Hiten Chawla, MBA: Expanded Indications, Real-World Results for Closed Hybrid Loop System
JUNE 24, 2018
As Hiten Chawla, MBA noted, this is a very exciting medical meeting for Medtronic.
Near the start of the 2018 American Diabetes Association (ADA) 78th Scientific Sessions in Orlando, FL, the prominent medical device company announced a new indication from the US Food and Drug Administration (FDA).
The FDA had expanded Medtronic’s MiniMed 670G hybrid closed loop system for use in patients with type 1 diabetes (T1D) aged 7 years and older.
The indication came 9 months after the device was originally approved by the FDA for use in patients 14 aged years or older. It also coincided cleanly with the ADA meeting, at which the company announced real-world data showing the device positively affects patient hypoglycemia and hyperglycemia time and range rates.
Similarly in pediatric patients, the expanded indication was backed by study results involving 105 children aged 7-13 years old with T1D, wherein time and range increased a mean 56.2% and 65%, respectively. Pediatric patients’ mean glycated hemoglobin (A1C) levels also decreased from 7.9% to 7.5% within 3 months of baseline.
In an interview with MD Mag at ADA 2018, Chawla, vice president of Global Marketing, Advanced Insulin Management, also discussed an expanded portfolio that now features a “smart” continued glucose monitoring (CGM) category that will additionally aid patients trying to manage glucose levels better.
It’s a positive future for diabetes devices, but Chawla also reveled in the present news.
"We're very excited about the expanded 670G, and the fantastic real-world outcomes that are there, are phenomenal for us to be excited about," Chawla said.
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