Evidence map›Paper›PMID 31332929›Full record

Trial reportDiabetes, obesity & metabolism2019

Performance of the Freestyle Libre flash glucose monitoring (flash GM) system in individuals with type 1 diabetes: A secondary outcome analysis of a randomized crossover trial.

Othmar Moser, Max L Eckstein, Olivia McCarthy, Rachel Deere, Jason Pitt, David M Williams, Jennifer Hayes, Harald Sourij, Stephen C Bain, Richard M Bracken

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 2 pooled it
7.5field-weighted citation impact, top 2% 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

38 citing papers in PubMed, 2 syntheses or guidelines pooled it, 73 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Flash glucose monitoring system in special situations.Archives of endocrinology and metabolism · 2022
    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

10 authors at 2 institutions in 2 countries.

Othmar MoserDiabetes Research Group, Medical School, Swansea University, Swansea, UK.ORCID 0000-0002-1661-0685
Max L EcksteinDiabetes Research Group, Medical School, Swansea University, Swansea, UK.
Olivia McCarthyDiabetes Research Group, Medical School, Swansea University, Swansea, UK.
Rachel DeereDiabetes Research Group, Medical School, Swansea University, Swansea, UK.
Jason PittDiabetes Research Group, Medical School, Swansea University, Swansea, UK.
David M WilliamsApplied Sport, Technology, Exercise and Medicine Research Centre (A-STEM), College of Engineering, Swansea University, Swansea, UK.
Jennifer HayesApplied Sport, Technology, Exercise and Medicine Research Centre (A-STEM), College of Engineering, Swansea University, Swansea, UK.
Harald SourijDivision of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.ORCID 0000-0003-3510-9594
Stephen C BainApplied Sport, Technology, Exercise and Medicine Research Centre (A-STEM), College of Engineering, Swansea University, Swansea, UK.ORCID 0000-0001-8519-4964
Richard M BrackenDiabetes Research Group, Medical School, Swansea University, Swansea, UK.ORCID 0000-0002-6986-6449
Swansea University · GBMedical University of Graz · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe efficacy of flash glucose monitoring (flash GM) systems has been demonstrated by improvements in glycaemia; however, during high rates of glucose flux, the performance of continuous glucose monitoring systems was impaired, as detailed in previous studies. This study aimed to determine the performance of the flash GM system during daily-life glycaemic challenges such as carbohydrate-rich meals, bolus insulin-induced glycaemic disturbances and acute physical exercise in individuals with type 1 diabetes. MATERIALS AND

methodsThis study comprised four randomized trial visits with alternating pre- and post-exercise bolus insulin doses. Throughout the four 14-hour inpatient phases, 19 participants received three carbohydrate-rich meals and performed moderate-intensity exercise. Venous blood glucose and capillary blood glucose during exercise was compared to interstitial glucose concentrations. Flash GM accuracy was assessed by median absolute relative difference (MARD) (interquartile range [IQR]) using the Bland-Altman method and Clark error grid, as well as according to guidelines for integrated CGM approvals (Class II-510(K)).

resultsThe overall MARD (IQR) during inpatient phases was 14.3% (6.9%-22.8%), during hypoglycaemia (≤3.9 mmol/L) was 31.6% (16.2%-46.8%), during euglycaemia (4.0 mmol/L - 9.9 mmol/L) was 16.0% (8.5%-24.0%) and during hyperglycaemia (≥10 mmol/L) was 9.4% (5.1%-15.7%). Overall Bland-Altman analysis showed a bias (95% LoA) of 1.26 mmol/L (-1.67 to 4.19 mmol/L). The overall MARD during acute exercise was 29.8% (17.5%-39.8%), during hypoglycaemia was 45.1% (35.2%-51.1%), during euglycaemia was 30.7% (18.7%-39.2%) and during hyperglycaemia was 16.3% (10.0%-22.8%).

conclusionFlash GM interstitial glucose readings were not sufficiently accurate within the hypoglycaemic range and during acute exercise and require confirmatory blood glucose measurements.

Indexed as

Diabetes Mellitus, Type 1AdultBlood GlucoseBlood Glucose Self-MonitoringCross-Over StudiesExerciseFemaleHumansMaleMiddle AgedReproducibility of ResultsYoung AdultBlood Glucosecontinuous glucose monitoring (CGM), exercise intervention, hypoglycaemia, type 1 diabetes

Identifiers

PMID31332929
PMCPMC6852439
OpenAlexW2962886675

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.