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New Flash Glucose Monitoring from Abbott - Bloodless Testing

SpikeThacker said:
has this been authirised by DVLA does anyone know?
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Maybe a dumb question, but where is it written that the DVLA has to authorise a specific device. It's a blood glucose testing system. I would be unsurprised to discover that DVLA would still accept a urine dipstick test. Is there any legislation or regulation anywhere that says "only test with permitted devices or you can't drive"?

And are we talking about normal driving, or PSV / PCV driving?
 
Spiker said:
Maybe a dumb question, but where is it written that the DVLA has to authorise a specific device. It's a blood glucose testing system. I would be unsurprised to discover that DVLA would still accept a urine dipstick test. Is there any legislation or regulation anywhere that says "only test with permitted devices or you can't drive"?

And are we talking about normal driving, or PSV / PCV driving?
Click to expand...

It tests interstitial fluid as opposed to blood. Much like a CGM, it is not approved for ore driving readings. You still have to finger prick
 
hale710 said:
It tests interstitial fluid as opposed to blood. Much like a CGM, it is not approved for ore driving readings. You still have to finger prick
Click to expand...
Sure I get that. But what is the DVLA regulation that says "must be a fingerstick blood test", rather than say a urine test or a CGM blood value, or whatever?
 
Spiker said:
Sure I get that. But what is the DVLA regulation that says "must be a fingerstick blood test", rather than say a urine test or a CGM blood value, or whatever?
Click to expand...

I don't have the paperwork to hand, but in fairly certain it says blood glucose making urine or interstitial fluid invalid as pre driving tests
 
From:

DRAFT MINUTES OF THE SECRETARY OF STATE’S HONORARY
MEDICAL ADVISORY PANEL ON DRIVING AND DIABETES MELLITUS
HELD ON TUESDAY, 1ST OCTOBER 2013


6. Blood Glucose Meters
6.1. Dr Gary Thorpe, Honorary Senior Lecturer at The University of Birmingham gave a
presentation on “Blood Glucose Meter Accuracy, What is it, Measurement and
Interpretation”.
6.2. The Panel also discussed the following paper: System Accuracy Evaluation of 43 Blood
Glucose Monitoring Systems for Self-Monitoring of Blood Glucose according to DIN En
ISO 15197 – Journal of Diabetes Science and Technology 2012: 6: 1060-1075.
6.3. All meters on the market in the European Union need to meet minimum accuracy
standards. These are CE marked and meters which are not CE marked cannot be
marketed in the European Union. These meters measure plasma glucose levels.
Concerns were raised about the accuracy of some meters particularly at lower blood
glucose levels and the Panel will consider this and whether a stricter accuracy standard
needs to be set for lower glucose readings on the meters used by Group 2 drivers on
insulin. It was also noted that the memory must be sufficient to store at least 3 months
worth of blood glucose readings. In addition there are many operator dependent factors
which do influence meter accuracy and it is important that this information is clearly
available for users.
 
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