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Insoles to prevent diabetic foot ulcers now available on NHS prescription

With so many ongoing advances in the management of diabetes, this section keeps you up to date with product-related developments and other relevant news

A liquid gel insole that reduces the risk of diabetic foot ulcers has been made available on prescription. The LiquaCare® insole (Autonomed Ltd, Bramham) works by redistributing the wearer’s weight, reducing peak pressure and improving circulation.

The NHS approved the insole based on a 2-year trial in people with diabetes, half of whom had a history of ulceration in the previous year. Despite being in this high-risk category, none of these people developed an ulcer over the next 2 years, and there was a 21.5% reduction in mean forefoot pressure and a clinically significant increase in transcutaneous oxygen pressure of 5%.

This is the first time that a preventative orthotic product like this has been made available on the NHS. The insoles cost £17 per pair and typically last around 1 year.

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Peak foot pressures with and without the LiquaCare insole

IDegLira approved in Europe
Novo Nordisk’s once-daily combination of insulin degludec and liraglutide (IDegLira; Xultophy®) has been granted marketing authorisation in the EU.

The treatment has been approved for improving glycaemic control in conjunction with oral antidiabetes medications in people with type 2 diabetes and inadequate glycaemic control.

Two phase IIIa trials showed that Xultophy resulted in a 1.9% (21 mmol/mol) reduction in HbA1c, with a low rate of hypoglycaemia comparable to that of insulin degludec alone. It also achieved a reduction in body weight compared with basal insulin treatment.

Abbott’s new CGM device receives European CE mark
The FreeStyle® Libre, a Flash Glucose Monitoring device manufactured by Abbott, has received the Conformité Européenne (CE) mark and is now available in seven European countries, including the UK.

The device eliminates the need for routine finger-prick measurements, reading blood glucose levels through a small sensor that can be worn on the back of the upper arm for up to 14 days at a time. The sensor can be scanned whilst still on the arm, under clothing, by passing a reader over it for around a second. Each scan provides a current blood glucose reading, an 8-hour history and the direction that the glucose level is heading. The reader holds up to 90 days of data and presents the information in a simple visual chart.

Extended-release version of Xigduo approved by FDA
The US Food and Drug Administration (FDA) has approved AstraZeneca’s Xigduo® XR, a combination of their sodium–glucose co-transporter 2 (SGLT2) inhibitor, dapagliflozin, and extended-release metformin in a once-daily oral tablet. The product is approved as an adjunct to diet and exercise for improving glycaemic control in adults with type 2 diabetes.

Xigduo XR is already approved in Australia, and the immediate-release version is approved in the EU. SGLT2 inhibitors are in an increasingly crowded market, and dapagliflozin competes with Johnson & Johnson’s canagliflozin and Lilly/Boehringer Ingelheim’s empagliflozin, both approved by the FDA, and Pfizer/Merck’s ertugliflozin, currently in the late stages of development.

New device to simplify insulin pump therapy
Novo Nordisk have launched the world’s first prefilled insulin pump cartridge. The NovoRapid® PumpCart®, which contains the rapid-acting insulin aspart, was developed in a non-exclusive partnership with Roche Diabetes Care to be compatible with the latter’s Accu-Chek® Insight insulin pump.

The PumpCart is designed to overcome the challenge of manually filling the insulin reservoir of classic pumps, a complex and time-consuming procedure that makes the devices difficult to handle for people during pump initiation and requires support from healthcare providers. The manufacturers hope it will increase pump uptake, which in the UK is only 19% in children and 6% in adults.

Both the pump and accompanying cartridge were released in the UK in November 2014.

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