NICE Guidelines prevent a non medication solution to Diabetes Type 2

[Mountain Path]

Hi all,

Just finished a phone call with my doctors (who are generally excellent by the way) and the upshot is they can not support my non/low medication way of controlling diabetes due to NICE guidelines.

I was amazed and was wondering if anyone else had hit this barrier.

My non/low medication way is to:-

1. Use a continuous glucose monitor started with Libra freestyle now using a Dexom1
2. Do not eat anything with free sugar in it at all.
3. Generally do not eat anything with/significantly reduce Carbohydrates (virtually none at all)
4. In the event of high sugar then exercise vigorously till it comes down. (generally 20 -30 minutes on a exercise bike works)
5. Only use the prescribed medicine Metformin and Glucizide in emergencies when I am unable to exercise or accidently eat something I cant exercise off (takeaways and restaurants are a killer).

This means I don't take the pills regularly and if I don't 'fall off the wagon' don't take them at all.

This came about when it appeared my medication stopped working and I was unable to access medical advice fast enough (during the worst of the post pandemic doctor availability issues). I had previously (5 years ago) using a VLCD significantly reduced my diabetic markers to the point that I moved to pre-diabetic levels so I knew it would probably work. But it was very hard to maintain this diet at the time (VLCD = 800 calories per day) and slipped back to normal food and medication to negate it.

When I had my delayed annual review it showed a pretty good Hb1a that indicated that I could probably stop medication or just go down to a minimum metformin dose. I discussed my new methodology which was applauded and then unknown to me they stopped my repeat prescription of all medication.

On the call they have said that my method of managing diabetes (take pills as needed only) is not covered by NICE guidelines so they can only prescribe if I undertake to take pills regularly. (The pharmacist was sympathetic spent a lot of time discussing the situation but the end conclusion was the same).

So it seems to me I have three options:-
1. Abandon the new method go back to eating donuts (I miss these the most) and take increasingly powerful medicine to mitigate it.
2. Make sure I never fall off the wagon and thus never need emergency sugar mitigation (really hard especially with the dawn effect, natural surge in blood sugar first thing in the morning regardless of what you eat).
3. Lie to my doctors get the pills on the basis that I am following standard treatment and carry on regardless.

Note that it may be that taking 1 metformin a day or some other low dose will reduce/prevent sudden surges but I suspect it will not.

I understand before drugs were available the only way to treat diabetes was with diet and exercise and cant help thinking that the current approach is to prescribe drugs to facilitate an unhealthy lifestyle.

Although looking at the unnecessary quantities of sugar in nearly all foods and the massive amounts of carbohydrates in our diet, what would be considered a average diet is in effect an unhealthy diet, particularly if you eat ANY takeaways, ready meals or processed foods, most restaurants are also problematic unless you go protein, vegetables and salads only and no sauces (oh an I used to be a gourmet! quietly weeps).

This is a perfect storm and any attempt to escape it seems to be made unnecessarily difficult by the current polices of NICE.

I conclude with an (approximate) quote from my pharmacists 'Maybe your way is the future way we will manage diabetes but it is not supported at present'

I would be interested, obviously with peoples thoughts and own experiences.

Thanks,

Mountain Path.

 

[Deleted member 21371]

Why would you want Metformin?

 

[Sophie DUK]

Hi @Mountain Path, welcome to the forum!

Thank you for sharing. I have to admit, I don't know a lot of the specifics, but have you checked out the NICE guidelines online? https://www.nice.org.uk/guidance/ng28 This section is on the management of Type 2 diabetes.

 

[Mountain Path]

Why would you want Metformin?

The Newcastle diet appears to be a VLCD diet of just 600 Calories per day, so that's pretty much what I did 5 years ago.

Subsequent to that I went back to a 'standard/average diet' some takeaways and 'nice food' a few drinks a few ready meals an occasional treat.

What is a Mediterranean diet? don't they have pastas and pizza? and isn't obesity and type 2 prevalent in Mediterranean countries? ? I suspect it is like the diet that I am in fact following, the low sugar and low carb aspect of what they eat in Italy? Greece? the south of France?

