US drug regulator approves ‘artificial pancreas’ pump for diabetics
The US Food and Drug Administration (FDA) has approved the first ‘artificial pancreas’ insulin pump for type 1 diabetics, which constantly monitors blood sugar to provide the correct dose.
Medtronic’s MiniMed 670G measures glucose levels every five minutes through a sensor that attaches to the skin and automatically alters the dose of insulin given through an infusion patch connected to the insulin pump, which is attached to the body with a strap. The hormone is then delivered to the patient through a catheter.
Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, says: “This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin.”
It is the first FDA-approved device that is intended to automatically monitor glucose and provide basal insulin doses for patients with type 1 diabetes over the age of 14 years.
While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter the effects of eating a meal.
The FDA had considered results from a clinical trial of 123 patients with type 1 diabetes which tested the device over a three-month period, with the regulator saying it had worked with the company from the earliest stages to get the technology to patients as quickly as possible.
Although it has been shown to be safe with no severe adverse effects reported, the FDA says a post-market study will be set up to monitor how MiniMed performs in real-world settings.
Medtronic is currently evaluating the device in children aged 7–13 years. It is not recommended for patients under the age of six years or patients who require less then eight units of insulin a day.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20201775
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