The routine commissioning of continuous glucose monitors (CGMs) is accepted in Devon only in line with specific criteria; CGMs are not routinely commissioned for use outside these patient groups (refer to Commissioning Policy for initiation and continuation criteria).

A range of CGM devices are available, it is expected that a clinically appropriate device with the lowest cost is chosen (taking into account acquisition and ongoing running costs).

NICE advises that people who are using CGM (and their families or carers) will still need to take capillary blood glucose measurements to check the accuracy of their CGM device and as a back-up (for example when their blood glucose levels are changing quickly or if the device stops working), although they can do this less often. GPs should consider reducing the number of testing strips and lancets the patient requires in combination with a continuous glucose monitor.

Please refer to DVLA guidance regarding the use of CGM when driving.

MHRA Drug Safety Update (October 2024): Insulin pumps and continuous glucose monitoring (CGM) equipment: guidance for users on reporting suspected adverse incidents and safety concerns to the MHRA’s Yellow Card scheme

• The MHRA has published guidance to explain to users of all medical devices manufactured for diabetes management how to report safety concerns to the MHRA using the Yellow Card scheme.
• Healthcare professionals are asked to highlight the guidance to patients using insulin pumps, insulin pens and CGM devices.
• Remind patients that if they suspect a problem with their device, they should be advised to use an alternative method to manage their diabetes. See the safety update for advice to give to patients.

GP prescribable CGM

GP prescribable CGM is routinely commissioned for ALL patients with type 1 diabetes (or type 3c diabetes who are treated with insulin). This technology is also routinely commissioned for some patients with type 2 diabetes if they meet the eligibility criteria in the local commissioning policy.*

These devices are currently listed as amber meaning that diabetes specialist teams will usually initiate patients on the device (supply the initial sensor / transmitter and ensure that this is linked with the patient’s smartphone or reader device) and provide appropriate training and a route for ongoing support. Specialist teams initiating new patients on CGM should also ensure that the patient has sufficient sensors to last until the GP is able to provide ongoing prescriptions.

Whilst these devices are currently listed as amber, initiation of CGM by primary care professionals who are confident to do this without specialist input is accepted.

* The policy details that when available at the same cost as an intermittently scanned CGM, patients with type 2 diabetes may be offered a real time CGM. Intermittently scanned CGM devices are older forms of this technology which are now being discontinued by suppliers. As such it is expected that individuals with type 2 diabetes who meet the eligibility criteria in the CGM commissioning policy will be offered a GP prescribable real time CGM device which is suitable for their clinical needs with the lowest annual system running cost.

Guidance for users transitioning from Dexcom ONE to Dexcom ONE+

• Local diabetes specialists have advised that no formal additional user training should be required to facilitate the transition from Dexcom ONE to Dexcom ONE+.
• Patients should be advised that the Dexcom ONE+ system has an integrated transmitter. There is no need to prescribe separate transmitters with the Dexcom ONE+ system.
• Dexcom has produced a range of aids for users transitioning to Dexcom ONE+ which can be found using the links below:
  • Online user guide for Dexcom ONE+
  • Downloadable and printable Dexcom ONE to Dexcom ONE+ transition guide
• If a patient needs any additional support to aid this transition, Dexcom are offering free online nurse led training sessions which are bookable here.
• Alternatively, please contact the local diabetes specialist team who can arrange support for the transition to occur at the user’s next diabetes annual review.

Dexcom ONE+

• Interstitial glucose sensor (10 days use per sensor)
  • 1 x 10-day sensor with single use applicator, (£24.97 = one sensor, annual = £911.41)

Notes

1. This is a real time CGM device.
2. Can be used by people aged 2 years and older, including pregnant women.
3. If glucose alerts and readings from Dexcom ONE+ do not match symptoms or expectations, use a blood glucose monitor to make diabetes treatment decisions.
4. Device compatibility with the patient/carer’s smartphone or tablet can be checked on the manufacturer’s website
   1. If the patient/carer does not have a compatible smartphone or tablet, a separate reader device may be required. This should be supplied by the initiating clinician.
5. Some smartphone settings may prevent correct system operation; refer to manufacturer’s website / product user guide for more information.
6. Any patients who are experiencing issues with their sensor or reader should contact the Dexcom Technical Support Team using the Support Request Form via the Dexcom website (here) or by telephone on 0800 031 5761.
7. The routine commissioning of GP prescribable CGM is accepted in Devon for all patients with type 1 diabetes (or type 3c diabetes who are treated with insulin), and patients with type 2 diabetes who are treated with insulin and who meet the criteria specified in the policy (see Commissioning Policy for more details).

