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Related Concept Videos

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Randomized Controlled Trial of Mobile Closed-Loop Control.

Boris Kovatchev1, Stacey M Anderson2, Dan Raghinaru3

  • 1Center for Diabetes Technology, University of Virginia, Charlottesville, VA.

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|January 16, 2020
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Summary
This summary is machine-generated.

Mobile closed-loop control (CLC) significantly reduced time below target glucose levels compared to sensor-augmented pump (SAP) therapy in type 1 diabetes patients. This mobile CLC system demonstrated feasibility and potential usability benefits.

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Area of Science:

  • Endocrinology
  • Biomedical Engineering
  • Diabetes Technology

Background:

  • Type 1 diabetes management often involves continuous glucose monitoring and insulin pump therapy.
  • Closed-loop control (CLC) systems aim to automate glucose regulation.
  • Mobile CLC systems offer potential advantages in usability and integration with daily life.

Purpose of the Study:

  • To assess the efficacy of a mobile closed-loop control (CLC) system compared to sensor-augmented pump (SAP) therapy.
  • To evaluate the superiority of mobile CLC in reducing time below 3.9 mmol/L.
  • To determine the noninferiority of mobile CLC in maintaining time above 10 mmol/L.

Main Methods:

  • A 3-month, parallel-group, randomized unblinded trial (NCT02985866) involving 127 participants with type 1 diabetes.
  • Comparison of mobile CLC system against SAP therapy.
  • Coprimary outcomes: CGM-measured time below 3.9 mmol/L and time above 10 mmol/L.

Main Results:

  • Mobile CLC significantly reduced CGM-measured time below 3.9 mmol/L (2.4% vs 4.0% in SAP; P < 0.0001).
  • Mobile CLC was noninferior in CGM-measured time above 10 mmol/L (34% vs 39% in SAP; P < 0.0001).
  • One severe hypoglycemic event occurred in the CLC group, unrelated to the device.

Conclusions:

  • The mobile CLC system met its coprimary endpoints, demonstrating superiority in reducing hypoglycemia and noninferiority in avoiding hyperglycemia.
  • Mobile CLC is feasible and may offer usability advantages over embedded systems.
  • Stable system component connectivity is crucial for optimal performance.