In regard to why do I want Metformin, I don't as a regular medicine, that's the issue, but I do want the ability to take medicine to mitigate an unexpected high. (In the case where I decide to have a couple of beers or go to a restaurant that supplies very tasty but non Mediterranean food).

It seems to me that a healthy biology manages 'bad food' when it is eaten and thus a medicine should manage it in the same way, on an incidence by incidence basis rather the continually keeping the dose up in your bloodstream when its not needed.

 

[Deleted member 21371]

The Newcastle diet appears to be a VLCD diet of just 600 Calories per day, so that's pretty much what I did 5 years ago.

Subsequent to that I went back to a 'standard/average diet' some takeaways and 'nice food' a few drinks a few ready meals an occasional treat.

What is a Mediterranean diet? don't they have pastas and pizza? and isn't obesity and type 2 prevalent in Mediterranean countries? ? I suspect it is like the diet that I am in fact following, the low sugar and low carb aspect of what they eat in Italy? Greece? the south of France?

In regard to why do I want Metformin, I don't as a regular medicine, that's the issue, but I do want the ability to take medicine to mitigate an unexpected high. (In the case where I decide to have a couple of beers or go to a restaurant that supplies very tasty but non Mediterranean food).

It seems to me that a healthy biology manages 'bad food' when it is eaten and thus a medicine should manage it in the same way, on an incidence by incidence basis rather the continually keeping the dose up in your bloodstream when its not needed.

Which is why it's not prescribed as a "get out of jail free" card.
It's not.
It's an accumulative drug that needs to be taken regularly, and only starts to work after about two weeks or regular dosing.
So in this case the Nice guidelines are exactly right.
You either take it as prescribed, or you don't take it.

 

[Mountain Path]

Hi @Mountain Path, welcome to the forum!

Thank you for sharing. I have to admit, I don't know a lot of the specifics, but have you checked out the NICE guidelines online? https://www.nice.org.uk/guidance/ng28 This section is on the management of Type 2 diabetes.

Thanks and interesting.

These guidelines will take a lot of study and decoding, and I will have to consider the implications of challenging the doctors interpretation of the guidelines. but this paragraph seems to have possibilities:-

Adopt an individualised approach to diabetes care that is tailored to the needs and circumstances of adults with type 2 diabetes, taking into account their personal preferences, comorbidities and risks from polypharmacy, and their likelihood of benefiting from long-term interventions.

Which is why it's not prescribed as a "get out of jail free" card.
It's not.
It's an accumulative drug that needs to be taken regularly, and only starts to work after about two weeks or regular dosing.
So in this case the Nice guidelines are exactly right.
You either take it as prescribed, or you don't take it.

I don't think what you are saying "that it cant be used as a 'response to high glucose event drug'" is correct for several reasons':-

1. I have also looked up how it works on numerous sites and they say how it works by:-
Metformin lowers blood glucose levels in 2 ways, by:

• Reducing how much glucose is released from the liver, where it is stored
• helping the cells of your body to absorb more glucose from the bloodstream

None of the sites I have looked at so far indicate it requires a continue dosage to work.

2. In the instructions that come with the drug its states that the doctor will tell you how you should take the medicine and 'If you are taking metformin continuously you should have regular blood tests...' seemingly indicating it can be prescribed as a non regular medicine. There are other aspects in the documentation that imply it is not a 'maintaining continuous levels' medicine.

3. A more technical analysis that can be found here https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5552828/ does not seem to indicate it works to progressively change the biology of the body or need to build up to create an environment where it will work.

4. The instructions for use are 'with or just after food' which clearly indicates it is taken to mitigate the food intake and associated sugar (hence responding to the high glucose event caused by the food) - although this could also be to reduce stomach related side effects admittedly.

5. My own personal experience. I have been logging detailed sugar levels and remedial action for six months. The tech and apps I use allow continuous monitor and rapid feedback on the effect on levels by remedial action (and consuming something you shouldn't) and this data is stored and logged against events such as food eaten, exercise and drugs

I can confirm that while gluicizde seems more effective as a 'response drug' metformin also works quite well. I have experimented in only exercising, only taking one or taking both drugs and have lots of data to back this up.

