These sections briefly explain why the committee made the recommendations and how they might affect practice.
The evidence on real-time continuous glucose monitoring (rtCGM) showed it leads to:
a decrease in HbA1c and
an increase in time in range.
This reflected the committee's experience in clinical practice. They highlighted that the continuous nature of rtCGM, and the fact that it can be connected to the phone or device of a parent or carer so they can track the data, were particularly important components for children and young people.
Because the evidence showed similar benefits of rtCGM for children and young people as for adults, the committee extrapolated the cost-effectiveness results from adults, concluding that rtCGM was cost effective in this population.
The committee agreed that children and young people needed support to understand how CGM works, the accuracy of devices and the benefits it can provide, so they emphasised that rtCGM should be provided along with education on how to use it.
Intermittently scanned CGM (isCGM) had no clinically meaningful effect on any of the outcomes that were looked at in the evidence. In the committee's experience, the intermittent nature of isCGM can affect adherence in children and young people.
Since the same clinical benefits were not found for isCGM in children and young people as in adults, the committee agreed those cost-effectiveness findings could not be extrapolated, so they could not conclude that isCGM is a cost-effective technology for the full population of children and young people. They therefore agreed that isCGM should be restricted to children and young people who are unable or do not want to use rtCGM, or who would prefer isCGM. Children and young people who prefer isCGM are likely to have better adherence with this type of device, so it would provide more benefit. The recommendation limits isCGM to children aged 4 and over, because no isCGM devices are licensed in children under 4.
The committee did not make a recommendation on using specific devices because CGM technologies are changing very quickly and this recommendation would soon be out of date. Local healthcare services are better placed to assess which devices are evidence-based and suitable for use at any given time.
The committee wanted to highlight the importance of providing choice between the different CGM devices because the best device for each person would vary, so they produced a list of what to consider when discussing this with children and young people.
CGM should also be included in the continuing programme of education that children and young people with type 1 diabetes are offered. This will increase the likelihood that people will scan and report the results frequently, allowing them to understand and manage their diabetes effectively. In addition, children and young people should be supported by a team with expertise in using CGM. This will help them to use the technology effectively to manage their diabetes.
The committee made the recommendation about discussing possible problems with children and young people who are not using their device 70% of the time because it is important that the CGM device is used for a significant proportion of time for it to have a positive effect. They wanted to avoid a child or young person feeling 'punished' for using it less than that, but agreed that less than 70% use should trigger a discussion to find out if extra support is needed. While they did not make recommendations on stopping CGM, the committee acknowledged that it may not be offered as a permanent solution and that it can be stopped if it is not being used effectively or not perceived to be providing enough benefit.
Despite the positive recommendations on CGM, the committee were concerned that existing health inequalities may still lead to lower uptake of CGM in some groups of people. To address this, the committee made a recommendation outlining actions for commissioners, providers and healthcare professionals.
One of the known factors determining the use of CGM devices among children and young people with type 1 diabetes is sensitivities to the device, for example local skin reactions to the adhesive used in the sensor. The committee agreed that research is needed to investigate strategies to reduce local skin reactions to promote ease of use and adherence of these devices, so they made a recommendation for research on continuous glucose monitor sensor adhesive to prevent sensitivities.
The committee also made a recommendation for research using routinely collected real-world data to examine the effectiveness and cost effectiveness of CGM. They agreed that this has the potential to show the direct effects of implemented technology in children and young people instead of interpreting it through the results of clinical trials. Increased monitoring of routine healthcare data including registries and audits would ensure the findings from a broader population is captured.
An increasing number of children and young people with type 2 diabetes need to be catered for with specific guidance. There is currently a lack of evidence on the effectiveness of CGM in children and young people with type 2 diabetes. An adequately powered randomised controlled trial is needed to explore the effectiveness and cost effectiveness of rtCGM and isCGM compared with capillary blood glucose monitoring, so the committee made a recommendation for research on continuous glucose monitoring in children and young people with type 2 diabetes.
These recommendations are likely to result in broader access to rtCGM and isCGM devices for children and young people. This will increase costs but should reduce inequalities and enable more people to access the technology. Currently, children and young people and their parents and carers who have more time and knowledge to advocate or self-advocate are often more likely to gain access to these devices.
Some children and young people have insulin insufficiency because of other conditions. The committee noted that these children and young people would get the same care as children and young people with type 1 diabetes, so they should have access to CGM.
The 2015 recommendations caused some confusion around when to use oral or intravenous fluids. To address this, the committee looked for research evidence that would help them to make clearer recommendations. There was no evidence that compared different routes of administration or different oral fluids for hydration, so the committee updated the recommendations based on their experience and expertise.
In the 2015 guideline, the rate of fluid administration in diabetic ketoacidosis (DKA) was restricted because rapid fluid administration was believed to cause cerebral oedema. However, for the 2020 update there was some randomised controlled trial evidence (particularly the PECARN FLUID trial) comparing the effect of different DKA protocols on outcomes such as mortality or clinically apparent brain injury. This evidence showed no significant difference between the 2 protocols, and it demonstrated that the restrictions on the rate of fluid administration were not needed.
In response to this evidence, and applying their clinical expertise, the committee updated the recommendations to use more rapid fluid administration (including fluid boluses). They also made a separate recommendation for children and young people who are in shock, as this group need a higher volume of fluids, and they need these fluids to be given more rapidly.
When the 2015 recommendations were made, rapid fluid administration was believed to cause cerebral oedema. However, more recent randomised controlled trial evidence (particularly the PECARN FLUID trial) has shown that brain injury in this group may be caused by DKA itself, because of the resulting cerebral hypoperfusion, reperfusion and neuro-inflammation. If DKA is the cause of brain injury, children and young people would benefit from receiving more fluids in the first 48 hours than was recommended in the 2015 guideline. To address this, the committee updated the recommendation on calculating the fluid maintenance requirement, based on their clinical knowledge and on evidence from the PECARN FLUID trial. The Holliday-Segar formula that they recommended is commonly used in practice and has not been shown to cause any adverse events.
No evidence was identified on the use of potassium. The committee used their expertise and their understanding of the evidence on the pathophysiology of DKA to update the recommendation. They added more detail about how to care for children and young people with anuria or potassium levels above the normal range. It is essential to not delay adding potassium to fluids, because insulin can cause hypokalaemia in this population, which can lead to cardiac arrhythmias and death.
The committee also used their expertise to make recommendations highlighting complications such as hyperchloremic acidosis.
There is variation in practice due to the different beliefs on the causes of cerebral oedema. The new recommendations will be a change in practice in some areas, but they are in line with randomised trial evidence and with other clinical guidance (such as the International Society for Paediatric and Adolescent Diabetes DKA guideline).