Dexcom ONE (existing users only)

• Interstitial glucose sensor (10 days use per sensor)
  • 1 x sensor with single use applicator, (£23.00 = one sensor, annual = £839.50)
  • 3 x sensors (plus 3 single use applicators) (£69.00 = 3 sensors, annual = £839.50)
• Transmitter (3 months use per transmitter)
  • 1 x transmitter (£18 per transmitter, annual = £74.00)
• Annual cost for comparison of this system (sensors plus transmitters) = £911.50

Notes

1. This system is due to be discontinued by May 2025. When appropriate, users should be transitioned to Dexcom ONE+ (see above).
2. This is a real time CGM device.
3. Can be used by people aged 2 years and older, including pregnant women.
4. If glucose alerts and readings from Dexcom ONE do not match symptoms or expectations, use a blood glucose monitor to make diabetes treatment decisions.
5. Device compatibility with the patient/carer’s smartphone or tablet can be checked on the manufacturer’s website
   1. If the patient/carer does not have a compatible smartphone or tablet, a separate reader device may be required. This should be supplied by the initiating clinician.
6. Some smartphone settings may prevent correct system operation; refer to manufacturer’s website / product user guide for more information.
7. Each SENSOR lasts for ten days.
8. The TRANSMITTER lasts for three months (it may be reused for multiple sensor sessions). Dexcom ONE tells users when the transmitter will need to be replaced, starting 3 weeks before.
9. Any patients who are experiencing issues with their sensor, transmitter or reader should contact the Dexcom Technical Support Team using the Support Request Form via the Dexcom website (here) or by telephone on 0800 031 5761.
10. The routine commissioning of GP prescribable CGM is accepted in Devon for all patients with type 1 diabetes (or type 3c diabetes who are treated with insulin), and patients with type 2 diabetes who are treated with insulin and who meet the criteria specified in the policy (see Commissioning Policy for more details).

Guidance for users transitioning from FreeStyle Libre 2 to FreeStyle Libre 2 Plus

• Local diabetes specialists have advised that no formal user training should be required to facilitate the transition from FreeStyle Libre 2 to FreeStyle Libre 2 Plus.
• Patients should be advised that the FreeStyle Libre 2 Plus sensor lasts for 15 days as opposed to 14 days (as per Freestyle Libre 2)
  • Users will receive an in app (or reader device) notification when the sensor is required to be changed.
• FreeStyle Libre 2 Plus will use the same app and login details as used for FreeStyle Libre 2.
• Abbott have produced the following resources which may aid this transition.
  • FreeStyle Libre 2 to FreeStyle Libre 2 plus transition guide (FOR CLINICIANS)
  • FreeStyle Libre 2 to FreeStyle Libre 2 plus transition guide (FOR PATIENTS)

FreeStyle Libre 2 Plus

• Interstitial glucose sensor (15 days use per sensor)
  • 1 x 15-days sensor with single use applicator (£37.50 = one sensor, annual = £912.50)

Notes

1. Can operate as a real time or intermittently scanned CGM device:
   1. When the FreeStyle Libre 2 reader is used this is an intermittently scanned CGM device
   2. When a mobile phone with the libre link app is used as the reader device this can provide real time glucose readings
   3. When used as part of a hybrid closed loop (HCL) system with the Omnipod 5 insulin pump, FreeStyle Libre 2 plus can provide real time glucose readings via the Omnipod 5 app.
2. Can be used by people aged 2 years and older, including pregnant women.
3. The FreeStyle Libre 2 plus system has the option of customisable, high and low glucose alarms (via the LibreLink app or Libre 2 reader); if using a Libre 2 reader device, once alerted by the alarm the patient must scan the sensor to get a glucose reading.
4. Some smartphone settings may prevent correct system operation; refer to manufacturer’s website / product user guide for more information.
5. A finger prick test using a blood glucose meter is required if a HI or LO reading appears on the reader or if glucose readings and alarms do not match symptoms or expectations (refer to user manual).
6. Any patients who are experiencing issues with their sensor or reader should contact Abbott Diabetes care directly for a replacement (Manufacturer contact number/patient care line: 0800 170 1177).
   
