Evidence map›Paper›PMID 21129332›Full record

ArticleJournal of diabetes science and technology2010

Multinational study of subcutaneous model-predictive closed-loop control in type 1 diabetes mellitus: summary of the results.

Boris Kovatchev, Claudio Cobelli, Eric Renard, Stacey Anderson, Marc Breton, Stephen Patek, William Clarke, Daniela Bruttomesso, Alberto Maran, Silvana Costa and 7 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter Study
In one paragraph

Article in Journal of diabetes science and technology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00977808 (Pilot Study of Closed-Loop Glucose Control in People With Type 1 Diabetes), which is not on this map. Cited by 75 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 1 pooled it
13.1field-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.

NCT00977808 nacompletednot on this map

Pilot Study of Closed-Loop Glucose Control in People With Type 1 Diabetes(BPK004)

TypeinterventionalSponsorUniversity of VirginiaRan2008 to 2009Enrolled12ConditionsType 1 DiabetesArmsClosed-Loop, Model Predictive Control (MPC), Open-Loop
3 · Its place in the literature

Who cites it

75 citing papers in PubMed, 1 synthesis or guideline pooled it, 198 citations in OpenAlex.

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15 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

17 authors at 5 institutions in 3 countries.

Boris KovatchevDepartment of Psychiatry and Neurobehavioral Sciences, University of Virginia, Charlottesville, Virginia 22908, USA. boris@virginia.edu
Claudio Cobelli
Eric Renard
Stacey Anderson
Marc Breton
Stephen Patek
William Clarke
Daniela Bruttomesso
Alberto Maran
Silvana Costa
Angelo Avogaro
Chiara Dalla Man
Andrea Facchinetti
Lalo Magni
Giuseppe De Nicolao
Jerome Place
Anne Farret
University of Padua · ITUniversity of Virginia · USCentre National de la Recherche Scientifique · FRUniversity of Pavia · ITUniversité de Montpellier · FR

Funding

ZACOPRIDE VS METOCLOPRAMIDE--EFFECT ON LOWER ESOPHAGEAL SPHINCTERM01RR000847 · NCRR · UNIVERSITY OF VIRGINIA CHARLOTTESVILLE · PI BRETON, MARC D · 1985 to 2010
$48.1M
Improving intensive insulin therapy through the personalization of data-driven decision support system to patients’ goals and preferences and its adaptation to long term health needsR01DK051562 · NIDDK · UNIVERSITY OF VIRGINIA CHARLOTTESVILLE · PI MARC D BRETON, Chiara Fabris · 1996 to 2026
$9.4M
NCRR NIH HHS M01 RR00847NIDDK NIH HHS R01 DK 51562
6 · The paper itself

Abstract

backgroundIn 2008-2009, the first multinational study was completed comparing closed-loop control (artificial pancreas) to state-of-the-art open-loop therapy in adults with type 1 diabetes mellitus (T1DM).

methodsThe design of the control algorithm was done entirely in silico, i.e., using computer simulation experiments with N=300 synthetic "subjects" with T1DM instead of traditional animal trials. The clinical experiments recruited 20 adults with T1DM at the Universities of Virginia (11); Padova, Italy (6); and Montpellier, France (3). Open-loop and closed-loop admission was scheduled 3-4 weeks apart, continued for 22 h (14.5 h of which were in closed loop), and used a continuous glucose monitor and an insulin pump. The only difference between the two sessions was that insulin dosing was performed by the patient under a physician's supervision during open loop, whereas insulin dosing was performed by a control algorithm during closed loop.

resultsIn silico design resulted in rapid (less than 6 months compared to years of animal trials) and cost-effective system development, testing, and regulatory approvals in the United States, Italy, and France. In the clinic, compared to open-loop, closed-loop control reduced nocturnal hypoglycemia (blood glucose below 3.9 mmol/liter) from 23 to 5 episodes (p<.01) and increased the amount of time spent overnight within the target range (3.9 to 7.8 mmol/liter) from 64% to 78% (p=.03).

conclusionsIn silico experiments can be used as viable alternatives to animal trials for the preclinical testing of insulin treatment strategies. Compared to open-loop treatment under identical conditions, closed-loop control improves the overnight regulation of diabetes.

Indexed as

Insulin Infusion SystemsPancreas, ArtificialAdolescentAdultAgedAlgorithmsBlood GlucoseChildComputer SimulationDiabetes Mellitus, Type 1Drug Dosage CalculationsFemaleFranceGlycated HemoglobinHumansHypoglycemiaBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulin

Identifiers

PMID21129332
PMCPMC3005047
OpenAlexW2134017961

What OpenQuestion 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 OpenQuestion graph.