Trial reportDiabetes care2022
Safety and Glycemic Outcomes With a Tubeless Automated Insulin Delivery System in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Clinical Trial.
Trial report in Diabetes care, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers, 6 of them syntheses that pooled 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.
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.
Who cites it
49 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- Efficacy and Safety of Tubeless Hybrid Closed-Loop Systems in Type 1 Diabetes: A Meta-Analysis of Randomized Controlled Trials.Diabetes, obesity & metabolism · 2026Pooled it
- Efficacy and safety of hybrid closed-loop systems in children aged < 7 years with type 1 diabetes: a systematic review and meta-analysis of randomized controlled trials.Pediatric diabetes · 2026Pooled it
- Effect of Wearable Technology on Metabolic Control and the Quality of Life in Children and Adolescents with Type 1 Diabetes: A Systematic Review and Meta-AnalysisBalkan medical journal · 2024Pooled it
- Real-World Evidence of Automated Insulin Delivery System Use.Diabetes technology & therapeutics · 2024Pooled it
- International Society for Pediatric and Adolescent Diabetes Clinical Practice Consensus Guidelines 2024: Diabetes Technologies - Insulin Delivery.Hormone research in paediatrics · 2024Guideline
- A Meta-Analysis of Randomized Trial Outcomes for the t:slim X2 Insulin Pump with Control-IQ Technology in Youth and Adults from Age 2 to 72.Diabetes technology & therapeutics · 2023Pooled it
- Extended Use of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 1 Diabetes: 12-Month Extension of a Randomized Controlled Trial.Endocrinology, diabetes & metabolism · 2026Trial
- Psychosocial outcomes among adults with type 1 diabetes using a tubeless automated insulin delivery system compared with sensor augmented pump therapy: A randomised, parallel-group clinical trial sub-study.Diabetes, obesity & metabolism · 2026Trial
- Trial
- Automated Insulin Delivery in Adults With Type 2 Diabetes: A Nonrandomized Clinical Trial.JAMA network open · 2025Trial
- Trial
- Psychosocial outcomes with the Omnipod® 5 Automated Insulin Delivery System in caregivers of very young children with type 1 diabetes.Diabetes, obesity & metabolism · 2024Trial
- Trial of Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes.The New England journal of medicine · 2023Trial
- Omnipod 5 Delivers Superior Economic Value Compared to Multiple Daily Injections: A Cost-Effectiveness Analysis in Adults With T1D From a Payer Perspective in Sweden.Diabetes, obesity & metabolism · 2026Article
- Real-World Effectiveness and Safety of a Tubeless Automated Insulin Delivery System With an Adaptive Control Algorithm (APGO) in Children and Adolescents With Type 1 Diabetes: A Multicentre Observational Study.Diabetes, obesity & metabolism · 2026Observational
- Automated Insulin Delivery Use Among Preschool-Age Children With Type 1 Diabetes: A T1D Exchange Multicenter Analysis.Journal of diabetes science and technology · 2026Article
- Transitioning to Omnipod 5Biomedicines · 2026Article
- Long-term efficacy and safety of Control-IQ technology in younger children with type 1 diabetes in Italy (2020-2023): a longitudinal multicentre real-world study.EClinicalMedicine · 2026Article
- Safety and Glycemic Outcomes Among Youth With New-Onset Type 1 Diabetes Using a Tubeless Automated Insulin Delivery System.Journal of diabetes research · 2026Observational
- Hybrid closed-loop systems in UK type 1 diabetes care: National survey of healthcare professional awareness, confidence, and training needs.Diabetes, obesity & metabolism · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
72 authors.
Funding
Abstract
objectiveVery young children with type 1 diabetes often struggle to achieve glycemic targets, putting them at risk for long-term complications and creating an immense management burden for caregivers. We conducted the first evaluation of the Omnipod 5 Automated Insulin Delivery System in this population. RESEARCH DESIGN AND
methodsA total of 80 children aged 2.0-5.9 years used the investigational system in a single-arm study for 13 weeks following 14 days of baseline data collection with their usual therapy.
resultsThere were no episodes of severe hypoglycemia or diabetic ketoacidosis. By study end, HbA1c decreased by 0.55% (6.0 mmol/mol) (P < 0.0001). Time with sensor glucose levels in target range 70-180 mg/dL increased by 10.9%, or 2.6 h/day (P < 0.0001), while time with levels <70 mg/dL declined by median 0.27% (P = 0.0204).
conclusionsUse of the automated insulin delivery system was safe, and participants experienced improved glycemic measures and reduced hypoglycemia during the study phase compared with baseline.
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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.