Evidence map›Paper›PMID 28137708›Full record

Trial reportArchives of disease in childhood2017

An alternative sensor-based method for glucose monitoring in children and young people with diabetes.

Julie Edge, Carlo Acerini, Fiona Campbell, Julian Hamilton-Shield, Chris Moudiotis, Shakeel Rahman, Tabitha Randell, Anne Smith, Nicola Trevelyan

3 registry-linked trialsOpen access · hybridAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Archives of disease in childhood, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 56 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 2 pooled it
16.5field-weighted citation impact, top 1% 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.

NCT02388815 nacompletednot on this map

Evaluation of the Accuracy of the Abbott Sensor Based Glucose Monitoring System - Paediatric Label Extension Study (CE)

TypeinterventionalSponsorAbbott Diabetes CareRan2015 to 2015Enrolled89ConditionsDiabetes MellitusArmsFreeStyle Libre Flash Glucose Monitoring System
NCT04275479 terminatednot on this mapstarted 2020, after this paper: background citation

Endocrine Diabetes Screening in Patients With Shwachman-Diamond Syndrome DIABETES/ ENDOCRINE SURVEILLANCE IN SDS

TypeobservationalSponsorWashington University School of MedicineRan2020 to 2022Enrolled11ConditionsShwachman-Diamond SyndromeArmsOral Glucose Tolerance Test, Modified Oral Glucose Tolerance Test, Modified Mixed Meal Tolerance Test, Continuous Glucose Monitor, Food Diary
NCT05597293 nacompletednot on this mapstarted 2023, after this paper: background citation

Effect of Introduction of FreeStyle Libre Monitoring on Glycaemic Control in People with Type 2 Diabetes Mellitus (T2DM)

TypeinterventionalSponsorUniversity of HullRan2023 to 2024Enrolled40ConditionsType2diabetesArmsGlucose monitoring using FreeStyle Libre 2, Glucose monitoring using FreeStyle Libre pro iQ
3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 2 syntheses or guidelines pooled it, 153 citations in OpenAlex.

  1. Guideline
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  3. Use of Freestyle Libre 2.0 in children with type 1 diabetes mellitus and elevated HbADiabetic medicine : a journal of the British Diabetic Association · 2025
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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 8 institutions in 1 country.

Julie EdgeDepartment of Paediatric Endocrinology and Diabetes, Oxford Children's Hospital, Oxford, UK.
Carlo AceriniThe Weston Centre for Childhood & Adolescent Diabetes and Endocrinology, Addenbrooke's Hospital, Cambridge, UK.
Fiona CampbellMulti Speciality Out-Patients Department, Leeds Children's Hospital, Leeds Teaching Hospitals, Leeds, UK.
Julian Hamilton-ShieldDepartment of Paediatric Diabetes and Endocrinology, Bristol Royal Hospital for Children, Bristol, UK.
Chris MoudiotisDepartment of Paediatric Diabetes and Endocrinology, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.
Shakeel RahmanDepartment of Paediatric Diabetes and Endocrinology, Harrogate District Hospital, Harrogate, UK.
Tabitha RandellDepartment of Paediatric Diabetes and Endocrinology, Nottingham University Hospitals NHS Trust, Nottingham, UK.
Anne SmithDepartment of Paediatric Diabetes and Endocrinology, Northampton General Hospital, Northampton, UK.
Nicola TrevelyanSouthampton Children's Hospital, Southampton General Hospital, Southampton, UK.
Addenbrooke's Hospital · GBBristol Royal Hospital for Children · GBHarrogate District Hospital · GBLeeds Teaching Hospitals NHS Trust · GBNorthampton General Hospital · GBNottingham University Hospitals NHS Trust · GBRoyal Devon & Exeter NHS Foundation Trust · GBSouthampton General Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo determine accuracy, safety and acceptability of the FreeStyle Libre Flash Glucose Monitoring System in the paediatric population. DESIGN, SETTING AND PATIENTS: Eighty-nine study participants, aged 4-17 years, with type 1 diabetes were enrolled across 9 diabetes centres in the UK. A factory calibrated sensor was inserted on the back of the upper arm and used for up to 14 days. Sensor glucose measurements were compared with capillary blood glucose (BG) measurements. Sensor results were masked to participants.

resultsClinical accuracy of sensor results versus BG results was demonstrated, with 83.8% of results in zone A and 99.4% of results in zones A and B of the consensus error grid. Overall mean absolute relative difference (MARD) was 13.9%. Sensor accuracy was unaffected by patient factors such as age, body weight, sex, method of insulin administration or time of use (day vs night). Participants were in the target glucose range (3.9-10.0 mmol/L) ∼50% of the time (mean 12.1 hours/day), with an average of 2.2 hours/day and 9.5 hours/day in hypoglycaemia and hyperglycaemia, respectively. Sensor application, wear/use of the device and comparison to self-monitoring of blood glucose were rated favourably by most participants/caregivers (84.3-100%). Five device related adverse events were reported across a range of participant ages.

conclusionsAccuracy, safety and user acceptability of the FreeStyle Libre System were demonstrated for the paediatric population. Accuracy of the system was unaffected by subject characteristics, making it suitable for a broad range of children and young people with diabetes. TRIAL REGISTRATION NUMBER: NCT02388815.

Indexed as

AdolescentBlood GlucoseBlood Glucose Self-MonitoringChildChild, PreschoolCircadian ClocksDiabetes Mellitus, Type 1Drug Administration ScheduleFemaleGlycated HemoglobinHumansHypoglycemic AgentsInsulinMalePatient Acceptance of Health CareBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinDiabetesGeneral PaediatricsMonitoringTechnology

Identifiers

PMID28137708
PMCPMC5466923
OpenAlexW2582199162

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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 OpenQuestion graph.