Evidence map›Paper›PMID 31140654›Full record

Trial reportPediatric diabetes2019

Reduced burden of diabetes and improved quality of life: Experiences from unrestricted day-and-night hybrid closed-loop use in very young children with type 1 diabetes.

Gianluca Musolino, Klemen Dovc, Charlotte K Boughton, Martin Tauschmann, Janet M Allen, Katrin Nagl, Maria Fritsch, James Yong, Emily Metcalfe, Dominique Schaeffer and 21 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Pediatric diabetes, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04759144 (A Randomised Crossover Study Comparing Hybrid Closed-loop Insulin Delivery Using Ultra-rapid Acting Insulin to Hybrid Closed-loop Insulin Delivery Using Standard Rapid-acting Insulin in Children With Type 1 Diabetes in the Home Setting), which is not on this map. Cited by 49 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing 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.

NCT04759144 nacompletednot on this mapstarted 2021, after this paper: background citation

A Randomised Crossover Study Comparing Hybrid Closed-loop Insulin Delivery Using Ultra-rapid Acting Insulin to Hybrid Closed-loop Insulin Delivery Using Standard Rapid-acting Insulin in Children With Type 1 Diabetes in the Home Setting (FAST-Kids)

TypeinterventionalSponsorUniversity of CambridgeRan2021 to 2022Enrolled27ConditionsType 1 Diabetes MellitusArmsCamAPS FX using faster insulin aspart, CamAPS FX using standard insulin aspart
3 · Its place in the literature

Who cites it

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

  1. Guideline
  2. Pooled it
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  14. Observational
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  19. Review
  20. A Systematic Review of Commercial Hybrid Closed-Loop Automated Insulin Delivery Systems.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023 · on this map
    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

31 authors.

Gianluca MusolinoWellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.ORCID 0000-0002-4313-2834
Klemen DovcDepartment of Paediatric Endocrinology, Diabetes and Metabolic Diseases, University Children's Hospital, University Medical Centre, Ljubljana, Slovenia.ORCID 0000-0001-9201-2145
Charlotte K BoughtonWellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Martin TauschmannWellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Janet M AllenWellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Katrin NaglDepartment of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria.ORCID 0000-0001-6489-9068
Maria FritschDepartment of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria.
James YongDepartment of Paediatric Diabetes, Leeds Children's Hospital, Leeds, UK.
Emily MetcalfeDepartment of Paediatric Diabetes, Leeds Children's Hospital, Leeds, UK.
Dominique SchaefferDepartment of Pediatric Diabetes and Endocrinology, Clinique Pédiatrique, Centre Hospitalier, Luxembourg City, Luxembourg.
Muriel FichelleDepartment of Pediatric Diabetes and Endocrinology, Clinique Pédiatrique, Centre Hospitalier, Luxembourg City, Luxembourg.
Ulrike SchierlohDepartment of Pediatric Diabetes and Endocrinology, Clinique Pédiatrique, Centre Hospitalier, Luxembourg City, Luxembourg.ORCID 0000-0002-7644-4818
Alena G ThieleDivision for Paediatric Diabetology, University of Leipzig, Leipzig, Germany.
Daniela AbtDepartment of Pediatrics I, Medical University of Innsbruck, Innsbruck, Austria.
Harald KojzarDepartment of Internal Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.
Julia K MaderDepartment of Internal Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.
Sonja SlegtenhorstDepartment of Nutrition & Dietetics, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
Nicole AshcroftWellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Malgorzata E WilinskaWellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Judy SibayanJaeb Center for Health Research, Tampa, Florida.
Nathan CohenJaeb Center for Health Research, Tampa, Florida.
Craig KollmanJaeb Center for Health Research, Tampa, Florida.
Sabine E HoferDepartment of Pediatrics I, Medical University of Innsbruck, Innsbruck, Austria.ORCID 0000-0001-6778-0062
Elke Fröhlich-ReitererDepartment of Pediatrics and Adolescent Medicine, Medical University of Graz, Graz, Austria.
Thomas M KapellenDivision for Paediatric Diabetology, University of Leipzig, Leipzig, Germany.
Carlo L AceriniDepartment of Paediatrics, University of Cambridge, Cambridge, UK.ORCID 0000-0003-2121-5871
Carine de BeaufortDepartment of Pediatric Diabetes and Endocrinology, Clinique Pédiatrique, Centre Hospitalier, Luxembourg City, Luxembourg.
Fiona CampbellDepartment of Paediatric Diabetes, Leeds Children's Hospital, Leeds, UK.
Birgit Rami-MerharDepartment of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria.ORCID 0000-0001-5575-5222
Roman HovorkaWellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.ORCID 0000-0003-2901-461X
Kidsap Consortium

Funding

Department of HealthJuvenile Diabetes Research Foundation 3-SRA-2016-297-M-NWellcome Trust
6 · The paper itself

Abstract

objectiveTo evaluate the experiences of families with very young children aged 1 to 7 years (inclusive) with type 1 diabetes using day-and-night hybrid closed-loop insulin delivery.

methodsParents/caregivers of 20 children aged 1 to 7 years with type 1 diabetes completed a closed-loop experience survey following two 3-week periods of unrestricted day-and-night hybrid closed-loop insulin therapy using Cambridge FlorenceM system at home. Benefits, limitations, and improvements of closed-loop technology were explored.

resultsResponders reported reduced burden of diabetes management, less time spent managing diabetes, and improved quality of sleep with closed-loop. Ninety percent of the responders felt less worried about their child's glucose control using closed-loop. Size of study devices, battery performance and connectivity issues were identified as areas for improvement. Parents/caregivers wished for more options to input information to the system such as temporary glucose targets.

conclusionsParents/caregivers of very young children reported important quality of life benefits associated with using closed-loop, supporting adoption of this technology in this population.

Indexed as

Cost of IllnessInsulin Infusion SystemsQuality of LifeBlood GlucoseBlood Glucose Self-MonitoringCaregiversChildChild, PreschoolCircadian RhythmCross-Over StudiesDiabetes Mellitus, Type 1FamilyFemaleHumansInfantInsulinBlood GlucoseInsulinartificial pancreasclosed-loop insulin deliverytype 1 diabetesvery young children

Identifiers

PMID31140654
PMCPMC6771658

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.