If you have a website that indicates that the drug works differently by, for example, maintain a continual level in the blood, then that would be of interest.

I suspect that the continual dosage regime is more to manage the patient by ensuring regular usage rather then because it is needed for the dug to work. (oh and to sell more doses, the most profitable drug is one that has to be continually and regularly taken .. for ever)

 

[harbottle]

Metformin only works when it reaches an effective concentration, so you need to keep taking it to maintain that concentration in your body. Just taking it at random times is pointless. After a short period of time it's expelled and the concentration drops (Peak is around 4 hours, I seem to recall.).


Here's a paper talking about it:

Low metformin dose and its therapeutic serum concentration in prediabetes - Scientific Reports

This prospective study aimed to analyze whether the patients with pre-diabetes (pre-DM) reach the TC (therapeutic concentration) of the metformin during repeated, low, constant drug dose. The guidelines do not recommend any metformin dose for this group of patients. Based on the previous study...

www.nature.com

The average elimination half-life in plasma for regular form of the metformin is approximately 5 h. According to this information, to reach steady-state, dosing 2–3 times per day is recommended12.

 

[Leadinglights]

The reason for the advice to take with food is more as that can minimise stomach issues that metformin can cause in some people not that it magically removes the carbohydrates from the food you are eating.

 

[Mountain Path]

Metformin only works when it reaches an effective concentration, so you need to keep taking it to maintain that concentration in your body. Just taking it at random times is pointless. After a short period of time it's expelled and the concentration drops (Peak is around 4 hours, I seem to recall.).

Hi see previous reply to this assertion above. But that said do you have a weblink with technical details about this?

A model of concentrations would be interesting as it would appear by the process you are describing it would not be effective for breakfast as the dose from the night before would have dissipated and taking with or just after food would not have built up enough concentration.

Though relevant questions that could be answered from your data source are:-

1. How long does it take to build up concentration that can be effective as if its a couple of hours it is a responsive drug, although not an ideal one?
2. If it dissipates then it can still be used as an event mitigation drug all you have to do is know you are having a takeaway and take it before you start eating it (however many hours before).
3. What is the minimum rest level of concentration in the blood required to make it effective at all? If as stated it takes two weeks to start working (not my experience) there must be some other mechanism occurring.
4. How long after you stop taking it has its effect (blood or biology change) totally gone.

There must be some studies on these areas somewhere.

In my analysis any meal can cause two sugar peaks:-
1. The free sugar peak that can occur almost immediately (or within 30 minutes) of eating something with sugar.
2. The carbohydrate processing peak that can occur between 1 and 4 hours after the meal.

Peak 1 effective mitigation is in order:-
1. Exercise
2. Glucoside
3. Metformin

Peak 2 effective mitigation is also in order:-
1. Exercise
2. Metformin
3. Glucizide

In both cases exercise is very and the most effective but it is not always possible to enact for various reasons.

In extreme cases, like eating a takeaway, several donuts or a night drinking beers only all three mitigations taken together is effective and sometimes double exercise is required.

I suspect for years without effective monitoring I was exceeding glucose levels even taking the drugs, albeit for an hour or so each time.

It is very possible that regardless of how many drugs are taken to compensate for 'average lifestyle' damage is still being done and probably this is born out by the statistics of even of those who are good and adhere to their regimes.

In my opinion the only effective way to treat this condition (type 2) is not to use drugs to allow a 'bad lifestyle' but to enact a good lifestyle, prompted and encouraged by continual glucose monitoring (when the alarm goes off you know you need to do something about it) and effective point event mitigation using drugs or exercise or other (as people will slip and dealing with each slip is much easier then complete lifestyle changes)

This is also probably a more cost effective solution (Tt=he cost of monitoring and occasional drugs being less then continual dugs and the health effects that will occur when the drugs don't work as effectively as supposed)

It will make people responsible for their condition and create pressure on the food suppliers to produce more healthy food.

 

[Mountain Path]

The reason for the advice to take with food is more as that can minimise stomach issues that metformin can cause in some people not that it magically removes the carbohydrates from the food you are eating.

