Innovative 'Synthetic Pancreas' Granted Approval for Use Worldwide

Innovative 'Synthetic Pancreas' Granted Approval for Use Worldwide

In a significant breakthrough for diabetes management, the US Food and Drug Administration (FDA) has approved the Medtronic MiniMed 670G, a groundbreaking device designed for type 1 diabetics [1][2][3]. This innovative device combines an insulin pump and a continuous glucose monitor (CGM) into a single system with closed-loop capabilities [4][5].

Key features of the MiniMed 670G include a closed-loop automated insulin delivery system, hybrid closed-loop "Auto Mode", sensor and pump integration, customizable insulin dosing, exercise mode, safety features, and a compact, discreet design. The system uses data from the Medtronic Guardian sensor (CGM) to automatically adjust basal insulin delivery every 5 minutes, maintaining a target blood glucose level around 110 mg/dL and correcting high glucose levels above 180 mg/dL with auto-bolus dosing once per hour [1][5].

During Auto Mode, the system continuously adjusts insulin doses based on sensor glucose values, significantly improving glucose control and reducing HbA1c levels in users [5]. The pump has a touchscreen and rechargeable battery, and the sensor is factory-calibrated (fingersticks needed only as backup), sending real-time glucose data directly to the pump without requiring scanning [1].

Insulin basal rates can be adjusted in very small increments (0.001 units), and bolus dosing in 0.01-unit increments, allowing more precise and tailored therapy than pens or syringes [1]. Users can manually raise the target glucose range during exercise activity, and the system has hypoglycemia safety alarms alerting users when glucose drops below 55 mg/dL [1].

The FDA approval of the Medtronic MiniMed 670G is based upon the successful outcome of a clinical trial of 123 type 1 diabetics [6]. The device promises to make the management of type 1 diabetes easier for sufferers, reducing HbA1c and improving the percentage of time blood glucose is in the desired range, helping to prevent dangerous highs and lows [5].

Medtronic is continuing testing of the device to broaden its scope, including trials to test the applicability of the technology for children aged 7-14 [7]. Francine Kaufman, M.D., the chief medical officer of the Medtronic Diabetes Group, stated that the company is committed to preparing for commercial launch as quickly as possible [7].

Innovations in the field of diabetes management continue to emerge, with researchers developing devices that measure blood sugar every five minutes and autonomously deliver the precise amount of insulin required to balance glucose levels [8]. As these advancements continue, the future of diabetes management looks promising for those affected by this chronic condition.

References: [1] https://www.diabetes.co.uk/news/2017/mar/medtronic-minimed-670g-hybrid-closed-loop-system-approved-by-fda-52399401.html [2] https://www.diabetes.org/resources/technology/medtronic-minimed-670g-system [3] https://www.fda.gov/news-events/press-announcements/fda-approves-first-hybrid-closed-loop-artificial-pancreas-system-treatment-type-1-diabetes [4] https://www.medtronicdiabetes.com/us-en/products/insulin-pumps/minimed-670g-system [5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6074664/ [6] https://www.fda.gov/medical-devices/products-and-medical-procedures/in-vitro-diagnostics/fda-approves-first-hybrid-closed-loop-artificial-pancreas-system-treatment-type-1-diabetes [7] https://www.medtronic.com/us-en/about-us/news/press-releases/2018/09/medtronic-announces-fda-approval-of-the-minimed-670g-hybrid-closed-loop-system.html [8] https://www.diabetes.co.uk/news/2018/sep/fda-approves-worlds-first-smart-insulin-pen-53239940.html

1. The Medtronic MiniMed 670G, an innovative device for type 1 diabetics, combines technology such as robotics and science to offer a closed-loop automated insulin delivery system.
2. This device, approved by the US Food and Drug Administration (FDA), also integrates innovation like a continuous glucose monitor (CGM) to help manage chronic diseases like diabetes and prevent dangerous medical-conditions such as high or low blood glucose levels.
3. As research continues in health-and-wellness and medical-conditions like diabetes, we may see advancements like real-time blood-sugar measured every five minutes and autonomously delivered insulin, improving overall glucose control for sufferers.
4. With these technological breakthroughs, the future holds promising solutions for managing chronic diseases like diabetes, making healthcare more accessible and efficient.

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