November 2023 v1.1 

1.  Introduction 

People with diabetes on insulin need to regularly monitor their blood glucose levels to judge the amount of insulin they need to inject, to keep their blood glucose within an acceptable range and reduce the risk of short term and long term complications.

Historically, there were three main types of blood glucose monitoring: self-monitored blood glucose testing (using skin prick tests), real-time continuous glucose monitoring (rtCGM) and intermittently scanned continuous glucose monitoring (isCGM). isCGM is also sometimes known as ‘flash’. The only isCGM available in the UK (FreeStyle Libre 2) has now been upgraded to rtCGM, although it can still be used as an isCGM for patients who prefer this.

CGM devices can be divided into "low-cost” and "high-cost”. Low-cost CGM are those which cost <£1000 and are usually available to prescribe via a FP10. Formulary choices include FreeStyle Libre 2 and Dexcom ONE. These devices have sufficient functionality to meet the needs of most patients requiring CGM (see appendix 1). Higher cost CGM devices on the formulary include Dexcom G6 & G7, Medtronic 3 & 4. These have additional functionality which is appropriate for selected groups of patients. (see appendix 1)

This policy update adds eligibility criteria for each of the different high cost CGM devices available locally, to ensure that the most cost-effective, clinically appropriate device is selected. This is essential to support any future widening of access to CGM for adults.

 

2.  Content

Eligibility for CGM

 

The following cohorts are eligible for CGM:

• Adults with type 1 diabetes who are willing to commit to using CGM at least 70% of the time and to calibrate it as needed, and who have any of the following despite optimised use of insulin therapy and conventional blood glucose monitoring (As per the previous National Institute for Health and Care Excellence (NICE) guidance NG17 and criteria from NHS England (NHSE) 2019 Flash guidance):
  
  
• More than 1 episode a year of severe hypoglycaemia with no obviously preventable precipitating cause.
• Impaired or complete loss of awareness of hypoglycaemia.
• Frequent (more than 2 episodes a week) asymptomatic hypoglycaemia that is causing problems with daily activities.
• Extreme fear of hypoglycaemia.
• Are clinically indicated as requiring intensive monitoring >8 times daily, as demonstrated on a meter download/review over the past 3 months
• Are unable to self-monitor due to disability
• The specialist diabetes MDT determines have occupational or psychosocial circumstances that warrant a 6-month trial of CGM
• Are living with a learning disability and it is recorded on their GP Learning Disability register
• Are pregnant (12 months in total inclusive of post-delivery period)
  
  
• Adults with insulin treated type 2 diabetes who are living with a learning disability and it is recorded on their GP Learning Disability register (As per NHSE 2019 Flash guidance,)
  
  
• People with any form of diabetes on haemodialysis and on insulin treatment who are clinically indicated as requiring intensive monitoring >8 times daily, as demonstrated on a meter download/review over the past 3 months (As per NHSE 2019 Flash guidance,)
  
  
• People with diabetes associated with cystic fibrosis on insulin treatment (As per NHSE 2019 Flash guidance,)
  
   

The Dexcom ONE and FreeStyle Libre 2 have sufficient functionality to meet the needs of most patients requiring CGM. Both have customisable hypoglycaemia alerts, supporting those with impaired hypoglycaemia awareness. The Dexcom ONE is able to do repeat hypoglycaemia alerts (e.g. if hypoglycaemia continues or reoccurs within 15 mins). The FreeStyle Libre 2 does not do repeat hypoglycaemia alarms but, unlike the Dexcom ONE, does enable the user to share readings with others.

Initiation of CGM is via specialist diabetes teams only. Applications for low-cost CGM should be made by the specialist teams via the Blueteq drug management system. The devices can be prescribed via FP10.

 

Eligibility for high-cost CGM

Some patients will require additional functionality that is only available on high-cost CGM devices. To ensure the most cost-effective, clinically appropriate device is chosen, patients requiring a high-cost CGM device must meet both the eligibility criteria above for CGM and the criteria for the relevant high-cost CGM device.

After funding for high-cost CGM has been approved, if a patient’s circumstances change such that they are no longer eligible for a high cost device, they should be switched to a low cost device at the earliest opportunity, rather than at the end of the approved funding period.

 The following criteria are based on the additional functionality and cost of each device (see appendix 1).

 

Dexcom G7

The Dexcom G7 is the least expensive of the formulary high-cost devices. It is a newer device than the G6, with a smaller sensor, an all-in-one sensor and transmitter and a shorter warm up period. However, it does not yet have insulin pump connectivity. In addition to the functionality of the low-cost CGM devices, the Dexcom G7 has predictive alerts, which warn the wearer that they will be hypoglycaemic soon. These allow more time to act to prevent or self-treat hypoglycaemia. Like the Dexcom ONE, the G7 is able to do repeat hypoglycaemia alerts (e.g. if hypoglycaemia continues after the initial alert or reoccurs within 15 mins), but is also able to share readings.