7. The routine commissioning of GP prescribable CGM is accepted in Devon for all patients with type 1 diabetes (or type 3c diabetes who are treated with insulin), and patients with type 2 diabetes who are treated with insulin and who meet the criteria specified in the policy (see Commissioning Policy for more details).

FreeStyle Libre 2 (existing users only)

• Interstitial glucose sensor (14 days use per sensor)
  • 1 x 14-days sensor with single use applicator (£35.00 = one sensor, 28 days = £70.00, annual = £912.50)

Notes

1. This system is due to be discontinued by June 2025. When appropriate, users should be transitioned to FreeStyle Libre 2 Plus (see above).
2. This is an intermittently scanned CGM device.
3. Can be used by people aged 4 years and older, including pregnant women.
4. The FreeStyle Libre 2 system has the option of customisable, high and low glucose alarms (via the LibreLink app or Libre 2 reader); once alerted by the alarm the patient must scan the sensor to get a glucose reading.
5. Some smartphone settings may prevent correct system operation; refer to manufacturer’s website / product user guide for more information.
6. A finger prick test using a blood glucose meter is required if a HI or LO reading appears on the reader or if glucose readings and alarms do not match symptoms or expectations (refer to user manual).
7. Any patients who are experiencing issues with their sensor or reader should contact Abbott Diabetes care directly for a replacement (Manufacturer contact number/patient care line: 0800 170 1177).
8. The routine commissioning of GP prescribable CGM is accepted in Devon for all patients with type 1 diabetes (or type 3c diabetes who are treated with insulin), and patients with type 2 diabetes who are treated with insulin and who meet the criteria specified in the policy (see Commissioning Policy for more details).

FreeStyle Libre 3

• Interstitial glucose sensor (14 days use per sensor)
  • 1 x 14-days sensor with single use applicator (£42.00 = one sensor, annual = £1,095)

Notes

1. Only recommended for use as part of a hybrid closed loop (HCL) system (alongside the mylife Ypsopump and CamAPS FX algorithm) in pregnancy in line with NICE TA943.
2. Not recommended for use as stand-alone CGM.
3. For real time glucose alerts to be received the users mobile phone settings should allow for notifications and the sensor must be within 33 feet unobstructed of the reading device.
4. Some smartphone settings may prevent correct system operation; refer to manufacturer’s website / product user guide for more information.
5. A finger prick test using a blood glucose meter is required if a HI or LO reading appears on the reader or if glucose readings and alarms do not match symptoms or expectations (refer to user manual).
6. Any patients who are experiencing issues with their sensor or reader should contact Abbott Diabetes care directly for a replacement (Manufacturer contact number/patient care line: 0800 170 1177).

Secondary care procured real-time CGM (rtCGM)

A range of rtCGM devices are available, it is expected that a clinically appropriate device with the lowest cost is chosen (taking into account acquisition and ongoing running costs).

A 6-month trial of a secondary care procured rtCGM is routinely commissioned only for patients with type 1 diabetes (or type 3c diabetes who are treated with insulin) who meet one or more of the criteria specified in the Commissioning Policy.

The Commissioning policy also details specific continuation criteria which must be met in order for continued use of a secondary care procured (non-GP prescribable) rtCGM device.

It is expected that at each review consideration is given to stepping down to lower cost (e.g GP prescribable) forms of glucose monitoring wherever clinically appropriate or where the ability to recognise and/or communicate about symptoms of hypoglycaemia has significantly improved.

These devices are only available via the secondary care NHS supply chain; GPs are unable to prescribe these devices.

MHRA Device Safety Information (May 2021): Dexcom G6 Sensor: Untested barrier methods to reduce skin reactions:

1. Some users of the Dexcom G6 continuous glucose monitoring system have experienced adverse skin reactions under the sensor, including hypersensitivity reactions.
2. Use of barrier methods or patches is not recommended as this may affect the performance of the device.
3. Identify patients who have skin reactions and consider whether continued use of this device is suitable for these patients. Consider use of alternative glucose monitoring systems for these patients.
4. Report skin reactions to the device manufacturer and through your healthcare institution’s local incident reporting system and/or the national incident reporting authority