PracticeUpdate Diabetes June 2019

CONFERENCE COVERAGE 16

28 th Annual Scientific & Clinical Congress of the American Association of Clinical

Endocrinologists 24–28 APRIL 2019 • LOS ANGELES, CALIFORNIA, USA By The PracticeUpdate Editorial Team

A “Hypo-Triad” and Comprehensive Glucose Paragon Demonstrate Superior Improvement in Glycemic Control Standard metrics may underestimate the effectiveness of the MiniMed™ 670G system. A hypo-triad composed of areas under the curve, frequency, and duration of hypoglycemia and comprehensive understanding, beyond that of A1c alone, of howmultiple metrics change in response to an intervention.

pediatric MiniMed™ 670G pivotal trials. Areas under the curve, frequency, and duration of hypoglycemia <70 mg/dL (hypo- triad) were used to derive the “intensity” and “volume” of hypoglycemia. The comprehensive glucose pentagon area was calculated using mean glucose, intensity of hypoglycemia and hyperglyce- mia, time out of range (reciprocal of time in range) and coefficient of variation. Analysis by hypo-triad showed a reduc- tion in intensity (–43%) and volume (–71%) of hypoglycemia between the run-in and study phases in adults/adolescents. In pediatric subjects, a 37% reduction in intensity and 61% reduction in volume of hypoglycemia <70 mg/dL were observed. The comprehensive glucose pentagon area was reduced by 8% from the run-in vs study phase in adults and adolescents. The comprehensive glucose pentagon area was reduced by 12% in the pediatric trial. Dr. Vigersky explained that the Medtronic MiniMed™ 670G system was approved for use in type 1 diabetes in 2016 for adults and adolescents age ≥14 years and in 2018 for children aged 7 to 13 years. Approvals were based on safety and effi- cacy in reducing glycated hemoglobin (A1c) in pivotal trials.

glucose paragon have demonstrated more robust and clinically relevant improvement in overall glycemic control than standard metrics, such as A1c. The measurements were used to estimate the effectiveness of the MiniMed™ 670G hybrid closed-loop system, which may be underestimated by standard metrics. This outcome of an analysis of pivotal trial data of the MiniMed™ 670G in adults, adolescents, and children with type 1 dia- betes using novel composite metrics was reported at the AACE 2019. Hypothesizing that standard metrics may underestimate the effectiveness of the MiniMed™ 670G system, Robert Vigersky, MD, of Medtronic Diabetes, Northridge, California, and colleagues set out to use novel composite metrics derived from continuous glucose monitoring to better understand how the 670G may improve glycemic control beyond A1c. Dr. Vigersky told Elsevier’s PracticeUpdate , “Evaluating the results of studies in diabetes requires a comprehensive

“By developing composite metrics such the hypo-triad and comprehensive glucose pentagon,” he noted, “and applying them to adult and pediatric subjects enrolled in pivotal studies of the 670G system, we hoped to demonstrate that improvement in outcomes entailed more than just an improvement in A1c.” He continued, “Continuous glucose mon- itoring is increasingly used to manage diabetes, either standalone continuous glucose monitoring or in combination with pumps. “Using the robust data that continuous glucose monitoring provides (that is, 288 measurements of glucose daily),” Dr. Viger- sky said, “We are afforded an opportunity to better understand the impact of a variety of interventions, be they new technology, pharmaceutical, or educational in nature, on glycemic control.” Dr. Vigersky and coinvestigators analyzed data derived from continuous glucose mon- itoring from the 2-week run-in and 3-month study phases of the adult/adolescent and

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