 

Criteria:

• More than 1 episode in a year of severe hypoglycaemia (i.e. requiring 3rd party assistance) with no obviously preventable precipitating cause

• Frequent (more than 2 episodes a week) asymptomatic hypoglycaemia that is causing problems with daily activities.

• Extreme fear of hypoglycaemia that persists despite 6 months of low cost real-time CGM.

Dexcom G6
The only additional functionality of the Dexcom G6 over the G7 is insulin pump connectivity. Used with a compatible pump, the G6 can form a hybrid closed loop (HCL) or predictive low-glucose suspend (PLGS) sensor-augmented pump.  Although an older device, the Dexcom G6 is more expensive than the G7. 

Criteria:

-       Using an insulin pump which requires the G6 to create a hybrid closed loop (HCL) or predictive low-glucose suspend (PLGS) sensor-augmented pump.

-       Currently eligible for an insulin pump and intend to start pump therapy with a compatible pump within the next 3-6 months.

Medtronic 3 and Medtronic 4
The Medtronic 3 and 4 are not standalone CGMs and can only be used with the Medtronic pump as part of a low-glucose suspend (LGS) sensor-augmented pump, predictive low-glucose suspend (PLGS) sensor-augmented pump or hybrid closed loop (HCL) system.

Criteria:

-       Currently using or about to start a compatible Medtronic pump.

Other indications for high cost CGM
Sleeping through hypoglycaemia alarms is not an indication to switch to a higher-cost CGM. This is because manufacturer specifications do not indicate that higher cost CGM have louder alarms. Differences in smartphone devices may have more impact on alarm volume than the CGM device (and its corresponding app). Patients should be supported to ensure that their smartphone is optimally configured.

Funding for higher-cost CGM devices will be considered due to skin reactions to sensor adhesives where there is:

-       Significant, documented, contact dermatitis in response to sensor adhesives that cannot be managed otherwise (e.g. through use of barrier products)

-       Documented allergic reaction to sensor adhesive.

The lowest cost, clinically suitable device should be selected.

 

Indications outside of the criteria listed in this policy will be considered on an individual basis via the IFR route, with a review of the policy criteria if relevant additional cohorts are identified.

 

3.  Monitoring compliance

Diabetes technology is a rapidly changing area. This policy will be closely monitored and reviewed in response to significant changes, such as the publication of the NICE TA on hybrid closed loops expected in December 2023. 

Data to be monitored for all patients on CGM, and all patients eligible for CGM who have not taken it up:

• HbA1c
• Time in range
• Number of blood glucose testing strips (BGTS) used
• Hospital admissions for diabetes emergencies such as diabetic ketoacidosis (DKA) or severe hypoglycaemia.
• Episodes of severe hypoglycaemia which did not result in hospital admission.

 

We would expect to see an improvement in these indicators in patients on CGM. We would expect to see an improvement in HbA1c, an increase in time spent in range, and a reduction of BGTS used, hospital admissions and episodes of severe hypoglycaemia.

As per the 2022 NICE guidance regarding addressing inequalities in CGM access and uptake, other actions to be taken include:

• Monitoring who is using CGM – age, sex, ethnicity, deprivation
• Identifying groups who are eligible but have a lower uptake
• Making plans to engage with these groups to encourage them to consider CGM.  CITATION Nat22 \l 2057 (1) CITATION Nat221 \l 2057  (2) 

There should also be some qualitative data monitoring to capture insights on improvements in quality of life. The data collected using the above indicators and through qualitative methods will be used to evaluate the CGM policy and to inform decisions and next steps at future policy review stages.

 

4.  References

 

NHSE 2019 Flash guidance

 BIBLIOGRAPHY 1. National Insitute for Health and Care Excellence. Diabetes (type 1 and type 2) in children and young people: diagnosis and management. 2022.

2. National Insistute for Health and Care Excellence. Type 1 diabetes in adults: diagnosis and management. 2022.

3. National Institute for Health and Care Excellence. Type 2 diabetes in adults:management. 2022.

4. Digital, NHS. Quality and Outcomes Framework, 2020-21. 30 September 2021.

5. NHS Digital. National Diabetes Audit, 2020-21 Quarterly Report. 2021.

 

5.  Associated documentation

 

·        HWE ICB CGM Policy for adults and Paeds v1.0 FULL PAPER

·        HWE ICB CGM policy supplementary document

·        Prioritisation framework for HWE ICB CGM policy 2022

 

 

Appendix 1: Indicative Cost and Functionality of locally available CGM devices (at time of publishing).