Real Time CGM should be routinely available for all those with Type 1. The latest NICE guidelines…

Real Time CGM should be routinely available for all those with Type 1. The latest NICE guidelines…
professor freeman diabetes research

In England and Wales, access to real time CGM has been a challenge for quite a long time. The consultation documents drag NICE guidance, kicking and screaming, into the present.

The latest drafts are:

Type 1: https://www.nice.org.uk/guidance/gid-ng10265/documents/draft-guideline

Type 2: https://www.nice.org.uk/guidance/gid-ng10264/documents/draft-guideline.

Previous guidance

Back in 2015, when NICE last updated NG17, the guidance for Type 1 diabetes in adults: diagnosis and management, it didn’t have a large amount to say about CGM. Indeed, it said that it was due to be updated, and access has always been limited by requiring specific funding requests to the CCG in relation to the NICE guideline below.

Continuous glucose monitoring

Recommendations on continuous glucose monitoring are due to be updated. NICE diagnostics guidance on integrated sensor-augmented pump therapy systems for managing blood glucose levels in type 1 diabetes is being updated. The update will assess hybrid closed loop technologies, which will be replacing integrated sensor-augmented pump therapy systems.

1.6.21 Do not routinely offer real‑time continuous glucose monitoring to adults with type 1 diabetes. [2015]

1.6.22 Consider real‑time continuous glucose monitoring for adults with type 1 diabetes who are willing to commit to using it at least 70% of the time and to calibrate it as needed, and who have any of the following despite optimised insulin therapy and conventional blood glucose monitoring:

  • More than 1 episode a year of severe hypoglycaemia with no obvious preventable cause.
  • Complete loss of hypoglycaemia awareness.
  • Frequent (more than 2 episodes a week) asymptomatic hypoglycaemia that is causing problems with daily activities.
  • Extreme fear of hypoglycaemia.
  • Hyperglycaemia (HbA1c level of 75 mmol/mol [9%] or higher) that persists despite testing at least 10 times a day (see recommendations 1.6.11 and 1.6.12). Continue real‑time continuous glucose monitoring only if HbA1c can be sustained at or below 53 mmol/mol (7%) and/or there has been a fall in HbA1c of 27 mmol/mol (2.5%) or more. [2015]

The first recommendation from this was that CGM is not routinely recommended, unless there were very specific circumstances. Even then, these were not all that easy to get, without losing your driving license (points 1, 2 and 3) or being able to manage a number of other factors. Fundamentally, it made obtaining real-time CGM (rtCGM) quite a challenge.

2021 NICE Guideline update

Stepping forward six years, and Diabetes Awareness Month and we now have an update to the guidelines. As you can see below, it’s quite a big one.

Yes, you have read that correctly. NICE is now recommending that rtCGM is routinely offered to those with Type 1 diabetes. Not just flash CGM (intermittent scanning CGM as it’s now known, or isCGM), but real-time, of the ilk of Dexcom, Glucomen, Medtronic and Medtrum. While it doesn’t state what the brand is, that’s a big step forward in what we should now expect as the standard of care for those with Type 1.

I’m sure there will be some funding challenges, not least of which is that, if rtCGM is now supposed to be routinely offered to those with Type 1, which budget pot does it come out of? And as a result, we’ll face some challenges in getting our hands on to to rtCGM in the immediate future. However, as NICE guidance now states that rt-CGM should be routinely offered, it gives us a lever to start to undertake patient-activism.

Additionally, the Type 2 guidelines are updated to include finger prock testing for all with type 2 and Libre for those with type 2 on insulin that have experienced severe hypos, are hypo unaware, have disabilities impairing use of blood testing or who are testing more than eight times per day. These are similar criteria required for CGM in the old type 1 guidelines and those originally put in place for flash, and it’s good to see that this recommendation is in place.

What’s it likely to mean in reality?

