FDA Expands Approval of Closed-Looped Insulin Delivery System

Share this content:
FDA Expands Approval of Closed-Looped Insulin Delivery System
FDA Expands Approval of Closed-Looped Insulin Delivery System

MONDAY, July 2, 2018 (HealthDay News) -- Approval of the MiniMed 670G hybrid closed looped system for diabetes management has been expanded to include individuals aged 7 to 13 years with type 1 diabetes, according to a report published by the U.S. Food and Drug Administration (FDA).

The MiniMed 670G hybrid closed looped system was originally approved in September 2017 for use in patients age 14 years and older with type 1 diabetes. The device works by measuring glucose levels in the body every five minutes and automatically adjusting insulin delivery. The system includes a sensor that measures glucose levels under the skin, an insulin pump, and an infusion patch connected to the pump. Users need to manually request insulin doses to counter carbohydrate consumption.

The FDA evaluated data from a clinical trial of the system in 105 individuals aged 7 to 11 years. Participants wore the device for about 3.5 months, and three phases of the study assessed home and remote use. No serious adverse events were recorded in association with use of the device, which was considered safe for people aged 7 to 13 years with type 1 diabetes.

"Today we're extending these opportunities to younger children who are especially vulnerable to the impact of this disease, such as the disruptions in sleep that can be caused by the need for frequent blood glucose checks," FDA Commissioner Scott Gottlieb, M.D., said in a statement.

More Information

Share this content:

is free, fast, and customized just for you!




Already a member?

Sign In Now »

Drug Lookup

Browse drugs by: BrandGenericDisease

More in Home

FDA Approves First Customizable Insulin Pump

FDA Approves First Customizable Insulin Pump

Product works by delivering insulin under the skin at set or variable rates

Sepsis Common in Terminal Hospitalizations, Discharges

Sepsis Common in Terminal Hospitalizations, Discharges

Most common underlying causes of death in sepsis are solid and hematologic cancers, chronic heart disease

Fewer Older Men Assessed, Treated for Osteoporosis

Fewer Older Men Assessed, Treated for Osteoporosis

Fewer older men than women, even with higher risk, undergo DXA screening, 25(OH)D measurement

is free, fast, and customized just for you!




Already a member?

Sign In Now »