Yes I have stated that as its mentioned on the NHS website and it says 1 in 10 people will experience digestive issues on the packet.

That said I don't think I have seen any website that claims ' it magically removes carbohydrates' or indeed anyone in this thread suggesting that this is how it works.

See posts above about how it actually works, particularly the link to the abstract on the subject.

If you have received the impression that is my opinion, then I apologise and suggest you re-read my posts in the absolute knowledge that it is not.

 

[Mountain Path]

Metformin only works when it reaches an effective concentration, so you need to keep taking it to maintain that concentration in your body. Just taking it at random times is pointless. After a short period of time it's expelled and the concentration drops (Peak is around 4 hours, I seem to recall.).


Here's a paper talking about it:

Low metformin dose and its therapeutic serum concentration in prediabetes - Scientific Reports

This prospective study aimed to analyze whether the patients with pre-diabetes (pre-DM) reach the TC (therapeutic concentration) of the metformin during repeated, low, constant drug dose. The guidelines do not recommend any metformin dose for this group of patients. Based on the previous study...

www.nature.com

Thanks Harbottle (I think you added the paper as an edit) I will review it now

 

[AndBreathe]

Your surgery need to read the guidelines properly. Section 1.6.7 discussing targets mentions lifestyle and diet. It strikes me that is what you are looking to do, unless you want your GP to fund a Dexcom.

Of course, if your HbA1c is very high, or you have other conditions materially adversely affected by your numbers being raised (and need to get them down asap), there may be other arguments.

 

[Mountain Path]

Thanks Harbottle (I think you added the paper as an edit) I will review it now

Metformin only works when it reaches an effective concentration, so you need to keep taking it to maintain that concentration in your body. Just taking it at random times is pointless. After a short period of time it's expelled and the concentration drops (Peak is around 4 hours, I seem to recall.).


Here's a paper talking about it:

Low metformin dose and its therapeutic serum concentration in prediabetes - Scientific Reports

This prospective study aimed to analyze whether the patients with pre-diabetes (pre-DM) reach the TC (therapeutic concentration) of the metformin during repeated, low, constant drug dose. The guidelines do not recommend any metformin dose for this group of patients. Based on the previous study...

www.nature.com

This document is a great find, thanks.

It talks about a therapeutic concentration of metformin and if the level required can be achieved by very low regular dosage on pre-diabetics. Interestingly it also has this section:-

The DPP (Diabetes Prevention Program)1 study showed that people who are at high risk for T2DM (type 2 diabetes mellitus) can prevent or delay the disease by lifestyle modification (diet and increased physical activity) or taking metformin by 58 and 31 percent, respectively, compared with placebo.

So again you can adopt a good lifestyle or take drugs to allow you to continue with a bad one.

That said there appears to be no consensus (at least in 2016) of what a therapeutic concentration is.. see.
https://pubmed.ncbi.nlm.nih.gov/26330026/ and https://pubmed.ncbi.nlm.nih.gov/29574345/

and I quote :-

Metformin has been available since 1957. Over 50 years later, one can legitimately question whether a clear definition of its "therapeutic concentrations" is available.

But perhaps that is a digression (if an unexpected one) as effectively the concept of building up a therapeutic concentration is the key issue here and how long it takes to build up. I have now found a few 'General information' websites that state varying periods for metformin to become effective from 48 hours upwards.

This would appear to be against my experimental experience, though maybe I have not flushed it all out yet as of late I have been using it more then previously (a twisted knee makes it difficult to exercise)

That said this article is interesting

https://study.com/academy/lesson/metformin-mechanism-of-action-pharmacokinetics.html as as well as stating we don't know how it works it lists several possible mechanisms that work, and reading the pharmokinetics of the drug it could be that some aspects require a continual therapeutic concentration and and some don't. which may explain while i appear to be getting a spot effect (albeit not as effective).

It may be that to support my generally 'Good' lifestyle I need to ask for different drugs that act immediately of which I have found a few contenders.

Thanks for the information and discussion

 

[Deleted member 21371]

Your surgery need to read the guidelines properly. Section 1.6.7 discussing targets mentions lifestyle and diet. It strikes me that is what you are looking to do, unless you want your GP to fund a Dexcom.

