Literature DB >> 20144420

Blood glucose controller for neonatal intensive care: virtual trials development and first clinical trials.

Aaron Le Compte1, J Geoffrey Chase, Adrienne Lynn, Chris Hann, Geoffrey Shaw, Xing-Wei Wong, Jessica Lin.   

Abstract

BACKGROUND: Premature neonates often experience hyperglycemia, which has been linked to worsened outcomes. Insulin therapy can assist in controlling blood glucose (BG) levels. However, a reliable, robust control protocol is required to avoid hypoglycemia and to ensure that clinically important nutrition goals are met.
METHODS: This study presents an adaptive, model-based predictive controller designed to incorporate the unique metabolic state of the neonate. Controller performance was tested and refined in virtual trials on a 25-patient retrospective cohort. The effects of measurement frequency and BG sensor error were evaluated. A stochastic model of insulin sensitivity was used in control to provide a guaranteed maximum 4% risk of BG < 72 mg/dl to protect against hypoglycemia as well as account for patient variability over 1-3 h intervals when determining the intervention. The resulting controller is demonstrated in two 24 h clinical neonatal pilot trials at Christchurch Women's Hospital.
RESULTS: Time in the 72-126 mg/dl BG band was increased by 103-161% compared to retrospective clinical control for virtual trials of the controller, with fewer hypoglycemic measurements. Controllers were robust to BG sensor errors. The model-based controller maintained glycemia to a tight target control range and accounted for interpatient variability in patient glycemic response despite using more insulin than the retrospective case, illustrating a further measure of controller robustness. Pilot clinical trials demonstrated initial safety and efficacy of the control method.
CONCLUSIONS: A controller was developed that made optimum use of the very limited available BG measurements in the neonatal intensive care unit and provided robustness against BG sensor error and longer BG measurement intervals. It used more insulin than typical sliding scale approaches or retrospective hospital control. The potential advantages of a model-based approach demonstrated in simulation were applied to initial clinical trials. 2009 Diabetes Technology Society.

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Year:  2009        PMID: 20144420      PMCID: PMC2769904          DOI: 10.1177/193229680900300510

Source DB:  PubMed          Journal:  J Diabetes Sci Technol        ISSN: 1932-2968


  71 in total

1.  Integral-based parameter identification for long-term dynamic verification of a glucose-insulin system model.

Authors:  Christopher E Hann; J Geoffrey Chase; Jessica Lin; Thomas Lotz; Carmen V Doran; Geoffrey M Shaw
Journal:  Comput Methods Programs Biomed       Date:  2005-03       Impact factor: 5.428

2.  Adverse neurodevelopmental outcome of moderate neonatal hypoglycaemia.

Authors:  A Lucas; R Morley; T J Cole
Journal:  BMJ       Date:  1988-11-19

Review 3.  Glucose homeostasis in the micropremie.

Authors:  H M Farrag; R M Cowett
Journal:  Clin Perinatol       Date:  2000-03       Impact factor: 3.430

4.  Continuous insulin infusion in hyperglycaemic extremely-low- birth-weight neonates.

Authors:  Sze May Ng; Judith E May; Anthony J B Emmerson
Journal:  Biol Neonate       Date:  2005-02-04

5.  Blood volume assessment with hemoglobin subtype analysis in preterm infants.

Authors:  Jaana A Leipälä; Marjo Talme; Juha Viitala; Ursula Turpeinen; Vineta Fellman
Journal:  Biol Neonate       Date:  2003

6.  Role of glucose in the regulation of endogenous glucose production in the human newborn.

Authors:  S C Kalhan; A Oliven; K C King; C Lucero
Journal:  Pediatr Res       Date:  1986-01       Impact factor: 3.756

7.  Early elective insulin therapy can reduce hyperglycemia and increase insulin-like growth factor-I levels in very low birth weight infants.

Authors:  Kathryn Beardsall; Amanda L Ogilvy-Stuart; Jan Frystyk; Jian-Wen Chen; Mike Thompson; Jag Ahluwalia; Ken K Ong; David B Dunger
Journal:  J Pediatr       Date:  2007-08-10       Impact factor: 4.406

8.  Effect of intensive insulin therapy on insulin sensitivity in the critically ill.

Authors:  Lies Langouche; Sarah Vander Perre; Pieter J Wouters; André D'Hoore; Troels Krarup Hansen; Greet Van den Berghe
Journal:  J Clin Endocrinol Metab       Date:  2007-07-31       Impact factor: 5.958

9.  Continuous infusion of insulin in hyperglycemic low-birth weight infants receiving parenteral nutrition with and without lipid emulsion.

