Evidence map›Paper›PMID 22965294›Full record

Trial reportDiabetologia2012

The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomised controlled trial.

T Battelino, I Conget, B Olsen, I Schütz-Fuhrmann, E Hommel, R Hoogma, U Schierloh, N Sulli, J Bolinder, SWITCH Study Group

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetologia, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02092051 (A Randomized Trial of the Effect of Continuous Glucose Monitoring), which is not on this map. Cited by 215 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
215citing papers in PubMed, 8 pooled it
16.0field-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.

NCT02092051 nacompletednot on this mapstarted 2014, after this paper: background citation

A Randomized Trial of the Effect of Continuous Glucose Monitoring (CGM) in Individuals With Type 1 Diabetes Treated With Multiple Daily Insulin Injections (MDI)

TypeinterventionalSponsorVastra Gotaland RegionRan2014 to 2016Enrolled161ConditionsDiabetes Mellitus, Type 1ArmsContinuous glucose monitoring with DexCom G4 platina
3 · Its place in the literature

Who cites it

215 citing papers in PubMed, 8 syntheses or guidelines pooled it, 487 citations in OpenAlex.

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155 more citing papers are in PubMed but not listed here.

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

10 authors at 5 institutions in 8 countries.

T BattelinoUMC-University Children's Hospital, Faculty of Medicine, University of Ljubljana, Bohoričeva 20, Ljubljana, Slovenia. tadej.battelino@mf.uni-lj.si
I Conget
B Olsen
I Schütz-Fuhrmann
E Hommel
R Hoogma
U Schierloh
N Sulli
J Bolinder
SWITCH Study Group
Centre Hospitalier de Luxembourg · LUGlostrup Hospital · DKKarolinska University Hospital · SESteno Diabetes Centers · DKUniversity of Ljubljana · SI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aims/hypothesisThe aim of this multicentre, randomised, controlled crossover study was to determine the efficacy of adding continuous glucose monitoring (CGM) to insulin pump therapy (CSII) in type 1 diabetes.

methodsChildren and adults (n = 153) on CSII with HbA(1c) 7.5-9.5% (58.5-80.3 mmol/mol) were randomised to (CGM) a Sensor On or Sensor Off arm for 6 months. After 4 months' washout, participants crossed over to the other arm for 6 months. Paediatric and adult participants were separately electronically randomised through the case report form according to a predefined randomisation sequence in eight secondary and tertiary centres. The primary outcome was the difference in HbA(1c) levels between arms after 6 months.

resultsSeventy-seven participants were randomised to the On/Off sequence and 76 to the Off/On sequence; all were included in the primary analysis. The mean difference in HbA(1c) was -0.43% (-4.74 mmol/mol) in favour of the Sensor On arm (8.04% [64.34 mmol/mol] vs 8.47% [69.08 mmol/mol]; 95% CI -0.32%, -0.55% [-3.50, -6.01 mmol/mol]; p < 0.001). Following cessation of glucose sensing, HbA(1c) reverted to baseline levels. Less time was spent with sensor glucose <3.9 mmol/l during the Sensor On arm than in the Sensor Off arm (19 vs 31 min/day; p = 0.009). The mean number of daily boluses increased in the Sensor On arm (6.8 ± 2.5 vs 5.8 ± 1.9, p < 0.0001), together with the frequency of use of the temporary basal rate (0.75 ± 1.11 vs 0.26 ± 0.47, p < 0.0001) and manual insulin suspend (0.91 ± 1.25 vs 0.70 ± 0.75, p < 0.018) functions. Four vs two events of severe hypoglycaemia occurred in the Sensor On and Sensor Off arm, respectively (p = 0.40). CONCLUSIONS/

interpretationContinuous glucose monitoring was associated with decreased HbA(1c) levels and time spent in hypoglycaemia in individuals with type 1 diabetes using CSII. More frequent self-adjustments of insulin therapy may have contributed to these effects.

Indexed as

Insulin Infusion SystemsAdolescentAdultAgedBiosensing TechniquesBlood GlucoseBlood Glucose Self-MonitoringChildCross-Over StudiesDiabetes Mellitus, Type 1FemaleHumansHyperglycemiaHypoglycemic AgentsInsulinMaleBlood GlucoseHypoglycemic AgentsInsulin

Identifiers

PMID22965294
PMCPMC3483098
OpenAlexW2075474575

What OpenQuestion holds

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LicenceCC BY-NC
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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.