Desang diabetes magazine diabetes news

NEWS

Roche and Johnson & Johnson are joining companies like Apple, Fitbit

and Samsung in a US digital health pilot programme. The FDA wants

to put in place a new, more pragmatic way of evaluating digital health

products that could speed up their approval by scrapping the need

for a pre-market submission and allow lower levels of submission

content. To help it test this the US regulator has picked a range of

pharma and tech giants to participate in the first-of-its-kind pilot,

which it hopes will 'revolutionise' digital health. The scheme would

allow the FDA to 'pre-certify' digital health technology, by focusing

more on the company behind it rather than primarily focusing on

the product itself. Nine firms were picked for the pilot: Apple, Fitbit,

J&J, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool

and Verily. But the FDA said it had received interest from more than

100 companies. The regulator said its selection process looked to

include a range of different perspectives and unique approaches to

digital health technology development.

SciFluor has announced positive top-line data from its

phase 1 study of SF0166, a topical ophthalmic solution

for Diabetic Macular Edema (DME) patients and hopes

to advance the product into a Phase 2 trial. The study

demonstrated good safety with no drug-related serious

adverse events and greater than 50% of treated patients

experienced a decrease in retinal thickness. The company

reports that results from this study are encouraging and

demonstrate a potential breakthrough in the treatment

of retinal disease and for a treatment to be administered

topically as an eye drop.

www.scifluor.com

The US Food and Drug Administration has approved

the FreeStyle Libre Flash Glucose Monitoring System as

a replacement for blood glucose monitoring (BGM) for

adults with diabetes. The glucose sensing technology is

the only personal continuous glucose monitor (CGM) that

does not require finger stick calibration. Designed to be

accessible and affordable for the 30 million people with

diabetes in America, the FreeStyle Libre system is the

longest-lasting personal glucose sensor available in the

United States.

LIBRE FDA APPROVAL

NEWS BITES

The NHS has announced a 250-calorie limit on

confectionary sold in hospital canteens, stores, vending

machines and other outlets. Helen Dickens, Assistant

Director of Campaigns and Mobilisation at Diabetes UK,

comments: "It's great to see the NHS taking steps to

help make it easy as possible for us all to make healthier

choices - particularly for those in hospital - and in doing

so reduce our risk of Type 2 diabetes. We look forward to

seeing more information on how it will work in practice.

However this is just one piece of the puzzle when it

comes to tackling obesity. We need to go much further,

which is why we are also calling for the Government to

toughen restrictions on junk food marketing to children, to

end price promotions on unhealthy foods and introduce

mandatory front-of-pack food labelling."

SNACK ATTACK

EYE ADVANCE

FDA TO PRE-CERTIFY

DRUG DELAY COMMON

Lisa Rapaport, writing for

Reuters Health, reports,

"Three in ten adults with

Type 2 diabetes who need

to start taking insulin to lower

their blood sugar don't begin

treatment when their doctors

tell them to, a recent study

suggests. On average, these

patients delay insulin for

about two years, researchers

report in Diabetic Medicine.

Insulin therapy is typically

offered to patients with high

blood sugar levels. While

some previous research has found diabetics often fail to start insulin

when it's needed, it's been unclear how much of this is due to doctors

failing to prescribe the medication versus patients refusing to take it.

For the current study, researchers examined data from electronic

physician notes at Brigham and Women's Hospital from 2000 to

2014. Of the 3,295 patients with diabetes included in the analysis,

nearly one third declined a physician's advice to begin insulin at the

time the recommendation was made, according to the report. People

who initially declined, but ultimately accepted the recommendation

to start insulin, started the insulin therapy more than two years later,

on average, during which time their blood glucose levels climbed.

Sanofi funded the study.

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  12. Desang diabetes magazine diabetes news, Medical Detection Dogs
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  18. Fitlegs diabetes socks, Diabetes footcare, diabetic footcare
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  32. low carbs, low carbing, low carbohydrate diet, carb counting, Beverley Glock
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  34. Making Carbs Count, carb counting, how to read a nutrition label
  35. Making Carbs Count, carb counting, how to read a nutrition label
  36. Making Carbs Count, carb counting, The Pioppi Diet Dr Malhotra
  37. Accu-Chek Insight insulin pump
  38. Free diabetes magazine, Living with diabetes, the diabetic diet, carb counting

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