Recent Posts - DAFNE Online

Sep 23, 2015

Annette Bell 58 posts

Ok, point taken! Wink

Sep 23, 2015

Annette Bell 58 posts

Topic: General Discussion / Dosage auto-calculation in apps

If anyone is interested, I received this e-mail reply to the one I sent re this subject:

Dear Mrs Bell

Thank you for your e-mail. Details of compliance investigations are confidential, however we are able to provide some general information on apps.

Full details of the guidance on â€˜Medical device stand-alone software including appsâ€™ can be found at the following link:

https://www.gov.uk/government/publications/medical-devices-software-applications-apps/medical-device-stand-alone-software-including-apps

This guidance sets out why apps in some instances are considered to be medical devices and in the section entitled â€˜Software appsâ€™ there is a reference to the measurement of blood sugars.

Apps that are considered to be medical devices should have a CE mark as this shows it has met the legal requirements for safety, quality and performance when it is used as the manufacturer instructs.

We trust this information is helpful.

Yours Sincerely

Leo Syron
Compliance Inspector
European Regulatory Affairs
Medicines and Healthcare products Regulatory Agency
4th Floor, 151 Buckingham Palace Road
London
SW1W 9SZ
Tel 020 3080 7207
Fax 0203 118 9809
Mobile: 07770 678 430
To report suspected non-compliant medical device:
E: [email protected]

To report suspected counterfeit products:
E: [email protected]

Sep 23, 2015

alturn 78 posts

Topic: General Discussion / Levemir

You've got a lot going on now but try to be consistent in meals etc will help. And just because you don't feel stressed doesn't mean you aren't (even a little bit).

It's also possible you are still adjusting to Levemir. You need to take what is required to get best control, and this may take some time and continuous monitor and change.

J

Sep 23, 2015

Ellen 10 posts

Topic: General Discussion / Levemir

Thanks for your rely, At least I'm not the only one I thought maybe levemir wasn't working for me and have considered changing back to lantus which I was on when I was first diagnosed about 6 years ago, but it used to sting so they changed me.

Maybe it will keep changing until I have got it right or thinking about it I start university on Monday and will have to drive from Northampton to Leicester so maybe I am stressed about that even though I don't feel like I am. I also stopped doing my thighs for a while and went to buttock and have gone back to thighs again so it could also be this I suppose. I have also had to change my breakfast ratio for 2;1 to 3:1 which I find strange maybe once the levemir is right this might change again.

Ive rang the DSN as well so hopefully they might be able to help as well.

Thanks
Ellen

Sep 23, 2015

alturn 78 posts

Topic: General Discussion / Levemir

I keep changing mine as well, and until recently was always upwards.

Few months ago I was on 14/11 then DSN suggested balancing a bit more, and ended up at 14/14 and considering 15/15. In the last few weeks reduced to 10/10 and may have to reduce further. About the start of reduction, I stopped using my thighs (use stomach for Novarapid) and use buttocks, using areas not used before and which are softer. I expect to keep changing as might depend on site, activity, stress, temperature, mood etc - or it's just unpredictable. And I also reduced by DINNR ratio from 3:1 to 2:1 - I would like to know why (even 3:1 seemed insufficient at times)

Think you just have to accept that you need to change. Perhaps your insulin sensitivity is changing especially if relatively recently diagnosed.

Hope this helps,
J

Sep 23, 2015

Ellen 10 posts

Topic: General Discussion / Levemir

Hello

Does anyone find that they have to change their Levemir dose about every month? A certain amount in the morning and evening seem to hold me level for so long but after a month or so I'm raising overnight.

Thanks
Ellen

Sep 21, 2015

Simon 574 posts

Topic: General Discussion / Dosage auto-calculation in apps

I've been reliably informed it would be upwards of Â£3000 for certification, potentially nearer Â£10k Shocked

Sep 21, 2015

Bananaman 34 posts

Topic: General Discussion / Dosage auto-calculation in apps

How much would it cost, Im up for it

Sep 21, 2015

Garry 328 posts

Topic: Site Development / Updated Forum Items

Sorry I forgot to get back to you. I logged out that day and logged back in again and it hadn't changed.
But it must be fixed as today we are back to the usual, helpful green indicator showing new forum entries.
Thanks very much.
Regards
Garry

Sep 21, 2015

alturn 78 posts

Topic: Site Development / Add Multiple Diary Entries

I am using a PC, and input date as ddmmyy, never recall using ddmmyyyy format (so last two digits of year only)

Sep 21, 2015

Nat-Sav 14 posts

Topic: Site Development / Add Multiple Diary Entries

I'm having trouble with the "Add Multiple Diary Entries" feature. This feature has saved me a lot of time in the past, but now whatever I try, the error message keeps coming up "Entry time and date are invalid lengths".