Authors:  K S Kanarek; M L Santeiro; J I Malone
Journal:  JPEN J Parenter Enteral Nutr       Date:  1991 Jul-Aug       Impact factor: 4.016

10.  Survey of the management of neonatal hyperglycaemia in Australasia.

Authors:  Jane M Alsweiler; Carl A Kuschel; Frank H Bloomfield
Journal:  J Paediatr Child Health       Date:  2007-06-29       Impact factor: 1.954

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  20 in total

1.  Stochastic targeted (STAR) glycemic control: design, safety, and performance.

Authors:  Alicia Evans; Aaron Le Compte; Chia-Siong Tan; Logan Ward; James Steel; Christopher G Pretty; Sophie Penning; Fatanah Suhaimi; Geoffrey M Shaw; Thomas Desaive; J Geoffrey Chase
Journal:  J Diabetes Sci Technol       Date:  2012-01-01

2.  Interface design and human factors considerations for model-based tight glycemic control in critical care.

Authors:  Logan Ward; James Steel; Aaron Le Compte; Alicia Evans; Chia-Siong Tan; Sophie Penning; Geoffrey M Shaw; Thomas Desaive; J Geoffrey Chase
Journal:  J Diabetes Sci Technol       Date:  2012-01-01

3.  Data entry errors and design for model-based tight glycemic control in critical care.

Authors:  Logan Ward; James Steel; Aaron Le Compte; Alicia Evans; Chia-Siong Tan; Sophie Penning; Geoffrey M Shaw; Thomas Desaive; J Geoffrey Chase
Journal:  J Diabetes Sci Technol       Date:  2012-01-01

4.  Progress in development of an artificial pancreas.

Authors:  David C Klonoff; Claudio Cobelli; Boris Kovatchev; Howard C Zisser
Journal:  J Diabetes Sci Technol       Date:  2009-09-01

5.  What makes tight glycemic control tight? The impact of variability and nutrition in two clinical studies.

Authors:  Fatanah Suhaimi; Aaron Le Compte; Jean-Charles Preiser; Geoffrey M Shaw; Paul Massion; Regis Radermecker; Christopher G Pretty; Jessica Lin; Thomas Desaive; J Geoffrey Chase
Journal:  J Diabetes Sci Technol       Date:  2010-03-01

Review 6.  On the problem of patient-specific endogenous glucose production in neonates on stochastic targeted glycemic control.

Authors:  Jennifer L Dickson; James N Hewett; Cameron A Gunn; Adrienne Lynn; Geoffrey M Shaw; J Geoffrey Chase
Journal:  J Diabetes Sci Technol       Date:  2013-07-01

7.  Nasogastric aspiration as an indicator for feed absorption in model-based glycemic control in neonatal intensive care.

Authors:  Cameron A Gunn; Jennifer L Dickson; James N Hewett; Adrienne Lynn; Hamish J Rose; Sooji H Clarkson; Geoffrey M Shaw; J Geoffrey Chase
Journal:  J Diabetes Sci Technol       Date:  2013-05-01

8.  Variability of insulin sensitivity during the first 4 days of critical illness: implications for tight glycemic control.

Authors:  Christopher G Pretty; Aaron J Le Compte; J Geoffrey Chase; Geoffrey M Shaw; Jean-Charles Preiser; Sophie Penning; Thomas Desaive
Journal:  Ann Intensive Care       Date:  2012-06-15       Impact factor: 6.925

9.  Pilot study of a model-based approach to blood glucose control in very-low-birthweight neonates.

Authors:  Aaron J Le Compte; Adrienne M Lynn; Jessica Lin; Christopher G Pretty; Geoffrey M Shaw; J Geoffrey Chase
Journal:  BMC Pediatr       Date:  2012-08-07       Impact factor: 2.125

10.  Using stochastic modelling to identify unusual continuous glucose monitor measurements and behaviour, in newborn infants.

Authors:  Matthew Signal; Aaron Le Compte; Deborah L Harris; Phil J Weston; Jane E Harding; J Geoffrey Chase
Journal:  Biomed Eng Online       Date:  2012-08-06       Impact factor: 2.819

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