Evidence map›Paper›PMID 28540756›Full record

ArticleJournal of diabetes science and technology2017

Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Is It Safe?

Alan R Shapiro

3 registry-linked trialsAbstract read
In one paragraph

Article in Journal of diabetes science and technology, 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 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
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.

NCT04102657 naunknown statusnot on this mapstarted 2019, after this paper: background citation

Blood Glucose Differences Between Left Arm and Right Arm Using a Continuous Glucose

TypeinterventionalSponsorUniversity of the PacificRan2019 to 2019Enrolled46ConditionsDiabetesArmsIntermittent Fasting, Free-Living Diet, Left Arm Exercise, Right Arm Exercise
NCT04790760 naunknown statusnot on this mapstarted 2021, after this paper: background citation

Glucose Differences Between the Left Arm and Right Arm in Diabetic Patients Using a Continuous Glucose Monitor

TypeinterventionalSponsorUniversity of the PacificRan2021 to 2022Enrolled10ConditionsDiabetesArmsSupplement Consumption, Continuous Glucose Monitors
NCT05849428 naunknown statusnot on this mapstarted 2023, after this paper: background citation

Blood Glucose Differences Between Left Arm and Right Arm in Patients With Type 1 or Type 2 Diabetes Using a Continuous Glucose Monitor

TypeinterventionalSponsorUniversity of the PacificRan2023 to 2024Enrolled10ConditionsType 1 Diabetes, Type 2 DiabetesArmsFreestyle Libre 3
3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Trial
  2. Article
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  4. Article
  5. Review
  6. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

1 author.

Alan R Shapiro1 Department of Medicine, NYU School of Medicine, New York, NY, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

With the increasing accuracy of continuous glucose monitors (CGM) have come calls for the Food and Drug Administration (FDA) to label these devices as safe for nonadjunctive dosing of insulin. However, there is evidence that these devices are subject to sporadic, unpredictable, large errors. A text analysis of reports to the FDA MAUDE database since 2015 reveals over 25 000 complaints of CGM sensor inaccuracy, with instances directly leading to serious outcomes. These new data were not considered at a recent FDA Advisory Panel meeting that voted to approve Dexcom G5 relabeling for nonadjunctive use. Social media is another source of surveillance data providing evidence of large CGM inaccuracies in real-world use. We need to improve safety procedures, not remove them. CGMs offer unique information and alerts for managing diabetes, but the issue is not whether they are better than other approaches to monitoring glucose, but how they can be best used in conjunction with devices that offer the confirmatory readings needed for patient safety.

Indexed as

Blood Glucose Self-MonitoringDiabetes MellitusHumansHypoglycemic AgentsInsulinMonitoring, PhysiologicHypoglycemic AgentsInsulinCGM accuracycontinuous glucose monitorMAUDEnonadjunctive claimSMBGtext mining

Identifiers

PMID28540756
PMCPMC5588827

What Socratic holds

Textmetadata
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 Socratic graph.