Evidence map›Paper›PMID 42083439›Full record

Observational studyJournal of diabetes research2026

Safety and Glycemic Outcomes Among Youth With New-Onset Type 1 Diabetes Using a Tubeless Automated Insulin Delivery System.

Daniel J DeSalvo, Natalie M Linde, James Sickler, Carolina Villegas, Marzia Cescon

Abstract readObservational Study
In one paragraph

Observational study in Journal of diabetes research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Observational
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

5 authors.

Daniel J DeSalvoDepartment of Pediatrics, Baylor College of Medicine, Houston, Texas, USA, bcm.edu.ORCID https://orcid.org/0000-0002-0440-3339
Natalie M LindeDepartment of Mechanical and Aerospace Engineering, University of Houston, Houston, Texas, USA, uh.edu.ORCID https://orcid.org/0009-0003-0922-1547
James SicklerDepartment of Pediatrics, Baylor College of Medicine, Houston, Texas, USA, bcm.edu.
Carolina VillegasDepartment of Pediatrics, Baylor College of Medicine, Houston, Texas, USA, bcm.edu.
Marzia CesconDepartment of Mechanical and Aerospace Engineering, University of Houston, Houston, Texas, USA, uh.edu.ORCID https://orcid.org/0000-0003-4335-6763

Funding

Insulet Corporation
6 · The paper itself

Abstract

introductionAutomated insulin delivery (AID) systems aim to safely optimize glycemic outcomes; however, data in the new-onset type 1 diabetes (T1D) period are limited. We evaluated safety and glycemic outcomes of Omnipod 5 AID System use in the new-onset period.

methodsThis was a retrospective observational analysis of youth at a single center who initiated Omnipod 5 within 90 days of T1D diagnosis. Safety outcomes included diabetic ketoacidosis (DKA) and severe hypoglycemia. Continuous glucose monitoring (CGM) metrics and insulin delivery data were analyzed across the first 3 months of use and between pediatric age groups (<6-year-olds, 6 to <12-year-olds, and 12 to <18-year-olds).

resultsAmong 74 youth initiating Omnipod 5 within 90 days of T1D diagnosis, there was no occurrence of DKA or severe hypoglycemia in the first 3 months of AID system use. The time-weighted average glucose target value on the device setting was 118.8 mg/dL (6.6 mmol/L) with a median of 97% time in Automated Mode over 3 months. Median total daily insulin was 7.4 units (45.5% basal) in <6-year-olds, 11.4 units (48% basal) in 6 to <12-year-olds, and 25.7 units (45% basal) in 12 to <18-year-olds. The median glucose management indicator (GMI) was 7.1% (54 mmol/mol) and time in range (70-180 mg/dL, 3.9-10.0 mmol/L) was 72.1% with minimal hypoglycemia: 1.0% Level 1 time below range (TBR, 54-69 mg/dL, 3.0-3.8 mmol/L) and 0% Level 2 TBR (<54 mg/dL, <3.0 mmol/L).

conclusionThese real-world observational data from youth with new-onset T1D using a tubeless AID system indicate safety and favorable glycemic outcomes with AID system initiation early after diagnosis. Future studies should assess the long-term glycemic and quality of life impact of early AID system adoption.

Indexed as

Blood GlucoseDiabetes Mellitus, Type 1Hypoglycemic AgentsInsulinInsulin Infusion SystemsAdolescentChildContinuous Glucose MonitoringDiabetic KetoacidosisFemaleGlycemic ControlHumansHypoglycemiaMaleRetrospective StudiesTreatment OutcomeBlood GlucoseHypoglycemic AgentsInsulin

Identifiers

PMID42083439
PMCPMC13139763

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.