FDA expands approval of closed-looped insulin delivery system

July 2, 2018

(HealthDay)—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 under the skin, an , 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.

Explore further: Insulin pump known to be effective in adolescents, adults also benefits children

More information: More Information

Related Stories

Insulin pump known to be effective in adolescents, adults also benefits children

March 19, 2018
The MiniMed 670G insulin pump system (Medtronic, Northridge, California) can improve glycemic outcomes in children with type 1 diabetes as young as 7 years of age, according to an industry-funded study. The results will be ...

FDA approves continuous glucose monitoring system

June 29, 2018
(HealthDay)—The Eversense Continuous Glucose Monitoring (CGM) system, which has a fully implantable sensor to detect glucose, has been approved by the U.S. Food and Drug Administration for use in people age 18 years and ...

Home use of hybrid closed-loop insulin delivery system shown safe and effective

February 13, 2017
A pivotal registration trial to evaluate in-home use of the Medtronic MiniMed 670G hybrid closed-loop insulin delivery system over 3 months showed a significant reduction in HbA1c levels for both adolescents and adults with ...

First-generation 'artificial pancreas' brings hope for people with type 1 diabetes

July 14, 2017
A new "artificial pancreas" being studied by the University of Melbourne could dramatically transform the lives of people with type 1 diabetes.

Artificial pancreas helps hospitalized type 2 diabetics

June 26, 2018
(HealthDay)—Using an artificial pancreas can help hospitalized patients with type 2 diabetes maintain good blood sugar control, a new study suggests.

Closed-loop insulin delivery promising in T1DM pregnancy

March 16, 2018
(HealthDay)—For pregnant women with type 1 diabetes, a closed-loop system is associated with comparable glucose control and significantly less hypoglycemia than sensor-augmented pump (SAP) therapy, according to a study ...

Recommended for you

Switching to certain antidiabetic drugs linked to increased risk of major complications

July 18, 2018
For people with type 2 diabetes, switching to sulfonylurea drugs to control blood sugar levels is associated with an increased risk of complications compared with staying on the drug metformin, finds a study in The BMJ today.

Researchers cure type 2 diabetes and obesity in mice using gene therapy

July 10, 2018
A research team from the UAB led by Professor Fatima Bosch has managed to cure obesity and type 2 diabetes in mice using gene therapy.

Human clinical trial reveals verapamil as an effective type 1 diabetes therapy

July 9, 2018
Researchers at the University of Alabama at Birmingham Comprehensive Diabetes Center have discovered a safe and effective novel therapy to reduce insulin requirements and hypoglycemic episodes in adult subjects with recent ...

New targets found to reduce blood vessel damage in diabetes

July 9, 2018
In diabetes, both the tightly woven endothelial cells that line our blood vessels and the powerhouses that drive those cells start to come apart as early steps in the destruction of our vasculature.

Insurance gaps linked to five-fold rise in hospital stays for adults with type 1 diabetes

July 9, 2018
For a million American adults, living with type 1 diabetes means a constant need for insulin medication, blood sugar testing supplies and specialized care, to keep them healthy and prevent a crisis that could end up in an ...

Abnormal branched-chain amino acid breakdown may raise diabetes risk

July 5, 2018
In the U.S., about five out of 100 expectant mothers develop gestational diabetes mellitus (GDM), a temporary form of diabetes in which hormonal changes disrupt insulin function. Although GDM is often symptomless and subsides ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.