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Sensor Life and Overnight Closed Loop: A Randomized Clinical Trial.

Martin Tauschmann1,2, Janet M Allen1,2, Malgorzata E Wilinska1,2

  • 11 Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.

Journal of Diabetes Science and Technology
|November 13, 2016
PubMed
Summary
This summary is machine-generated.

Closed-loop (CL) insulin delivery systems perform comparably overnight, regardless of continuous glucose monitor (CGM) sensor age. The model predictive control algorithm effectively manages glucose despite initial sensor inaccuracies.

Keywords:
artificial pancreasclosed loopcontinuous glucose monitoringsensor accuracysensor life

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Area of Science:

  • Endocrinology
  • Biomedical Engineering
  • Diabetes Technology

Background:

  • Closed-loop (CL) systems utilize continuous glucose monitor (CGM) data for automated insulin delivery.
  • CGM accuracy is known to decrease with sensor age, particularly on the first day of use.
  • This study investigated the impact of CGM sensor age on overnight CL system performance.

Purpose of the Study:

  • To evaluate the efficacy of overnight closed-loop (CL) insulin delivery based on continuous glucose monitor (CGM) sensor data from day 1 versus day 3-4 of sensor use.
  • To determine if CGM sensor accuracy variations affect CL system performance in adolescents with type 1 diabetes.

Main Methods:

  • An open-label, randomized, crossover pilot study was conducted with 12 adolescents using insulin pumps.
  • Participants underwent two overnight CL sessions: one starting on sensor day 1 and another on sensor day 3-4.
  • A model predictive control algorithm guided automated insulin delivery, with plasma glucose levels monitored regularly.

Main Results:

  • Overnight CL performance was comparable between sensor day 1 and day 3-4, with similar time in target glucose range (58% vs. 56%, P=.34).
  • No significant differences were observed in mean plasma glucose, time above 8.0 mmol/l, or time below 3.9 mmol/l between the two sensor age groups.
  • Mean absolute relative difference for CGM accuracy was higher on day 1 (19.8%) compared to day 3-4 (13.7%), indicating reduced accuracy early in sensor life.

Conclusions:

  • Overnight closed-loop glucose control is effective and comparable whether initiated on the first day or later days of CGM sensor use.
  • The model predictive control algorithm demonstrates robustness in mitigating the impact of sensor inaccuracies on glucose management.
  • These findings suggest that CL systems can provide reliable glucose control even with newer sensors exhibiting lower accuracy.