Evidence map›Paper›PMID 25003311›Full record

ArticleDiabetes technology & therapeutics2014

Multicenter closed-loop insulin delivery study points to challenges for keeping blood glucose in a safe range by a control algorithm in adults and adolescents with type 1 diabetes from various sites.

Howard Zisser, Eric Renard, Boris Kovatchev, Claudio Cobelli, Angelo Avogaro, Revital Nimri, Lalo Magni, Bruce A Buckingham, H Peter Chase, Francis J Doyle and 22 more

Erratum issuedOpen access · greenAbstract readMulticenter Study
In one paragraph

Article in Diabetes technology & therapeutics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
6.0field-weighted citation impact, top 3% 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

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 47 citations in OpenAlex.

  1. Pooled it
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  10. Diabetes Technology: Monitoring, Analytics, and Optimal Control.Cold Spring Harbor perspectives in medicine · 2019
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  20. Physical activity and type 1 diabetes: time for a rewire?Journal of diabetes science and technology · 2015
    Review
4 · The record

Corrections and comments

  • Erratum issued
    Correction.2015 · Vistenin, Roberto [corrected to Visentin, Roberto]
5 · Who and what money

Authors and funding

32 authors at 10 institutions in 5 countries.

Howard Zisser1 Sansum Diabetes Research Institute , Santa Barbara, California.
Eric Renard
Boris Kovatchev
Claudio Cobelli
Angelo Avogaro
Revital Nimri
Lalo Magni
Bruce A Buckingham
H Peter Chase
Francis J Doyle
John Lum
Peter Calhoun
Craig Kollman
Eyal Dassau
Anne Farret
Jerome Place
Marc Breton
Stacey M Anderson
Chiara Dalla Man
Simone Del Favero
Daniela Bruttomesso
Alessio Filippi
Rachele Scotton
Moshe Phillip
Eran Atlas
Ido Muller
Shahar Miller
Chiara Toffanin
Davide Martino Raimondo
Giuseppe De Nicolao
Roy W Beck
Control to Range Study Group
University of Padua · ITTel Aviv University · ILJaeb Center for Health Research · USUniversity of Pavia · ITCentre National de la Recherche Scientifique · FRUniversity of Virginia · USUniversity of California, Santa Barbara · USDiabetes Australia · AUSansum Diabetes Research Institute · USStanford University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Control to Range Study was a multinational artificial pancreas study designed to assess the time spent in the hypo- and hyperglycemic ranges in adults and adolescents with type 1 diabetes while under closed-loop control. The controller attempted to keep the glucose ranges between 70 and 180 mg/dL. A set of prespecified metrics was used to measure safety. RESEARCH DESIGN AND

methodsWe studied 53 individuals for approximately 22 h each during clinical research center admissions. Plasma glucose level was measured every 15-30 min (YSI clinical laboratory analyzer instrument [YSI, Inc., Yellow Springs, OH]). During the admission, subjects received three mixed meals (1 g of carbohydrate/kg of body weight; 100 g maximum) with meal announcement and automated insulin dosing by the controller.

resultsFor adults, the mean of subjects' mean glucose levels was 159 mg/dL, and mean percentage of values 71-180 mg/dL was 66% overall (59% daytime and 82% overnight). For adolescents, the mean of subjects' mean glucose levels was 166 mg/dL, and mean percentage of values in range was 62% overall (53% daytime and 82% overnight). Whereas prespecified criteria for safety were satisfied by both groups, they were met at the individual level in adults only for combined daytime/nighttime and for isolated nighttime. Two adults and six adolescents failed to meet the daytime criterion, largely because of postmeal hyperglycemia, and another adolescent failed to meet the nighttime criterion.

conclusionsThe control-to-range system performed as expected: faring better overnight than during the day and performing with variability between patients even after individualization based on patients' prior settings. The system had difficulty preventing postmeal excursions above target range.

Indexed as

Pancreas, ArtificialAdolescentAdultAlgorithmsBlood GlucoseBlood Glucose Self-MonitoringDiabetes Mellitus, Type 1Dietary CarbohydratesFemaleGlycated HemoglobinHumansHyperglycemiaHypoglycemiaHypoglycemic AgentsInsulinInsulin SecretionBlood GlucoseDietary CarbohydratesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulin

Identifiers

PMID25003311
PMCPMC4183913
OpenAlexW1505393224

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.