Evidence map›Paper›PMID 39884300›Full record

Trial reportThe lancet. Diabetes & endocrinology2025

Automated insulin delivery during the first 6 months postpartum (AiDAPT): a prespecified extension study.

Tara T M Lee, Corinne Collett, Simon Bergford, Sara Hartnell, Eleanor M Scott, Robert S Lindsay, Katharine F Hunt, David R McCance, Rebecca M Reynolds, Malgorzata E Wilinska and 5 more

Abstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The lancet. Diabetes & endocrinology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

10 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Tara T M LeeNorwich Medical School, University of East Anglia, Norwich, UK; Diabetes and Antenatal Care, Norfolk and Norwich NHS Foundation Trust, Norwich, UK.
Corinne CollettNorwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
Simon BergfordJaeb Center for Health Research, Tampa, FL, USA.
Sara HartnellCambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
Eleanor M ScottLeeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
Robert S LindsayInstitute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
Katharine F HuntKing's College Hospital NHS Foundation Trust, London, UK.
David R McCanceRegional Centre for Endocrinology and Diabetes, Royal Victoria Hospital, Belfast, UK.
Rebecca M ReynoldsCentre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.
Malgorzata E WilinskaWellcome-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Judy SibayanJaeb Center for Health Research, Tampa, FL, USA.
Craig KollmanJaeb Center for Health Research, Tampa, FL, USA.
Roman HovorkaWellcome-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Helen R MurphyNorwich Medical School, University of East Anglia, Norwich, UK; Diabetes and Antenatal Care, Norfolk and Norwich NHS Foundation Trust, Norwich, UK. Electronic address: helen.murphy@uea.ac.uk.
AiDAPT Collaborative Group

Funding

Department of Health NIHR203312
6 · The paper itself

Abstract

backgroundClinical guidelines in the UK and elsewhere do not specifically address hybrid closed loop (HCL) use in the postpartum period when the demands of caring for a newborn are paramount. Our aim was to evaluate the safety and efficacy of HCL use during the first 6 months postpartum compared with standard care.

methodsIn this prespecified extension to a multicentre, randomised controlled trial, pregnant women with type 1 diabetes at nine UK sites were followed up for 6 months postpartum. Eligible participants (AiDAPT participants recruited after the implementation of the postpartum protocol amendment approval, those still pregnant or within six months of delivery at the time of amendment implementation and still using HCL or continuous glucose monitoring [CGM] therapy) continued their randomly assigned treatment, either standard insulin therapy with CGM or HCL therapy (CamAPS FX system version 0.3.1, CamDiab, Cambridge, UK). Participants were randomised in a 1:1 ratio with stratification by clinical site using randomly permuted block sizes of 2 or 4. The primary outcome was the between-group difference in percentage time in range ([TIR] 3·9-10·0 mmol/L [70-180mg/dL]), measured during the periods of month 0 up to 3, months 3 to 6, and over 6 months postpartum. The study is registered at ClinicalTrials.gov (ISRCTN56898625) and is complete.

findingsOf the 124 AiDAPT trial participants, 66 (53%) were ineligible for inclusion in the postpartum extension, and 57 participants consented to continue their treatment per original random allocation. The mean age was 31 years (SD 4), and all participants had early pregnancy HbA

interpretationParticipants in the HCL group maintained 70% TIR during the first 6 months postpartum, supporting continued use of HCL rather than standard insulin therapy for people with diabetes once they have given birth.

fundingNational Institute for Health Research, Juvenile Diabetes Research Foundation, and Diabetes Research & Wellness Foundation. CGM devices were provided by Dexcom at a discounted price.

Indexed as

Diabetes Mellitus, Type 1Hypoglycemic AgentsInsulinInsulin Infusion SystemsPostpartum PeriodPregnancy in DiabeticsAdultBlood GlucoseBlood Glucose Self-MonitoringFemaleHumansPregnancyUnited KingdomYoung AdultBlood GlucoseHypoglycemic AgentsInsulin

Identifiers

PMID39884300
PMCPMC7617783

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Registered trials

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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.