E.g. If I am entering a BG reading from 10pm on Saturday, I put "19092015" as the date and "2200" as the time, but the error comes up.

Am I missing something?

Sep 20, 2015

Simon 574 posts

Topic: General Discussion / Dosage auto-calculation in apps

Hi Firstrunner,

I'm not sure if you have read the rest of the thread but the whole reason for removing the calculation was forced by the UK and European governments, and was completely out of our hands.

A lot of people have discussed taking on the MHRA or starting a Kickstarter fund to get the app certified as a medical device. So far nobody has stepped up to help.

Sep 20, 2015

Bananaman 34 posts

Topic: General Discussion / Dosage auto-calculation in apps

Someone needs to fix this app, it is now nothing short of dangerous, I have hypos from making mistakes with dosing.

Sep 19, 2015

Alan 49 280 posts

Topic: General Discussion / Insulin Holdalls

Jack,

Have a look at http://www.desang.net/kitbags/ They have a variety of kitbags.

Sep 18, 2015

Jack Butel 3 posts

Topic: General Discussion / Insulin Holdalls

Thanks for your replies very grateful just seems odd the amount of diabetics there are and all the bags, holdalls and containers Ive viewed on line that nearly fit the bill but not 100% ahh well the quest continues once again thanks for your replies and hope you are well x

Sep 17, 2015

Jude 4 posts

Topic: General Discussion / morning blood sugar rise

Hi all. I am currently having the same issue with morning blood glucose rising without me having eaten. I am going to go carb free for a couple of days to try and sort out my basal, which is a split dose of Levemir. I must say, it will be the first time ever, as I am a notoriously "bad" diabetic! This time I am determined to sort myself out. I will keep you posted! Twisted Evil

Sep 17, 2015

derekh1965 99 posts

Topic: Site Development / Problems with Mozilla Firefox

And just found out it's not just when adding diary entries it's also replies to the forum.

Sep 17, 2015

derekh1965 99 posts

Topic: Site Development / Problems with Mozilla Firefox

Hi Simon,

Thanks for your reply. I had alrerady tried most of what was suggested on the link you gave me, clearing cache, removing cookies etc.
I now have it mostly fixed by using ctrl +F5. It still gives the error connection was reset but after ctrl+F5 the page loads okay.
A bit annoying having to ctrl+F5 all the time but at least it works.

Regards
Derek

Sep 17, 2015

Simon 574 posts

Topic: Site Development / Problems with Mozilla Firefox

Hi Derek,

I've had a look at our log files and it does seem like your connection is being interrupted - it's not storing the fact that you're logged in properly on your browser. Can you try doing the steps in this page to see if that helps? https://support.mozilla.org/en-US/questions/1024256

Sep 16, 2015

Simon 574 posts

Topic: Site Development / Updated Forum Items

Hi Garry,

Have you tried logging in and out again?

Thanks,

Simon

Sep 16, 2015

Garry 328 posts

Topic: Site Development / Updated Forum Items

Thanks for reviewing Simon.
Still does not seem to be working for me I'm afraid. I'll try quitting out and see what happens.
Regards
Garry

Sep 16, 2015

alturn 78 posts

Topic: General Discussion / Insulin Holdalls

I use a rigid food box with snap-on top, it holds enough for a day out. If away, I use another for extra days supplies. It doesn't have compartments or insulation (not a big problem in NE Scotland) but it all fits without too much movement, as pens go diagonal. Whether anything of this exact size is still on sale I don't know - I haven't seen one for some time.

Sep 16, 2015

HelenP 218 posts

Topic: General Discussion / Insulin Holdalls

Just another thought. My grandchildren each have a cold pack lunch box (we all live in Queensland...where it gets fairly hot). I know my D-i-L purchased the ones the boys have online. Some pockets but overall dimensions: 20x15x8 cm. Some have a compartment for a freezer brick. Helen

Try: haggusandstookles.com.au

On this site they are called Fridge to Go Small Lunch Cooler Bags (cost $AUD 30)

Sep 16, 2015

HelenP 218 posts

Topic: General Discussion / Insulin Holdalls

I always found that Camera bags were the best...solid and with pockets but with the demise of "cameras" they are now relatively scarce. Good luck. Helen

Sep 15, 2015

Jack Butel 3 posts

Topic: General Discussion / Insulin Holdalls

Im looking for a holdall that will take two insulin pens,and the usual accessories i.e. lancing device, USB metre, test strips, lancets, diary and a couple of other bits. Ive looked on line and some come close but don't take all items. Id appreciate any pointers, links, brand names to look at. Thanking any replies in advance. Idea

Sep 23, 2015 Annette Bell 58 posts	Topic: General Discussion / Apple watch Ok, point taken!