Of course, if your HbA1c is very high, or you have other conditions materially adversely affected by your numbers being raised (and need to get them down asap), there may be other arguments.


View attachment 22864

The surgery knows the guidelines it seems.

If, as the op has said, their "annual review it showed a pretty good Hb1a that indicated that I could probably stop medication", how does that indicate the surgery is behaving incorrectly?
And where do the guidelines show it should be prescribed to counteract "a couple of beers or go to a restaurant"

 

[Deleted member 21371]

This document is a great find, thanks.

It talks about a therapeutic concentration of metformin and if the level required can be achieved by very low regular dosage on pre-diabetics. Interestingly it also has this section:-

The DPP (Diabetes Prevention Program)1 study showed that people who are at high risk for T2DM (type 2 diabetes mellitus) can prevent or delay the disease by lifestyle modification (diet and increased physical activity) or taking metformin by 58 and 31 percent, respectively, compared with placebo.

So again you can adopt a good lifestyle or take drugs to allow you to continue with a bad one.

That said there appears to be no consensus (at least in 2016) of what a therapeutic concentration is.. see.
https://pubmed.ncbi.nlm.nih.gov/26330026/ and https://pubmed.ncbi.nlm.nih.gov/29574345/

and I quote :-

Metformin has been available since 1957. Over 50 years later, one can legitimately question whether a clear definition of its "therapeutic concentrations" is available.

But perhaps that is a digression (if an unexpected one) as effectively the concept of building up a therapeutic concentration is the key issue here and how long it takes to build up. I have now found a few 'General information' websites that state varying periods for metformin to become effective from 48 hours upwards.

This would appear to be against my experimental experience, though maybe I have not flushed it all out yet as of late I have been using it more then previously (a twisted knee makes it difficult to exercise)

That said this article is interesting

https://study.com/academy/lesson/metformin-mechanism-of-action-pharmacokinetics.html as as well as stating we don't know how it works it lists several possible mechanisms that work, and reading the pharmokinetics of the drug it could be that some aspects require a continual therapeutic concentration and and some don't. which may explain while i appear to be getting a spot effect (albeit not as effective).

It may be that to support my generally 'Good' lifestyle I need to ask for different drugs that act immediately of which I have found a few contenders.

Thanks for the information and discussion

That's the holy grail for type 2's.
A drug that you can pop with a donut or a family size pizza.

Then again, I'd put 5 stone back on in two weeks, so maybe not.

 

[everydayupsanddowns]

There should also be am ’information for the public’ version of the published NICE guidelines for T2 if you’d appreciate something a little more accessible @Mountain Path

I was fortunate enough to be a lay member of a guideline development group for the T1 in adults guideline some years ago, so I know a little about how the guidance is compiled.

The guidance will have been scoped with various questions regarding which treatment options are the most effective. They will have looked for all published research papers which apply to the target group (in your case adults with T2) and taken into account the quality of the papers (eg how large the studies were, what type of study it was, and whether or not they were likely to give reliable results)

This can mean that for some questions there actually isn’t that much research available, or that many of the published papers have to be disregarded as they don’t meet the inclusion criteria (eg it’s a mixed population and the authors didn’t separate out results for T2).

So the chances are, any study you find will have been on their radar, and would have been included if applicable.

What they are trying to discover, is what is most likely to work for the majority of people - what ‘best practice’ might be.

So you may have developed a bespoke strategy, which you can see works well for you, but the guideline doesn’t really aim for individual approaches. It’s looking for what will work for most people.

 

[AndBreathe]

The surgery knows the guidelines it seems.

If, as the op has said, their "annual review it showed a pretty good Hb1a that indicated that I could probably stop medication", how does that indicate the surgery is behaving incorrectly?
And where do the guidelines show it should be prescribed to counteract "a couple of beers or go to a restaurant"

Mea Culpa - looks like I misread the header post.

I won’t take my reply out or the thread won’t make sense.

@Apologies @Mountain Path . I read your post as your surgery not agreeing I you going for D&E.

