Evidence map›Paper›PMID 37668666›Full record

ArticleDiabetes technology & therapeutics2023

Testing the Real-World Accuracy of the Dexcom G6 Pro CGM During the Insulin-Only Bionic Pancreas Pivotal Trial.

Martin Chase Marak, Peter Calhoun, Edward R Damiano, Steven J Russell, Katrina J Ruedy, Roy W Beck

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in Diabetes technology & therapeutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04200313 (The Insulin-Only Bionic Pancreas Pivotal Trial), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.6field-weighted citation impact, top 15% 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.

NCT04200313 nacompletednot on this map

The Insulin-Only Bionic Pancreas Pivotal Trial: Testing the iLet in Adults and Children With Type 1 Diabetes

TypeinterventionalSponsorJaeb Center for Health ResearchRan2020 to 2022Enrolled440ConditionsDiabetes Mellitus, Type 1 Diabetes, Diabetes Mellitus, Type 1ArmsBionic Pancreas (BP) with Aspart or Lispro, Bionic Pancreas with Fiasp (BPFiasp), Usual Care (UC), BP Guidance Insulin Dosing
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Observational
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

6 authors at 2 institutions in 1 country.

Martin Chase MarakJaeb Center for Health Research, Tampa, Florida, USA.ORCID 0009-0008-0908-7911
Peter CalhounJaeb Center for Health Research, Tampa, Florida, USA.ORCID 0000-0002-5325-7200
Edward R DamianoBeta Bionics, Concord, Massachusetts, USA.
Steven J RussellBeta Bionics, Concord, Massachusetts, USA.
Katrina J RuedyJaeb Center for Health Research, Tampa, Florida, USA.
Roy W BeckJaeb Center for Health Research, Tampa, Florida, USA.ORCID 0000-0002-5194-8446
Jaeb Center for Health Research · USConcord Consortium · US

Funding

Final clinical studies for submission of a pre-market approval application to the FDA for a Bionic Pancreas that automates type 1 diabetes managementUC4DK108612 · NIDDK · BOSTON UNIVERSITY (CHARLES RIVER CAMPUS) · PI BECK, ROY W., DAMIANO, EDWARD · 2015 to 2016
$13.5M
NIDDK NIH HHS UC4 DK108612
6 · The paper itself

Abstract

Continuous glucose monitors (CGMs) have transformed the way people with type 1 diabetes can self-monitor glucose levels. Past studies have evaluated the accuracy of CGMs in clinic-based studies, but few have analyzed their accuracy in real-world settings. The Insulin-Only Bionic Pancreas Trial provided the opportunity to assess real-world accuracy of the blinded Dexcom G6 Pro sensor over the first 48-60 h of wear using a blood glucose meter (BGM) as a comparator for 1073 CGM-BGM pairs across 53 participants. The mean absolute relative difference (MARD) was 11.0% over a median period of 50 h (range 47-79 h). The MARD was 13.6% in the first 12 h, 10.5% in hours 12-24, and 10.1% after the first 24 h. These results are comparable with accuracy shown previously with laboratory-based measurements and provide real-world evidence of Dexcom G6 Pro accuracy, which improved after the first 12 h and then remained stable thereafter. Clinical Trial Registry: clinicaltrials.gov; NCT04200313.

Indexed as

Diabetes Mellitus, Type 1InsulinBionicsBlood GlucoseBlood Glucose Self-MonitoringHumansInsulin, Regular, HumanPancreasReproducibility of ResultsBlood GlucoseInsulinInsulin, Regular, HumanAccuracyBlood glucoseContinuous glucose monitorsDexcomType 1 diabetes

Identifiers

PMID37668666
PMCPMC10771867
OpenAlexW4386438003

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.