Sep 23, 2015 Annette Bell 58 posts	Topic: General Discussion / Dosage auto-calculation in apps If anyone is interested, I received this e-mail reply to the one I sent re this subject: Dear Mrs Bell Thank you for your e-mail. Details of compliance investigations are confidential, however we are able to provide some general information on apps. Full details of the guidance on â€˜Medical device stand-alone software including appsâ€™ can be found at the following link: https://www.gov.uk/government/publications/medical-devices-software-applications-apps/medical-device-stand-alone-software-including-apps This guidance sets out why apps in some instances are considered to be medical devices and in the section entitled â€˜Software appsâ€™ there is a reference to the measurement of blood sugars. Apps that are considered to be medical devices should have a CE mark as this shows it has met the legal requirements for safety, quality and performance when it is used as the manufacturer instructs. We trust this information is helpful. Yours Sincerely Leo Syron Compliance Inspector European Regulatory Affairs Medicines and Healthcare products Regulatory Agency 4th Floor, 151 Buckingham Palace Road London SW1W 9SZ Tel 020 3080 7207 Fax 0203 118 9809 Mobile: 07770 678 430 To report suspected non-compliant medical device: E: [email protected] To report suspected counterfeit products: E: [email protected]

Sep 23, 2015 alturn 78 posts	Topic: General Discussion / Levemir You've got a lot going on now but try to be consistent in meals etc will help. And just because you don't feel stressed doesn't mean you aren't (even a little bit). It's also possible you are still adjusting to Levemir. You need to take what is required to get best control, and this may take some time and continuous monitor and change. J

Sep 23, 2015 Ellen 10 posts	Topic: General Discussion / Levemir Thanks for your rely, At least I'm not the only one I thought maybe levemir wasn't working for me and have considered changing back to lantus which I was on when I was first diagnosed about 6 years ago, but it used to sting so they changed me. Maybe it will keep changing until I have got it right or thinking about it I start university on Monday and will have to drive from Northampton to Leicester so maybe I am stressed about that even though I don't feel like I am. I also stopped doing my thighs for a while and went to buttock and have gone back to thighs again so it could also be this I suppose. I have also had to change my breakfast ratio for 2;1 to 3:1 which I find strange maybe once the levemir is right this might change again. Ive rang the DSN as well so hopefully they might be able to help as well. Thanks Ellen

Sep 23, 2015 alturn 78 posts	Topic: General Discussion / Levemir I keep changing mine as well, and until recently was always upwards. Few months ago I was on 14/11 then DSN suggested balancing a bit more, and ended up at 14/14 and considering 15/15. In the last few weeks reduced to 10/10 and may have to reduce further. About the start of reduction, I stopped using my thighs (use stomach for Novarapid) and use buttocks, using areas not used before and which are softer. I expect to keep changing as might depend on site, activity, stress, temperature, mood etc - or it's just unpredictable. And I also reduced by DINNR ratio from 3:1 to 2:1 - I would like to know why (even 3:1 seemed insufficient at times) Think you just have to accept that you need to change. Perhaps your insulin sensitivity is changing especially if relatively recently diagnosed. Hope this helps, J

Sep 23, 2015 Ellen 10 posts	Topic: General Discussion / Levemir Hello Does anyone find that they have to change their Levemir dose about every month? A certain amount in the morning and evening seem to hold me level for so long but after a month or so I'm raising overnight. Thanks Ellen

Sep 21, 2015 Simon 574 posts	Topic: General Discussion / Dosage auto-calculation in apps I've been reliably informed it would be upwards of Â£3000 for certification, potentially nearer Â£10k

Sep 21, 2015 Bananaman 34 posts	Topic: General Discussion / Dosage auto-calculation in apps How much would it cost, Im up for it

Sep 21, 2015 Garry 328 posts	Topic: Site Development / Updated Forum Items Sorry I forgot to get back to you. I logged out that day and logged back in again and it hadn't changed. But it must be fixed as today we are back to the usual, helpful green indicator showing new forum entries. Thanks very much. Regards Garry

Sep 21, 2015 alturn 78 posts	Topic: Site Development / Add Multiple Diary Entries I am using a PC, and input date as ddmmyy, never recall using ddmmyyyy format (so last two digits of year only)

Sep 21, 2015 Nat-Sav 14 posts	Topic: Site Development / Add Multiple Diary Entries I'm having trouble with the "Add Multiple Diary Entries" feature. This feature has saved me a lot of time in the past, but now whatever I try, the error message keeps coming up "Entry time and date are invalid lengths". E.g. If I am entering a BG reading from 10pm on Saturday, I put "19092015" as the date and "2200" as the time, but the error comes up. Am I missing something?

