Evidence map›Paper›PMID 29886443›Full record

ArticleBMJ open2018

Effect of 6 months of hybrid closed-loop insulin delivery in adults with type 1 diabetes: a randomised controlled trial protocol.

Sybil A McAuley, Martin I de Bock, Vijaya Sundararajan, Melissa H Lee, Barbora Paldus, Geoff R Ambler, Leon A Bach, Morton G Burt, Fergus J Cameron, Philip M Clarke and 23 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
3.3field-weighted citation impact, top 7% of its field
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

7 citing papers in PubMed, 29 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Improving patient self-care using diabetes technologies.Therapeutic advances in endocrinology and metabolism · 2019
    Review
  6. Review
  7. 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

33 authors at 15 institutions in 3 countries.

Sybil A McAuleyDepartment of Medicine, University of Melbourne, Melbourne, Victoria, Australia.
Martin I de BockDepartment of Endocrinology and Diabetes, Princess Margaret Hospital for Children, Perth, Western Australia, Australia.
Vijaya SundararajanDepartment of Medicine, University of Melbourne, Melbourne, Victoria, Australia.
Melissa H LeeDepartment of Medicine, University of Melbourne, Melbourne, Victoria, Australia.
Barbora PaldusDepartment of Medicine, University of Melbourne, Melbourne, Victoria, Australia.
Geoff R AmblerInstitute of Endocrinology and Diabetes, The Children's Hospital at Westmead, Sydney, New South Wales, Australia.
Leon A BachDepartment of Endocrinology and Diabetes, Alfred Hospital, Melbourne, Victoria, Australia.
Morton G BurtSouthern Adelaide Diabetes and Endocrine Services, Flinders Medical Centre, Adelaide, South Australia, Australia.
Fergus J CameronDepartment ofEndocrinology and Diabetes and Centre for Hormone Research, Royal Children'sHospital, Melbourne, Victoria, Australia.
Philip M ClarkeMelbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.
Neale D CohenBaker Heart and Diabetes Institute, Melbourne, Victoria, Australia.
Peter G ColmanDepartment of Diabetes and Endocrinology, Royal Melbourne Hospital, Melbourne, Victoria, Australia.
Elizabeth A DavisDepartment of Endocrinology and Diabetes, Princess Margaret Hospital for Children, Perth, Western Australia, Australia.
Jan M FairchildEndocrinology and Diabetes Centre, Women's and Children's Hospital, Adelaide, South Australia, Australia.
Christel HendrieckxSchool of Psychology, Deakin University, Geelong, Victoria, Australia.
D Jane Holmes-WalkerDepartment of Diabetes and Endocrinology, Westmead Hospital, Sydney, New South Wales, Australia.
Jodie C HorsburghDepartment of Endocrinology and Diabetes, St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.
Alicia J JenkinsDepartment of Medicine, University of Melbourne, Melbourne, Victoria, Australia.
Joey KayeDepartment of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.
Anthony C KeechNHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.
Bruce R KingDepartment of Endocrinology and Diabetes, John Hunter Children's Hospital, Newcastle, New South Wales, Australia.
Kavita KumareswaranDepartment of Endocrinology and Diabetes, Alfred Hospital, Melbourne, Victoria, Australia.
Richard J MacIsaacDepartment of Medicine, University of Melbourne, Melbourne, Victoria, Australia.
Roland W McCallumDepartment of Diabetes and Endocrinology, Royal Hobart Hospital, Hobart, Tasmania, Australia.
Jennifer A NicholasDepartment of Endocrinology and Diabetes, Princess Margaret Hospital for Children, Perth, Western Australia, Australia.
Catriona SimsDepartment of Medicine, University of Melbourne, Melbourne, Victoria, Australia.
Jane SpeightSchool of Psychology, Deakin University, Geelong, Victoria, Australia.
Stephen N StranksSouthern Adelaide Diabetes and Endocrine Services, Flinders Medical Centre, Adelaide, South Australia, Australia.
Steven TrawleyAustralian Centre for Behavioural Research in Diabetes, Melbourne, Victoria, Australia.
Glenn M WardDepartment of Endocrinology and Diabetes, St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.
Sara VogrinDepartment of Medicine, University of Melbourne, Melbourne, Victoria, Australia.
Timothy W JonesDepartment of Endocrinology and Diabetes, Princess Margaret Hospital for Children, Perth, Western Australia, Australia.
David N O'NealDepartment of Medicine, University of Melbourne, Melbourne, Victoria, Australia.ORCID 0000-0002-0870-4032
The University of Melbourne · AUThe Kids Research Institute Australia · AUThe University of Sydney · AUBaker Heart and Diabetes Institute · AUDeakin University · AUDiabetes Australia · AUFlinders University · AUSt Vincent's Hospital Melbourne · AUAustralian Regenerative Medicine Institute · AUChildren's Hospital at Westmead · AUJohn Hunter Children's Hospital · AURoyal Children's Hospital · AURoyal Hobart Hospital · AUSir Charles Gairdner Hospital · AUThe Royal Melbourne Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionManual determination of insulin dosing largely fails to optimise glucose control in type 1 diabetes. Automated insulin delivery via closed-loop systems has improved glucose control in short-term studies. The objective of the present study is to determine the effectiveness of 6 months' closed-loop compared with manually determined insulin dosing on time-in-target glucose range in adults with type 1 diabetes. METHODS AND ANALYSIS: This open-label, seven-centre, randomised controlled parallel group clinical trial will compare home-based hybrid closed-loop versus standard diabetes therapy in Australia. Adults aged ≥25 years with type 1 diabetes using intensive insulin therapy (via multiple daily injections or insulin pump, total enrolment target n=120) will undertake a run-in period including diabetes and carbohydrate-counting education, clinical optimisation and baseline data collection. Participants will then be randomised 1:1 either to 26 weeks of MiniMed 670G hybrid closed-loop system therapy (Medtronic, Northridge, CA, USA) or continuation of their current diabetes therapy. The hybrid closed-loop system delivers insulin automatically to address basal requirements and correct to target glucose level, while bolus doses for meals require user initiation and carbohydrate estimation. Analysis will be intention to treat, with the primary outcome time in continuous glucose monitoring (CGM) target range (3.9-10.0 mmol/L) during the final 3 weeks of intervention. Secondary outcomes include: other CGM parameters, HbA ETHICS AND DISSEMINATION: The study has Human Research Ethics Committee approval. The study will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. Results will be disseminated at scientific conferences and via peer-reviewed publications. TRIAL REGISTRATION NUMBER: ACTRN12617000520336; Pre-results.

Indexed as

Insulin Infusion SystemsAdultAustraliaBlood GlucoseBlood Glucose Self-MonitoringDiabetes Mellitus, Type 1Glycated HemoglobinHome Care ServicesHumansHypoglycemiaHypoglycemic AgentsInsulinMulticenter Studies as TopicProspective StudiesQuality of LifeRandomized Controlled Trials as TopicBlood GlucoseGlycated HemoglobinHypoglycemic AgentsInsulinadultclosed looptype 1 diabetes

Identifiers

PMID29886443
PMCPMC6009467
OpenAlexW2806330283

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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 Socratic graph.