Evidence mapPaperPMID 38924772Full record

Trial reportDiabetes care2024

Effect of 48 Months of Closed-Loop Insulin Delivery on Residual C-Peptide Secretion and Glycemic Control in Newly Diagnosed Youth With Type 1 Diabetes: A Randomized Trial.

Julia Ware, Charlotte K Boughton, Janet M Allen, Malgorzata E Wilinska, Sara Hartnell, Ajay Thankamony, Tabitha Randell, Atrayee Ghatak, Rachel E J Besser, Daniela Elleri and 8 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Diabetes care, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06919029 (Assessing the Effect of Advanced Hybrid Closed Loop System, MiniMed 780G With GS4 Glucose Sensor in Newly Diagnosed Children and Adolescents With Type 1 Diabetes on Glycemic Control and Patient Reported Outcomes Compared to Standard Insulin Therapy Historical Data), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
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.

NCT06919029 recruitingnot on this mapstarted 2025, after this paper: background citation

Assessing the Effect of Advanced Hybrid Closed Loop System, MiniMed 780G With GS4 Glucose Sensor in Newly Diagnosed Children and Adolescents With Type 1 Diabetes on Glycemic Control and Patient Reported Outcomes Compared to Standard Insulin Therapy Historical Data (AHCL in New Onset T1D Children Study): a Single Arm Open- Label Prospective Observational Study Protocol

TypeobservationalSponsorNational and Kapodistrian University of AthensRan2025 to 2026Enrolled30ConditionsDiabetes Mellitus, Type IArmsAdvanced Hybrid Closed Loop from onset of type 1 diabetes in children
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. [Diabetes technology (Update 2026)].Wiener klinische Wochenschrift · 2026
    Guideline
  2. Guideline
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Article
  8. Effect of Automated Insulin Delivery System Therapy at Diagnosis on Metabolic Control in Children and Adolescents with Type 1 Diabetes.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025
    Article
  9. Review
  10. Review
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

18 authors.

Julia WareInstitute of Metabolic Science-Metabolic Research Laboratories and Medical Research Council Metabolic Diseases Unit, University of Cambridge, Cambridge, U.K.ORCID 0000-0002-4497-0979
Charlotte K BoughtonInstitute of Metabolic Science-Metabolic Research Laboratories and Medical Research Council Metabolic Diseases Unit, University of Cambridge, Cambridge, U.K.ORCID 0000-0003-3272-9544
Janet M AllenInstitute of Metabolic Science-Metabolic Research Laboratories and Medical Research Council Metabolic Diseases Unit, University of Cambridge, Cambridge, U.K.
Malgorzata E WilinskaInstitute of Metabolic Science-Metabolic Research Laboratories and Medical Research Council Metabolic Diseases Unit, University of Cambridge, Cambridge, U.K.
Sara HartnellWolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals National Health Service Foundation Trust, Cambridge, U.K.
Ajay ThankamonyDepartment of Paediatrics, University of Cambridge, Cambridge, U.K.
Tabitha RandellDepartment of Paediatric Diabetes and Endocrinology, Nottingham Children's Hospital, Nottingham, U.K.
Atrayee GhatakDepartment of Diabetes, Alder Hey Children's National Health Service Foundation Trust, Liverpool, U.K.
Rachel E J BesserDepartment of Paediatrics, University of Oxford, Oxford, U.K.ORCID 0000-0002-4645-6324
Daniela ElleriDepartment of Diabetes, Royal Hospital for Sick Children, Edinburgh, U.K.
Nicola TrevelyanPaediatric Diabetes, Southampton Children's Hospital, Southampton, U.K.
Fiona M CampbellDepartment of Paediatric Diabetes, Leeds Children's Hospital, Leeds, U.K.ORCID 0000-0002-7618-6759
Judy SibayanJaeb Center for Health Research, Tampa, FL.
Ryan BaileyJaeb Center for Health Research, Tampa, FL.
Peter CalhounJaeb Center for Health Research, Tampa, FL.
Gareth DunseathDiabetes Research Group, Swansea University, Swansea, U.K.ORCID 0000-0001-6022-862X
Roman HovorkaInstitute of Metabolic Science-Metabolic Research Laboratories and Medical Research Council Metabolic Diseases Unit, University of Cambridge, Cambridge, U.K.ORCID 0000-0003-2901-461X
CLOuD Consortium

Funding

Breakthrough T1D 2-RSC-2019-828-M-NEfficacy and Mechanism Evaluation Programme 14/23/09Leona M. and Harry B. Helmsley Charitable Trust 2016PG-T1D045NIHR Cambridge Biomedical Research CentreNIHR Oxford Biomedical Research CentreWellcome Trust
6 · The paper itself

Abstract

objectiveWe evaluated the effect of long-term intensive metabolic control with hybrid closed-loop (CL) on residual C-peptide secretion and glucose control compared with standard insulin therapy in youth with type 1 diabetes over 48 months. RESEARCH DESIGN AND

methodsFollowing the 24-month primary phase of a multicenter, randomized, parallel trial of 96 newly diagnosed youth aged 10 to 16.9 years, participants were invited to an extension phase using treatment allocated at randomization. They continued with hybrid CL using the Cambridge algorithm or standard insulin therapy (control) until 48 months after diagnosis. Analysis was by intention-to-treat.

resultsAt 24 months after diagnosis, 81 participants (mean ± SD age 14 ± 2 years) continued in the extension phase (47 CL, 34 control). There was no difference in fasting C-peptide corrected for fasting glucose at 48 months between groups (CL: 5 ± 9 vs. control: 6 ± 14 pmol/L per mmol/L; mean adjusted difference -2 [95% CI -7, 4; P = 0.54]). Central laboratory HbA1c remained lower in the CL group by 0.9% (10 mmol/mol [95% CI 0.2, 1.5; 3, 17 mmol/mol); P = 0.009). Time in target range of 3.9 to 10.0 mmol/L was 12 percentage points (95% CI 3, 20; P = 0.008) higher in the CL group compared with control. There were 11 severe hypoglycemic events (6 CL, 5 control) and 7 diabetic ketoacidosis events (3 CL, 4 control) during the extension phase.

conclusionsImproved glycemic control was sustained over 48 months after diagnosis with CL insulin delivery compared with standard therapy in youth with type 1 diabetes. This did not appear to confer a protective effect on residual C-peptide secretion.

Indexed as

Blood GlucoseC-PeptideDiabetes Mellitus, Type 1Glycemic ControlInsulinInsulin Infusion SystemsAdolescentChildFemaleGlycated HemoglobinHumansHypoglycemic AgentsMaleBlood GlucoseC-PeptideGlycated HemoglobinHypoglycemic AgentsInsulin

Identifiers

PMID38924772
PMCPMC11272979

What Socratic holds

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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 Socratic graph.