Sep 20, 2015 Simon 574 posts	Topic: General Discussion / Dosage auto-calculation in apps Hi Firstrunner, I'm not sure if you have read the rest of the thread but the whole reason for removing the calculation was forced by the UK and European governments, and was completely out of our hands. A lot of people have discussed taking on the MHRA or starting a Kickstarter fund to get the app certified as a medical device. So far nobody has stepped up to help.

Sep 20, 2015 Bananaman 34 posts	Topic: General Discussion / Dosage auto-calculation in apps Someone needs to fix this app, it is now nothing short of dangerous, I have hypos from making mistakes with dosing.

Sep 19, 2015 Alan 49 280 posts	Topic: General Discussion / Insulin Holdalls Jack, Have a look at http://www.desang.net/kitbags/ They have a variety of kitbags.

Sep 18, 2015 Jack Butel 3 posts	Topic: General Discussion / Insulin Holdalls Thanks for your replies very grateful just seems odd the amount of diabetics there are and all the bags, holdalls and containers Ive viewed on line that nearly fit the bill but not 100% ahh well the quest continues once again thanks for your replies and hope you are well x

Sep 17, 2015 Jude 4 posts	Topic: General Discussion / morning blood sugar rise Hi all. I am currently having the same issue with morning blood glucose rising without me having eaten. I am going to go carb free for a couple of days to try and sort out my basal, which is a split dose of Levemir. I must say, it will be the first time ever, as I am a notoriously "bad" diabetic! This time I am determined to sort myself out. I will keep you posted!

Sep 17, 2015 derekh1965 99 posts	Topic: Site Development / Problems with Mozilla Firefox And just found out it's not just when adding diary entries it's also replies to the forum.

Sep 17, 2015 derekh1965 99 posts	Topic: Site Development / Problems with Mozilla Firefox Hi Simon, Thanks for your reply. I had alrerady tried most of what was suggested on the link you gave me, clearing cache, removing cookies etc. I now have it mostly fixed by using ctrl +F5. It still gives the error connection was reset but after ctrl+F5 the page loads okay. A bit annoying having to ctrl+F5 all the time but at least it works. Regards Derek

Sep 17, 2015 Simon 574 posts	Topic: Site Development / Problems with Mozilla Firefox Hi Derek, I've had a look at our log files and it does seem like your connection is being interrupted - it's not storing the fact that you're logged in properly on your browser. Can you try doing the steps in this page to see if that helps? https://support.mozilla.org/en-US/questions/1024256

Sep 16, 2015 Simon 574 posts	Topic: Site Development / Updated Forum Items Hi Garry, Have you tried logging in and out again? Thanks, Simon

Sep 16, 2015 Garry 328 posts	Topic: Site Development / Updated Forum Items Thanks for reviewing Simon. Still does not seem to be working for me I'm afraid. I'll try quitting out and see what happens. Regards Garry

Sep 16, 2015 alturn 78 posts	Topic: General Discussion / Insulin Holdalls I use a rigid food box with snap-on top, it holds enough for a day out. If away, I use another for extra days supplies. It doesn't have compartments or insulation (not a big problem in NE Scotland) but it all fits without too much movement, as pens go diagonal. Whether anything of this exact size is still on sale I don't know - I haven't seen one for some time.

Sep 16, 2015 HelenP 218 posts	Topic: General Discussion / Insulin Holdalls Just another thought. My grandchildren each have a cold pack lunch box (we all live in Queensland...where it gets fairly hot). I know my D-i-L purchased the ones the boys have online. Some pockets but overall dimensions: 20x15x8 cm. Some have a compartment for a freezer brick. Helen Try: haggusandstookles.com.au On this site they are called Fridge to Go Small Lunch Cooler Bags (cost $AUD 30)

Sep 16, 2015 HelenP 218 posts	Topic: General Discussion / Insulin Holdalls I always found that Camera bags were the best...solid and with pockets but with the demise of "cameras" they are now relatively scarce. Good luck. Helen

Sep 15, 2015 Jack Butel 3 posts	Topic: General Discussion / Insulin Holdalls Im looking for a holdall that will take two insulin pens,and the usual accessories i.e. lancing device, USB metre, test strips, lancets, diary and a couple of other bits. Ive looked on line and some come close but don't take all items. Id appreciate any pointers, links, brand names to look at. Thanking any replies in advance.