 

[Mountain Path]

Your surgery need to read the guidelines properly. Section 1.6.7 discussing targets mentions lifestyle and diet. It strikes me that is what you are looking to do, unless you want your GP to fund a Dexcom.

Of course, if your HbA1c is very high, or you have other conditions materially adversely affected by your numbers being raised (and need to get them down asap), there may be other arguments.


View attachment 22864

Thanks that's helpful and no I am funding my own Dexcom, ill leave the GPS budget for those that cant.

Of course there will come a time when all will have continuous glucose monitoring, when life long drug regimes will be a thing of the past, when only sensible amounts of sugar will be added to our foods, and we will use interventions top react to an actual problem, with our awareness of the situation making these problems occur less often... but it is not this day!

I cant help thinking that one part of the system creates the problem by selling basically unhealthy food that induces illness and another part sells drugs that need to be taken continually so we can keep eating them.

Generally the whole problem is blamed on the weakness of the individuals in the middle, weak if you eat the bad food and weak of you don't take your drugs.

Seems like a dystopian science fiction story.

 

[Mountain Path]

There should also be am ’information for the public’ version of the published NICE guidelines for T2 if you’d appreciate something a little more accessible @Mountain Path

I was fortunate enough to be a lay member of a guideline development group for the T1 in adults guideline some years ago, so I know a little about how the guidance is compiled.

The guidance will have been scoped with various questions regarding which treatment options are the most effective. They will have looked for all published research papers which apply to the target group (in your case adults with T2) and taken into account the quality of the papers (eg how large the studies were, what type of study it was, and whether or not they were likely to give reliable results)

This can mean that for some questions there actually isn’t that much research available, or that many of the published papers have to be disregarded as they don’t meet the inclusion criteria (eg it’s a mixed population and the authors didn’t separate out results for T2).

So the chances are, any study you find will have been on their radar, and would have been included if applicable.

What they are trying to discover, is what is most likely to work for the majority of people - what ‘best practice’ might be.

So you may have developed a bespoke strategy, which you can see works well for you, but the guideline doesn’t really aim for individual approaches. It’s looking for what will work for most people.

This kind of make sense (the solution that works for most people approach) , but it rather supresses innovation and change.

I recall finding the studies on VLCD and pre-drug historical treatments and trying them and they worked.
Since then my medical advisors (GPs and diabetic nurses) also seem to have become aware of these solutions.

In reality the guidelines seem to assume most people do not have the ability to exercise and diet, so it assumes the psychology of most people and that that psychology requires continual drug administration. Its kind of the lazy minimum effort solution.

Of course it doesn't work either as the annual reviews where h1a is actually measured are too far apart and that same lack of focus on health often means the drugs are not taken as they should be. In addition the pinprick regime is very hard to maintain (if you want your fingers to work) and I know of no-one that manages to sample at a decent frequency using that method.

It seems to be that NICE guidelines should be revised (and I believe they are doing this now) so that they allow multiple regimes including the 'best' 'diet and exercise' one, and a workable regime for those who cant achieve this which I think would be one that provides continual awareness and involves continuous monitoring devices or at least more frequent status checks.

Most importantly of all they should support a transition from life long drug usage to a healthier lifestyle, with provision for slippage.

Though in fact at no point has this ever been raised by any medical professional or support organisation, its always been drugs for life and prick your fingers to see if they are working, oh and we will check on you once a year.

 

[Mountain Path]

That's the holy grail for type 2's.
A drug that you can pop with a donut or a family size pizza.

Then again, I'd put 5 stone back on in two weeks, so maybe not.

LOL, yup although a side effect of exercising is also getting fit.

That said if the drug does effectively block sugar you would not increase your weight as a result of the sugar and carbs probably, (People taking it as a diet drug risk?)

That said my current diet has no sugar and virtually no carbs, but I compensate with Proteins and fats, a plate of regional cheeses and a pound of raspberries with a pint of double cream will soon negate any weight loss plans but have virtually no effect on glucose levels. My apps tell me that if I want to continue my route to an ideal BMI its more then just cutting out sugars and carbs, not to mention cholesterol levels that since my diet change has been elevated for the first time ever, there is always something.