Am I Missing Something Here?

Today, I will ask your forgiveness before I start. Please?

I may be a bit slow, or not the sharpest knife in the block, or even have a 'roo or 2 lose in the top paddock.

Because I don't understand.

I am not a medical professional. This post is about questioning, not offering advice or recommendations!

Also, sorry as this may be long post and it contains big numbers!

What I Hear People Say

But can somebody tell me why I keep hearing people say:

● "Their child hates pricking their fingers several times a day to measure their BG levels (Blood Glucose) because their fingers are so sore",

Or

● "I wish there was a way I don't have to pick their fingers everyday. It doesn't take long before I'm back to the fingers on the other hand."

Or

● "We are not eligible for the subsidy to get the "Continuous Glucose Monitor (CGM) patch".

In Australia such a device is subsidised for those with Type 1 diabetes. For those not covered the cost I believe the cost is around $4,000 - $5,000.

My Neighbour

My neighbour has Type 2 diabetes. She is in the category of what we call "an older Australian". She is a retired nurse (30+ years).

Late last year she said she heard there are smartwatches that could measure blood glucose levels enabling her to monitor her blood glucose levels as frequently as she liked without pricking her fingers!

Would I help her research if there was indeed such a device and how expensive were they?

She was using test strips which are subsidised for her and capped at AU$7 for 50.

The Normal price is around $50 per pack of $50. She bought 4 packs every 2 months.

She didn't want to use the CGM patch as while it is an "Approved" by the FDA and Australia's TGA, there were enough reports that some people found it uncomfortable, or not suitable for them, or could not afford it.

The CGM patch can be linked to apps on iPhones and Android phones for ease of reading.

We did the research and found there are smartwatches that have such a feature. They ranged from AU$50 upwards.

Why Aren't There Subsidies for Wearable Devices (Smartwatches)?

The key here is...NO smartwatches offering non-invasive monitoring of Blood-Glucose (BG) levels have FDA or TGA approval.

In fact, the FDA and many Diabetes organisations and businesses warn against wearing them because they do NOT have FDA approval.

The FDA criteria is:

● At least 95% of all readings must be within 15% of readings from a blood glucose monitor that’s currently FDA cleared and known to be accurate.

● At least 99% of all readings must be within 20% of readings from a blood glucose monitor that’s currently FDA cleared and known to be accurate.

What My Neighbour Found Using a Wearable Device

However, my neighbour purchased her smartwatch, though with some skepticism.

For 3 weeks she continued to prick her finger 4 times a day and matched the result with that shown on her watch.

She then moved to pricking her finger once a day and comparing the result against the smartwatch.

She found:

● Her worst reading at her lowest BG level of 4.6 was 0.2 difference from the "Test Strip" result. This is a 2.17% difference.

● Most of her results at low, mid and high levels was a difference of 0.1. This is 1.3% difference at 7.6.

Both results are well within the FDA guidelines. Note: Obviously this can not be classed as a scientific study.

My neighbour now uses the strip 1 or 2 times a week just to keep a check on the accuracy.

She says it is wonderful not having sore fingers.??

Also the watch "alarms" if she goes below or over a limit. She also likes how it shows her steps each day, her heart rate, temperature, blood pressure.

Remember she was a nurse for 30+ years and knows what the numbers mean and what the danger levels are.

The Big Question

My question is why aren't the FDA and TGA giving a priority to research to help smartwatches and other non-invasive wearable devices reach "Approved" status.

Do they like it that parents have to deal with kids who don't want to do it because they have a sore finger?

Being cynical I must wonder if it is about "big pharma/medicine".

Why?

Some "Big Pharma" or related organisations earn serious money from sales of monitoring and reading devices, patches and test stripes.

So Could It Be Due to Money?

● My neighbour was paying at a subsidised rate around $168 a year for the a packet of 50 Test Strips, and a one-off AU$50 for the device to read the Test Strip.

There are 1,468,142 people as registered in Australia with diabetes.

10% (approx.) of diabetics in Australia have Type 1 diabetes. Let's assumes these don't use the Test Strips as they have access to a subsidised CGM.

Lets assume the remaining 1,321,328 people with Type 2 Diabetes purchase 24 packs of "Test Strips" per year (2 packs per month).

● 10% are pensioners (132,132 people) purchase 24 packs @ AU$7 per pack = AU$22,198,176

● 80% are not eligible for subsidy (1,189,195) 24 packs @AU$50 per pack = AU$1,427,034,000 (AU$1.427B)

That is a whopping AU$1,449,232,176 (AU$1.449B) per year for "Test Strips" alone!

● Smartwatch @ AU$54 for 1,321,328 people is AU$71,351,712 (AU$71.351M).

(95%!!! (AU$1.377B) LESS than the amount for test stripes for 90% of diabetics.

Imagine if they even saved AU$1B per YEAR and allocate AU$50 million from Year 1 savings to "before and after" research on wearable devices.

Can you imagine the impacts on the economy if AU$1B per YEAR being put back into Australia's economy?

Just asking for a friend??

#Diabetes #GovtFunding #MedicalSubsidies #QualityofLife