A comment that a friend of mine often likes to make relates to the question asked by a commissioner in a meeting related to something similar. How do you answer this?”Which cancer patient should I remove treatment from to fund tthis?”
This is incredibly crass, but highlights the point. The NHS has a finite amount of money. But the suggestion that those with diabetes should somehow be put at a detriment to those with cancer should no longer be aided and stigmatised by guidance from NICE. And should never have been the point made by the commissioner in the first place.

And what of those who state:

“It’s from NICE. It’s only a guideline. We don’t have to follow it…”

Let’s just say that that’s a can of worms that commissioners may not want to open…

Is there any precendent?

Back in 2014, a court ruled against a CCG that refused to follow NICE guidelines because they didn’t agree with them. Unlike a Technology Appraisal where there is a 3-month follow up period where funding has to be available, NICE guidelines do not guarantee funding. However, commissioners and trusts that do not follow guidelines are open to challenges by patients, and could, in that process be taken to court.

By having NICE guidelines in place that state that all patients with Type 1 should be routinely offered CGM, there is now an opportunity to challenge CCGs who refuse to offer rtCGM to those who request it. With this in mind, I will be putting together a form to allow everyone who has requested CGM via their clinic, or had clinic appointments where it has not been offered, to report back the response they have received and to allow “patient pressure” to be used to broaden access. Together, we can apply pressure.

At the same time, there are challenges here.

What are the challenges?

Historically, the costs of rtCGM to the NHS have been considerably higher than those of flash-CGM. If they are to be routinely offered to those with Type 1, then they need to be comparable. It’s not clear how that is addressed by this announcement, however, Partha Kar has intimated that there are four aces…

If two of those are Libre, then NICE recommendations for rtCGM, what could the other two be?

Could one be an agreement to reduce the price of rtCGM so that it is aligned with Flash? Only he can answer that. And the other. That’s perhaps not related to a challenge…

Another challenge has been changing the minds of commissioners who have tended to take an uneducated view of diabetes, other than appearing to view it as a drain on their resources. Does NICE guidance help to drive this? In some ways yes. By gathering data on which areas refuse to offer or make it difficult to receive rtCGM, we can start the name and shame process. We will need to publicly name and shame trusts and commissioning groups who routinely do the opposite of, or are subversive with, NICE guidelines, and we will need to encourage Diabetes UK and JDRF UK to join us in that process.

And what of those who use insulin? As I mentioned earlier, there are now recommendations for flash CGM with type 2 and insulin, plus better recommendations for blood testing. Those with other forms of diabetes are not included in these announcements, so it may require additional work for them to get the same results. We will see.

Ultimately, the range of criteria and some of the additional guidance from NICE potentially provide those who don’t want to spend the money to put blockers in the way, so we need to be prepared to deal with those.

And the opportunities?

As most readers of this article will be aware, the NHS in England has been undertaking the hybrid closed loop pilot this year, and the snippets of information revealed on social media and in discussions with clinicians suggest that the participants are seeing some fairly significant benefits in their outcomes.

Of course, you can’t use automated insulin delivery (AID) systems without rtCGM being available, so the introduction of NICE guidelines that make it clear that rtCGM is the best way to monitor glucose levels, and that it should be offered to everyone, opens the doors for this revolutionary technology. The new guideline references automated insulin delivery specifically in relation to CGM.

Could ace number four be the expansion of the closed loop trial and availability of AID to all those who need or want it? That’s not something I can answer. Similarly, open access to CGM via the NHS might potentially allow many more to utilise open source IAD systems, even if they can’t access commercial ones via their clinics, for whatever reasons.

So what do you think?

I think this is a huge step in getting rtCGM available to those who need or want it. It gives us an opportunity to push for it with our local services. We shouldn’t ignore that it’s going to present challenges to all of us and I don’t expect it to be an easy path, but with the right attitude to it, and the right support from organisations that campaign on our behalf, we can make it happen.

I don’t expect this to be a walk in the park, but it’s a big step in the right direction. It provides an enormous amount of power to challenge and cajole those who might be more reticent in offering it, and it gives us mechanisms to nationally look at what’s being done in relation to advancement of diabetes care and push it forward in the adult population. An area where focus has often been lacking.

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