Evidence map›Paper›PMID 19444330›Full record

ArticleJournal of diabetes science and technology2009

In silico preclinical trials: a proof of concept in closed-loop control of type 1 diabetes.

Boris P Kovatchev, Marc Breton, Chiara Dalla Man, Claudio Cobelli

4 registry-linked trialsOpen access · bronzeAbstract read
In one paragraph

Article in Journal of diabetes science and technology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 245 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
245citing 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.

NCT01534013 nacompletednot on this mapstarted 2011, after this paper: background citation

Clinical Assessment of a Closed-loop Insulin Delivery System

TypeinterventionalSponsorImperial College LondonRan2011 to 2018Enrolled23ConditionsType 1 Diabetes MellitusArmsThe Imperial College Closed-Loop Insulin Delivery System, Open loop
NCT03186300 nacompletednot on this mapstarted 2017, after this paper: background citation

Patient Empowerment Through Predictive Personalised Decision Support (PEPPER)

TypeinterventionalSponsorInstitut d'Investigació Biomèdica de Girona Dr. Josep TruetaRan2017 to 2018Enrolled8ConditionsDiabetes Mellitus, Type 1ArmsPEPPER system
NCT03740698 naterminatednot on this mapstarted 2021, after this paper: background citation

The Bio-Inspired Artificial Pancreas for the Home

TypeinterventionalSponsorImperial College LondonRan2021 to 2022Enrolled8ConditionsDiabetes Mellitus, Type 1ArmsBiAP, ABC4D
NCT03849755 nacompletednot on this mapstarted 2018, after this paper: background citation

Patient Empowerment Through Predictive Personalised Decision Support(PEPPER)-Validation Study.

TypeinterventionalSponsorInstitut d'Investigació Biomèdica de Girona Dr. Josep TruetaRan2018 to 2019Enrolled58ConditionsDiabetes Mellitus, Type 1ArmsPEPPER system
3 · Its place in the literature

Who cites it

245 citing papers in PubMed, 1 synthesis or guideline pooled it, 743 citations in OpenAlex.

  1. Pooled it
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  16. AI-powered in silico twins: redefining precision medicine through simulation, personalization, and predictive healthcare.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2025
    Review
  17. Modeling the effect of glucagon on endogenous glucose production in healthy individuals under meal-like conditions.American journal of physiology. Regulatory, integrative and comparative physiology · 2025
    Article
  18. Review
  19. Smart closed-loop drug delivery systems.Nature reviews bioengineering · 2025
    Article
  20. Article

185 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

4 authors at 2 institutions in 2 countries.

Boris P KovatchevUniversity of Virginia, Charlottesville, Virginia 22908-4888, USA. boris@virginia.edu
Marc Breton
Chiara Dalla Man
Claudio Cobelli
University of Padua · ITUniversity of Virginia · US

Funding

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
NIDDK NIH HHS R01 DK051562NIDDK NIH HHS R01 DK 51562
6 · The paper itself

Abstract

Arguably, a minimally invasive system using subcutaneous (s.c.) continuous glucose monitoring (CGM) and s.c. insulin delivery via insulin pump would be a most feasible step to closed-loop control in type 1 diabetes mellitus (T1DM). Consequently, diabetes technology is focusing on developing an artificial pancreas using control algorithms to link CGM with s.c. insulin delivery. The future development of the artificial pancreas will be greatly accelerated by employing mathematical modeling and computer simulation. Realistic computer simulation is capable of providing invaluable information about the safety and the limitations of closed-loop control algorithms, guiding clinical studies, and out-ruling ineffective control scenarios in a cost-effective manner. Thus computer simulation testing of closed-loop control algorithms is regarded as a prerequisite to clinical trials of the artificial pancreas. In this paper, we present a system for in silico testing of control algorithms that has three principal components: (1) a large cohort of n=300 simulated "subjects" (n=100 adults, 100 adolescents, and 100 children) based on real individuals' data and spanning the observed variability of key metabolic parameters in the general population of people with T1DM; (2) a simulator of CGM sensor errors representative of Freestyle Navigator™, Guardian RT, or Dexcom™ STS™, 7-day sensor; and (3) a simulator of discrete s.c. insulin delivery via OmniPod Insulin Management System or Deltec Cozmo(®) insulin pump. The system has been shown to represent adequate glucose fluctuations in T1DM observed during meal challenges, and has been accepted by the Food and Drug Administration as a substitute to animal trials in the preclinical testing of closed-loop control strategies.

Indexed as

AlgorithmsComputer SimulationAdolescentAdultBlood GlucoseBlood Glucose Self-MonitoringChildDiabetes Mellitus, Type 1Drug Evaluation, PreclinicalGlucoseHumansInsulin Infusion SystemsBlood GlucoseGlucosecomputer simulationdiabetes controlmodeling

Identifiers

PMID19444330
PMCPMC2681269
OpenAlexW2167160009

What OpenQuestion holds

Textmetadata
LicenceTDM
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.