
Grazia AleppoDivision of Endocrinology, Metabolism and Molecular Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
Jean ChenTexas Diabetes and Endocrinology, Austin, Texas, USA.
David T AhnMary & Dick Allen Diabetes Center, Hoag Memorial Hospital Presbyterian, Newport Beach, California, USA.
Irl B HirschUniversity of Washington School of Medicine, Seattle, Washington, USA.ORCID 0000-0003-1675-8417
Melissa S PutmanDiabetes Research Center, Massachusetts General Hospital, Boston, Massachusetts, USA.
Frances BroylesRainier Clinical Research Center, Renton, Washington, USA.
Jordan E PinskerTandem Diabetes Care, San Diego, California, USA.ORCID 0009-0004-7621-5267
Matt RomeyTandem Diabetes Care, San Diego, California, USA.
Alayne LehmanTandem Diabetes Care, San Diego, California, USA.
Douglas B MuchmoreCapillary Biomedical, San Diego, California, USA.
Craig KollmanJaeb Center for Health Research, Tampa, Florida, USA.
Roy W BeckJaeb Center for Health Research, Tampa, Florida, USA.ORCID 0000-0002-5194-8446

Funding

Stanford Islet Research CoreP30DK116074 · NIDDK · STANFORD UNIVERSITY · PI Seung K Kim · 2017 to 2026
$19.5M
The Optimal Pathway to Implanted Autonomous Insulin DeliveryK23DK122017 · NIDDK · STANFORD UNIVERSITY · PI LAL, RAYHAN · 2020 to 2024
$958k
NIDDK NIH HHS K23 DK122017NIDDK NIH HHS P30 DK116074
6 · The paper itself

Abstract

objectiveTo evaluate the function and safety of the SteadiSet™ infusion set over a continuous 7-day wear period in adults with type 1 diabetes. RESEARCH DESIGN AND

methodsParticipants used a SteadiSet infusion set with a t:slim X2™ insulin pump with Control-IQ™ technology, and either insulin aspart or insulin lispro, for a target of 7 days for 12 consecutive wear periods. Each set removed before 7 days was adjudicated by an independent committee to assess the cause of early removal and to determine whether criteria for primary or key secondary endpoints were met.

resultsThere were 260 participants who inserted 3028 infusion sets. For the primary endpoint, the Kaplan-Meier 7-day survival estimate was 95% (95% CI 94% to 96%). For the key secondary endpoint, which expanded the reasons for a failed infusion set, the Kaplan-Meier 7-day survival estimate was 84% (95% CI 82% to 86%). For both endpoints, the

conclusionsThe 7-day survival of the SteadiSet infusion set was very high for the primary endpoint and at an acceptable level with respect to early removal for any reason related to the device.

Indexed as

Diabetes Mellitus, Type 1Hypoglycemic AgentsInsulinInsulin AspartInsulin Infusion SystemsAdultBlood GlucoseFemaleGlycated HemoglobinHumansInsulin LisproKaplan-Meier EstimateMaleMiddle AgedYoung AdultBlood GlucoseGlycated HemoglobinHypoglycemic AgentsInsulinInsulin AspartInsulin Lisproadultscontinuous subcutaneous insulin infusionextended wearinsertion deviceinsulin infusion set

Identifiers

PMID40780817
PMCPMC12912291

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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 OpenQuestion graph.