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SD Codefree meter- accurate or not

Dexterdobe

Well-Known Member
Messages
305
Location
Norfolk England
Type of diabetes
Type 2
Treatment type
Diet only
Dislikes
Being unwell and seeing BG levels soar
Since I was diagnosed with T2 last November I've tested my BG with the SD Codefree meter. The test strips are £7.25 for 50; far less than any other make I have seen advertised, but a lot of users complain that the SD is inaccurate and reads up to 1 mmol higher than it should.
I have read on this forum that many members who have their T2 under control, regularly see BG readings in the 5's. By contrast, my readings were averaging 6.9 and I only very rarely saw a reading below 6. I was convinced that the 3 month follow up HBa1c test would show that I was still well within the diabetic range, but I was pleasantly surprised when it came in at 42 (Down from 53 in November).
I looked and found a conversion chart. 42 equates to an average mmol of 6.9, so it would seem that my SD meter is spot on or am I missing something?
 
I believe @Rachox uses a Codefree and records her readings on mysugr which gives a predicted HbA1c - and that it has been very close each time to her actual HbA1c results.
 
Smashing reduction, well done. I use the Codefree and, fingers crossed, no complaints yet.

Keep up the good work.
 
I use the codefree meter and am happy with it.
 

The meter complies with the latest standard for accuracy.

https://www.diabetes.co.uk/blood-glucose-meters/sd-codefree-blood-glucose-meter.html
 
I believe @Rachox uses a Codefree and records her readings on mysugr which gives a predicted HbA1c - and that it has been very close each time to her actual HbA1c results.

Indeed I do use the Code Free and as eggs11 says I put my readings into the My Sugr app and have found it to tally quite closely. In Sept I got 34.4 MySugr 36 from lab test, Dec I got 32.9 MySugr and 33 from lab test then Feb 34 MySugr and 35 from lab.
 
Thanks for your replies. Maybe the people who complain the SD reads high really do have high readings
 
I have used the Codefree for 5 months now. My 'average' based on only 3 readings a day was spot on with my December HbA1c. I'm having another HbA1c in 3 weeks time so I'll see how close it is this time.
 
You can get the strips cheaper than that of you buy from Home Health there is a discount code but I can't remember what it is. 're accuracy I spent a week in hospital recently and a couple of times I tested my blood on my meter as well as the hospital one at the same time. Pleasantly surprised to find only a 0.1 difference each time. The hospital one was a computerised super duper system so I reckon the code.free gives really accurate results. I also use the My Sugr app and got a predicted hba1c of 39.9 and an actual.hba1c of 40.0 so very happy with code free!
 
Oh yes here are the discount codes for strips from Homehealth, if you buy 10 packs it works out at £5.98 per pack:
5 packs 264086
10 packs 975833
 
remember to use the box which says Yes, i am a diabetic to get the VAT off.
 
You may all wish to see this interesting study

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5588599/

Conclusion
We conclude that the glucometer (SD Codefree) is as accurate as the auto analyser and therefore can be conveniently used as a rapid easy-to-use alternative. However, it is recommended that further studies be carried out using multiple glucometer brands.
 
Actually this is not quite true. The CCG's all conducted an extensive survey to select meters they would support, based mainly on price of strips. Meters had to meet the ISO standard otherwise they were eliminated and not selectable for NHS use, The SD Codefree did not meet the required standard, and was removed from selection. I have to buy mine privately.

I have found that over the last 3 years the SD consistently reads 1 mmol/l higher than any other meter I have tested it against, mainly Abbott or Caresense meters. In my case I find that my HbA1c comes in close to the average vlue between the SD and whatever meter I am parallel testing with, i.e. about 0,5 mmol/l below the SD average.
 

Attachments

Actually this is not a surprise. SD actually make and sell the blood autoanalyser kit to labs. It is tbeir primary business, and home test meters is a sideline for them.

Edit to add: Note that there is a +/- 3.0 mmol/l variance allowed between the meter and the Analyser. This means that they count a SD Codefree result of 14 MMol/l to be accurate compared to an analyser reading of 7 mmol/l. So I would say barn door politics applies here, This is NOT a good test with that variance allowance,

Edit to add: The ISO standard 2015 for bgl home meters is that at low bgl levels (5.0.mmol/l or less) then the reading must be within +/- 0.8 mmol/l for 95% of all readings, and they do not seem to prove this part of the requirement at all. I find personaly that when I start to feel the onset of a hypo, my Caresense meter read 4.1 0r less, but my SD is telling me it is above 6 mmol/l. So by the SD I would be safe to drive, by the Carsense I need carbs, and my body is starting to show physical signs of stress. I believe my body.

The autoanalysers used in the labs need to be more accurate than the home meters, and are typically better than within 1% of an assayed result.
 
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I know the thread is about SD Codefree meters.

The three meters I own have a fairly accurate readings when compared to each other. The two Performa meters are pretty much spot on with each other. The Freedom Lite is anything between +/- 0.5 mmol/L with the others, which is near enough close enough for me.

 
I’m another using the SD Codefree. Very happy with it. Recently got the Caresens Dual for ketone testing purposes. It came with 10 free BG strips, so I’ve been able to do a few comparisons- no noticeable difference.
 

Coventry and Rugby CCG have excluded the SD Codefree because it does not auto detect a control solution.

Greater Manchester CCG, and West Berkshire CCG have excluded the SD Codefree because the manufacturer failed to submit 'published' independent evidence of attainment of ISO 15197:2013

And the list goes on. The SD Codefree is NOT excluded on the grounds of accuracy.

The meter has been independently tested by a Notified Body - namely TUV SUD and carries the CE Mark which means that it meets all relevant standards for sale within the European Economic Area.
 
The Report I saw from TUV was for tests against the 2003 version of the standard, not the 2015 issue that GMMMB was requiring in their pilot study. Passing the 2003 issue would give them the right to use the CE mark. The CE mark is a one off test assessment of the equipment at the time of certification, and there are no need for production line testing or ongoing upgrading of equipment if standards get changed.

I worked in Aerospace industry so I know what CE mark and Certification means. They are assessments to show that a certain set of standards was used in the design of the equipment, and re-certification is only mandated if there are substantial changes to the design. So CE mark is a snapshot in time, and I do not believe that SD have demonstrated any compliance to the latest standards, which is why they were rejected. In my job I used TUV and similar asseyor labs to demonstrate that my equipment was flight qualified, and we had to meet MIL STD specs that are far more severe that any that a commercial outfit like SD would be expected to meet.
 

Your experience of CE marking is different to mine then!

I am currently working in the medical device industry (radiotherapy) and have spent the last 8 months writing reports for a notified body (not TUV) to get our equipment approved to a revised and updated standard before the cut off date - or we stop shipping.

Medical devices can no longer carry the CE mark after the enforcement date of the latest standard (in the case of glucose test meters - 2016.) unless they fully meet the requirements of that standard.

The enforcement date may differ from country to country (China are typically a few years behind) but across the EEA it is standardised.
 
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