The pump and CGM system, which automates basal insulin rates and pauses insulin delivery to prevent lows, previously was only available for ages 14 and up.
–-by Craig Idlebrook/GluCraig
Medtronic announced today that the FDA has approved expanded use for the Medtronic 670G so that the system will be available to a greater segment of the pediatric population with type 1 diabetes. Under the expanded approval, the partially automated insulin delivery system will be available for children as young as seven years of age.
The new FDA ruling comes after trial results were presented at The Endocrine Society in March 2018 showing the safety of the 670G system with a pediatric population. According to a Reuters report, 105 children with type 1 diabetes, ages 7 to 13, were enrolled in the trial. After 15,000 patient-days recorded of 670G use, there were no reported cases of severe hypoglycemia or diabetic ketoacidosis among the young trial participants. Researchers also found that time spent in a range of 71 mg/dL to 180 mg/dL went up from 56 percent to 65 percent among the pediatric trial participants.
The Medtronic 670G is the first partially automated insulin delivery pump system on the market which features both an automated basal rate setting and an ability to automatically suspend insulin delivery to stave off predicted hypoglycemia. It first was approved by the FDA in June 2017.
The announcement today may steal some of the thunder of an announcement just hours earlier of FDA approval of the Tandem t:slim x2 for use with children with type 1 diabetes as young as six years of age and up. Like the 670G, the t:slim x2 has a feature to suspend insulin delivery based on glycemic trends, but the t:slim x2 lacks the automated basal rate setting of the Medtronic pump system.
You can read the press release about the expanded FDA approval here: http://inpublic.globenewswire.com/releaseDetails.faces?rId=2200706.
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