Evidence map›Paper›PMID 31109342›Full record

ArticleBMC endocrine disorders2019

Effect of 6 months' flash glucose monitoring in adolescents and young adults with type 1 diabetes and suboptimal glycaemic control: managing diabetes in a 'flash' randomised controlled trial protocol.

Sara E Boucher, Andrew R Gray, Martin de Bock, Esko J Wiltshire, Barbara C Galland, Paul A Tomlinson, Jenny Rayns, Karen E MacKenzie, Benjamin J Wheeler

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC endocrine disorders, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.8field-weighted citation impact, top 15% 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

8 citing papers in PubMed, 17 citations in OpenAlex.

  1. Trial
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  7. Assessing Diabetes Distress and Sleep Quality in Young Adults with Type 1 Diabetes Using FreeStyle Libre: A Prospective Cohort Study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020
    Article
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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

9 authors at 4 institutions in 1 country.

Sara E BoucherDepartment of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
Andrew R GrayCentre for Biostatistics, Division of Health Sciences, University of Otago, Dunedin, New Zealand.
Martin de BockDepartment of Paediatrics, University of Otago, Christchurch, New Zealand.
Esko J WiltshireDepartment of Paediatrics and Child Health, University of Otago Wellington, Wellington, New Zealand.
Barbara C GallandDepartment of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
Paul A TomlinsonPaediatric Department, Southern District Health Board, Invercargill, New Zealand.
Jenny RaynsEndocrinology Department, Southern District Health Board, Dunedin, New Zealand.
Karen E MacKenzieDepartment of Paediatrics, University of Otago, Christchurch, New Zealand.
Benjamin J WheelerDepartment of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand. ben.wheeler@otago.ac.nz.ORCID http://orcid.org/0000-0003-3348-5238
Southern District Health Board · NZUniversity of Otago · NZCanterbury District Health Board · NZCapital and Coast District Health Board · NZ

Funding

Cure Kids 3582
6 · The paper itself

Abstract

backgroundTeenagers and young adults with type 1 diabetes (T1D) experience significant burden managing this serious chronic condition and glycaemic control is at its unhealthiest during this life stage. Flash glucose monitoring (FGM) is a new technology that reduces the burden of glucose monitoring by easily and discreetly displaying glucose information when an interstitial glucose sensor worn on the upper arm is scanned with a handheld reader, as opposed to traditional capillary glucose sampling by finger prick (otherwise known as self-monitored blood glucose, SMBG). The effectiveness of this technology and impacts of its long-term use in youth with pre-existing suboptimal glycaemic control are unknown. This study therefore aims to investigate the effectiveness of FGM in addition to standard care in young people with T1D.

methodsThis is a two phase study programme including a multi-centre randomised, parallel-group study consisting of a 6-month comparison between SMBG and FGM, with an additional 6-month continuation phase. We will enrol adolescents with T1D aged 13-20 years (inclusive), with suboptimal glycaemic control (mean glycated haemoglobin (HbA1c) in past 6 months ≥75 mmol/mol [≥9%]). Participants will be randomly allocated (1:1) to FGM (FreeStyle Libre; intervention group) or to continue SMBG with capillary blood glucose testing (usual care group). All participants will continue other aspects of standard care with the study only providing the FreeStyle Libre. At 6 months, the control group will cross over to the intervention. The primary outcome is the between group difference in changes in HbA1c at 6 months. Additional outcomes include a range of psychosocial and health economic measures as well as FGM acceptability. DISCUSSION: >If improvements are found, this will further encourage steps towards integrating FGM into regular diabetes care for youth with unhealthy glycaemic control, with the expectation it will reduce daily diabetes management burden and improve short- and long-term health outcomes in this high-risk group.

trial registrationThis trial was registered with the Australian New Zealand Clinical Trials Registry on 5 March 2018 ( ACTRN12618000320257p ) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1205-5784).

Indexed as

Health Knowledge, Attitudes, PracticePatient Education as TopicAdolescentAdultBiomarkersBlood GlucoseBlood Glucose Self-MonitoringCase-Control StudiesDiabetes Mellitus, Type 1Disease ManagementFemaleFollow-Up StudiesGlycated HemoglobinHumansHypoglycemic AgentsMaleBiomarkersBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsAdolescentsFlash glucose monitoringFreeStyle libreGlucose monitoringGlycaemic controlIntermittent continuous glucose monitoringSelf-monitoring of blood glucoseType 1 diabetesYoung adults

Identifiers

PMID31109342
PMCPMC6528266
OpenAlexW2947699232

What OpenQuestion holds

Textmetadata
LicenceCC BY
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 OpenQuestion graph.