Evidence map›Paper›PMID 22688340›Full record

Trial reportDiabetes2012

Fully integrated artificial pancreas in type 1 diabetes: modular closed-loop glucose control maintains near normoglycemia.

Marc Breton, Anne Farret, Daniela Bruttomesso, Stacey Anderson, Lalo Magni, Stephen Patek, Chiara Dalla Man, Jerome Place, Susan Demartini, Simone Del Favero and 11 more

3 registry-linked trialsOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, 2012. 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 135 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
135citing papers in PubMed, 1 pooled it
26.4field-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.

NCT01390259 nacompletednot on this map

Hypoglycemia Prevention After Exercise in Adolescent T1DM Patients Using a Control to Range System

TypeinterventionalSponsorUniversity of VirginiaRan2010 to 2011Enrolled11ConditionsType 1 Diabetes MellitusArmsOpen-Loop, Closed-Loop
NCT01418703 nacompletednot on this map

Feasibility Study of a Modular Control to Range System in T1DM

TypeinterventionalSponsorUniversity of VirginiaRan2009 to 2010Enrolled38ConditionsType 1 Diabetes MellitusArmsClosed Loop Control (CLC), Open Loop
NCT05736263 naunknown statusnot on this mapstarted 2023, after this paper: background citation

Setting a New Algorithm For the Management of Exercise-induced Glycemic Variations in Patients With Type 1 Diabetes in Intensive Therapy With Hybrid Closed-loop Systems

TypeinterventionalSponsorUniversity of Roma La SapienzaRan2023 to 2024Enrolled50ConditionsType 1 Diabetes, ExerciseArmsModerate intensity exercise, High intensity interval exercise, Combined exercise, Resistance exercise
3 · Its place in the literature

Who cites it

135 citing papers in PubMed, 1 synthesis or guideline pooled it, 308 citations in OpenAlex.

  1. Pooled it
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  4. Psychosocial Impact of the Bionic Pancreas During Summer Camp.Journal of diabetes science and technology · 2016
    Trial
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  6. Home Use of an Artificial Beta Cell in Type 1 Diabetes.The New England journal of medicine · 2015
    Trial
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  10. Trial
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  17. An integrated multivariable artificial pancreas control system.Journal of diabetes science and technology · 2014
    Trial
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75 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 7 institutions in 3 countries.

Marc BretonUniversity of Virginia, Center for Diabetes Technology, Charlottesville, Virginia, USA. mb6nt@virginia.edu
Anne Farret
Daniela Bruttomesso
Stacey Anderson
Lalo Magni
Stephen Patek
Chiara Dalla Man
Jerome Place
Susan Demartini
Simone Del Favero
Chiara Toffanin
Colleen Hughes-Karvetski
Eyal Dassau
Howard Zisser
Francis J Doyle
Giuseppe De Nicolao
Angelo Avogaro
Claudio Cobelli
Eric Renard
Boris Kovatchev
International Artificial Pancreas Study Group
University of Virginia · USUniversity of Padua · ITUniversity of California, Santa Barbara · USUniversity of Pavia · ITCentre Hospitalier Universitaire de Montpellier · FRCentre National de la Recherche Scientifique · FRInserm · FR

Funding

Personalized Fully-Automated Regulation and Co-Regulation of Type 1 Diabetes: A Foundation Biobehavioral ApproachR01DK085623 · NIDDK · UNIVERSITY OF VIRGINIA · PI SUE A BROWN, BORIS P KOVATCHEV · 2009 to 2026
$10.6M
Introduction of Heart Rate Monitoring to the Closed-Loop Control of T1DMR21DK085641 · NIDDK · UNIVERSITY OF VIRGINIA · PI BRETON, MARC D · 2009 to 2010
$421k
NIDDK NIH HHS 5-R21-DK-85641NIDDK NIH HHS R21 DK085641
6 · The paper itself

Abstract

Integrated closed-loop control (CLC), combining continuous glucose monitoring (CGM) with insulin pump (continuous subcutaneous insulin infusion [CSII]), known as artificial pancreas, can help optimize glycemic control in diabetes. We present a fundamental modular concept for CLC design, illustrated by clinical studies involving 11 adolescents and 27 adults at the Universities of Virginia, Padova, and Montpellier. We tested two modular CLC constructs: standard control to range (sCTR), designed to augment pump plus CGM by preventing extreme glucose excursions; and enhanced control to range (eCTR), designed to truly optimize control within near normoglycemia of 3.9-10 mmol/L. The CLC system was fully integrated using automated data transfer CGM→algorithm→CSII. All studies used randomized crossover design comparing CSII versus CLC during identical 22-h hospitalizations including meals, overnight rest, and 30-min exercise. sCTR increased significantly the time in near normoglycemia from 61 to 74%, simultaneously reducing hypoglycemia 2.7-fold. eCTR improved mean blood glucose from 7.73 to 6.68 mmol/L without increasing hypoglycemia, achieved 97% in near normoglycemia and 77% in tight glycemic control, and reduced variability overnight. In conclusion, sCTR and eCTR represent sequential steps toward automated CLC, preventing extremes (sCTR) and further optimizing control (eCTR). This approach inspires compelling new concepts: modular assembly, sequential deployment, testing, and clinical acceptance of custom-built CLC systems tailored to individual patient needs.

Indexed as

Insulin Infusion SystemsPancreas, ArtificialAdolescentAdultAlgorithmsAutomationBlood GlucoseComputer SimulationCross-Over StudiesDiabetes Mellitus, Type 1HumansHypoglycemic AgentsMiddle AgedBlood GlucoseHypoglycemic Agents

Identifiers

PMID22688340
PMCPMC3425406
OpenAlexW2145097544

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.