Boris Kovatchev, United States of America

University of Virginia Center for Diabetes Technology
o Boris Kovatchev, PhD; o University of Virginia, Charlottesville, Virginia, USA; o Professor, School of Medicine and School of Engineering and Applied Science; Founding Director of the UVA Center for Diabetes Technology; o Principal Investigator of a number of projects dedicated to diabetes data science and the development of artificial pancreas systems, including the large NIH/NIDDK International Diabetes Closed-Loop Trial published in the New England Journal of Medicine, and UVA’s Strategic Investment Project “Precision Individualized Medicine for Diabetes.” Author of over 200 peer-reviewed publications. Holds 91 U.S. and international patents, among which are the algorithms behind the Control-IQ closed-loop system (Tandem Diabetes Care, San Diego, CA), approved by the FDA for clinical use by children and adults. Fellow of the National Academy of Inventors.

Presenter of 2 Presentations

 Conference Calendar
PLENARY SESSION

Decision Support Systems and Closed-Loop

Date
Fri, 04.06.2021
Session Name
0320 - Plenary Session 02: ATTD Yearbook 2020 (ID 35)
Lecture Time
14:37 - 14:43
Presenter
Authors
PLENARY SESSION

Pivotal trial and Real-Life data of a Closed-Loop Control (CLC) system - Control IQ

Date
Fri, 04.06.2021
Session Name
0170 - Live Q&A: Plenary Session 03: Advances In Closed-Loop Systems – Lessons Learnt From Clinical Studies (ID 19)
Lecture Time
18:55 - 19:15
Presenter
Authors

Abstract

Abstract Body

In 2018-2020, two randomized controlled pivotal trials tested a new CLC system - Control-IQ® from Tandem Diabetes Care - based on an algorithm developed at the University of Virginia. Both studies were part of the International Diabetes Closed-Loop (iDCL) Trial sponsored by NIH/NIDDK.

NCT03563313 randomized 168 participants ages 14 years or older to Control-IQ vs. sensor-augmented pump (SAP) and met all primary and secondary outcomes. The time in range (TIR, 70-180mg/dL) increased in the Control-IQ group by 11%, compared to SAP, and the time below range (TBR) was reduced by 0.9%, without severe hypoglycemia.

NCT03844789 randomized 101 participants ages 6-13 and achieved similar outcomes: Control-IQ compared to SAP resulted in 11% increase in TIR, 0.4% reduction in TBR without severe hypoglycemia, and reduction of HbA1c by 0.4%.

Two papers in the New England Journal of Medicine presented the complete results, leading to FDA clearance of this system for use by children and adults ages 6 and up.

In February 2021, one-year real-life data became available for 9,451 users of Control-IQ with type 1 and type 2 diabetes. The median percent time in automated control was 94.2%; TIR increased from 63.6% at baseline 73.6% during Control-IQ use; TBR remained consistent at approximately 1%, and the Glucose Management Indicator (GMI) was reduced from 7.2 at baseline to 6.9.

We can therefore conclude that the outcomes of the two pivotal trials of this system were replicated during 1-year real-life use by thousands of children and adults with type 1 or type 2 diabetes.

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