Evidence map›Paper›PMID 28143495›Full record

Trial reportBMC endocrine disorders2017

Self-monitoring of Blood Glucose in Non-Insulin Treated Type 2 Diabetes (The SMBG Study): study protocol for a randomised controlled trial.

Sharon Parsons, Stephen Luzio, Stephen Bain, John Harvey, Jillian McKenna, Atir Khan, Sam Rice, Alan Watkins, David R Owens

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC endocrine disorders, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.4field-weighted citation impact, top 18% 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

6 citing papers in PubMed, 15 citations in OpenAlex.

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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 3 institutions in 1 country.

Sharon ParsonsDiabetes Research Unit, Swansea University, Institute of Life Sciences, Singleton Park, Swansea, SA2 8PP, UK. S.N.Parsons@swansea.ac.uk.ORCID http://orcid.org/0000-0002-5841-8309
Stephen LuzioDiabetes Research Unit, Swansea University, Institute of Life Sciences, Singleton Park, Swansea, SA2 8PP, UK.
Stephen BainDiabetes Research Unit, Swansea University, Institute of Life Sciences, Singleton Park, Swansea, SA2 8PP, UK.
John HarveyDiabetes Centre, Wrexham Maelor Hospital, Betsi Cadwaladr University Health Board, Wrexham, UK.
Jillian McKennaDiabetes Research Unit, Swansea University, Institute of Life Sciences, Singleton Park, Swansea, SA2 8PP, UK.
Atir KhanDiabetes Centre, Glangwili Hosptial, Hywel Dda University Health Board, Carmarthen, UK.
Sam RiceDiabetes Centre, Prince Philip Hospital, Hywel Dda University Health Board, Llanelli, UK.
Alan WatkinsSwansea Trials Unit, Swansea University, Swansea, UK.
David R OwensDiabetes Research Unit, Swansea University, Institute of Life Sciences, Singleton Park, Swansea, SA2 8PP, UK.
Swansea University · GBHywel Dda University Health Board · GBBetsi Cadwaladr University Health Board · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe benefit of Self-monitoring of Blood Glucose (SMBG) in people with non-insulin treated type 2 diabetes remains unclear with inconsistent evidence from randomised controlled trials fuelling the continued debate. Lack of a consistent finding has been attributed to variations in study population and design, including the SMBG intervention. There is a growing consensus that structured SMBG, whereby the person with diabetes and health care provider are educated to detect patterns of glycaemic abnormality and take appropriate action according to the blood glucose profiles, can prove beneficial in terms of lowering HbA1c and improving overall well-being. Despite this, many national health agencies continue to issue guidelines restricting the use of SMBG in non-insulin treated type 2 diabetes.

methodsThe SMBG Study is a 12 month, multi-centre, randomised controlled trial in people with type 2 diabetes not on insulin therapy who have poor glycaemic control (HbA1c ≥58 mmol/mol / 7.5%). The participants will be randomised into three comparative groups: Group 1 will act as a control group and receive their usual diabetes care; Group 2 will undertake structured SMBG with clinical review every 3 months; Group 3 will undertake structured SMBG with additional monthly telecare support from a trained study nurse. A total of 450 participants will be recruited from 16 primary and secondary care sites across Wales and England. The primary outcome measure will be HbA1c at 12 months with secondary measures to include weight, BMI, total cholesterol and HbA1c levels at 3, 6, 9 and 12 months. Participant well-being and attitude towards SMBG will be monitored throughout the course of the study. Recruitment began in December 2012 with the last participant visit due in September 2016. DISCUSSION: This study will attempt to answer the question of whether structured SMBG provides any benefits to people with poorly controlled type 2 diabetes who are not being treated with insulin. The data will also clarify whether the telecare support provides additional value. The overall acceptability of SMBG as a tool for self-management will be assessed.

trial registrationUKCRN 12038 (Registered March 2012). ISRCTN21390608 (Retrospectively registered 15

Indexed as

AdolescentAdultAgedBiomarkersBlood GlucoseBlood Glucose Self-MonitoringClinical ProtocolsDiabetes Mellitus, Type 2FemaleFollow-Up StudiesGlycated HemoglobinHumansHypoglycemic AgentsMaleMiddle AgedMonitoring, PhysiologicBiomarkersBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulin naïveRandomised controlled trialStructured SMBGType 2 diabetes

Identifiers

PMID28143495
PMCPMC5286854
OpenAlexW2584361144

What OpenQuestion holds

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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.