FLASH GLUCOSE MONITORING SYSTEM - INCLUDING FREESTYLE LIBRE SOUTH WEST LONDON POSITION STATEMENT - INCLUDING FREESTYLE LIBRE ...
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Flash Glucose Monitoring System - (including FreeStyle Libre®)
South West London Position Statement
This position statement is not specific to Freestyle Libre and could be used for other Flash Glucose
Monitoring (Flash GM) devices which are approved for use in the future.
SW London CCGs* continue to work with local hospital diabetes teams to support the introduction of
Flash GM in line with the NHS England (NHS E) guidance. This can be found on the NHS website – click
here
South West London CCGs recommends that NHS funding of Flash GM device is only
considered for the patient groups listed below:
1. People who are clinically indicated as requiring intensive monitoring >8 times per day by their NHS
diabetes specialist, as demonstrated on a meter download/review over the past 3 months, AND
have
- Type 1 diabetes
OR
- With any form of diabetes on haemodialysis and on insulin treatment
2. People with diabetes associated with cystic fibrosis on insulin treatment.
3. Pregnant women with Type 1 Diabetes – 12 months in total inclusive of post-delivery period.
4. People with Type 1 diabetes unable to routinely self-monitor blood glucose due to disability who
require carers to support glucose monitoring and insulin management.
5. People with Type 1 diabetes for whom the specialist diabetes MDT determines have occupational
(e.g. working in insufficiently hygienic conditions to safely facilitate finger-prick testing) or
psychosocial circumstances that warrant a 6-month trial of Libre with appropriate adjunct support.
6. Previous self-funders of Flash Glucose Monitors with Type 1 diabetes where those with clinical
responsibility for their diabetes care are satisfied that their clinical history suggests that they
would have satisfied one or more of these criteria prior to them commencing use of Flash GM
had these criteria been in place prior to October 2019 AND has shown improvement in HbA1c
since self-funding.
7. For those with Type 1 diabetes and recurrent severe hypoglycaemia or impaired awareness of
hypoglycaemia, NICE suggests that Continuous Glucose Monitoring with an alarm is the
standard. Other evidence-based alternatives with NICE guidance or NICE TA support are pump
therapy, psychological support, structured education, islet transplantation and whole pancreas
transplantation. However, if the person with diabetes and their clinician consider that a Flash
GM system would be more appropriate for the individual’s specific situation, then this can be
considered.
The previous eligibility criteria for Freestyle Libre use in SW London, included the criterion
‘patients with an HbA1c >69mmol/mol (8.5%)’. Please note that this criterion is no longer covered
by NHS E funding, unless they meet one of the above criteria.
Trusts wishing to use Flash GM outside the above patient listed groups should follow their usual ‘non-
formulary request’ process and NOT request transfer of prescribing to GPs in primary care.
*SWL CCGs (Croydon CCG, Kingston CCG, Merton, CCG, Richmond CCG, Sutton CCG, & Wandsworth CCG)
Rajiv Dhir, Deputy Chief Pharmacist, Wandsworth CCG Produced: October 2019
1 Review date: October 2021Other requirements:
1. Education on Flash Glucose Monitoring has been provided (online or in person).
2. Agree to scan glucose levels no less than 8 times per day and use the sensor >70% of the time.
3. Agree to regular reviews with the local clinical team.
4. Previous attendance, or due consideration given to future attendance, at a Type 1 diabetes
structured education programme (DAFNE or equivalent if available locally)
Prescribing for long-term use following 6-month trial period of Flash Glucose Monitoring
After a period of 6-9 months trial of Flash GM, the specialist diabetes team will review the use of the
system with the patient. Flash GM will only be continued if there is evidence that on-going use of
Flash GM is demonstrably improving an individual’s diabetes self-management e.g. this may
include any one or more of the examples below;
• Improvement in HbA1c or time in range
• Improved commitment to regular scans and their use in self-management
• Reduction in testing strip usage e.g. safe and appropriate reduction of 8 a day for adults or 7 a day
for children
• Quality of life improvement using validated rating scales used by the specialist diabetes team
• Reduction in severe/non-severe hypoglycaemia
• Reduction in episodes of diabetic ketoacidosis
• Reduction in related admissions to hospital
• Reversal of impaired awareness of hypoglycaemia
Full details of the treatment outcomes must be documented and communicated to the GP so that GPs are
clear that the criteria for continuation have been met.
Users will be expected to actively engage with the service which is providing their diabetic care e.g.
attending all appointments. They must commit to training in the use of Flash GM, agree the expected
outcomes with usage e.g. reduction in the use of Blood Glucose Testing Strips (BGTS) – (approximate
target to be agreed*) or meeting one or more of the above criteria for continuation and agreeing that NHS
provision of Flash GM will be withdrawn if these criteria are not met.
It is recommended that if no improvement is demonstrated in one or more of these areas over a 6-
9-month trial then the use of Flash GM should be discontinued, and an alternative method of
monitoring used.
The specialist diabetes team will review the use of Flash GM systems at every clinical appointment to
make sure it is still suitable.
*In trials of Freestyle Libre, BGTS usage averaged 0.5 strips per day but it is acknowledged that use will be greater in some
circumstances e.g. illness, DVLA driving requirements (IMPACT study)
*SWL CCGs (Croydon CCG, Kingston CCG, Merton, CCG, Richmond CCG, Sutton CCG, & Wandsworth CCG)
Rajiv Dhir, Deputy Chief Pharmacist, Wandsworth CCG Produced: October 2019
2 Review date: October 2021Background
There is only one Flash GM currently manufactured - this is called the FreeStyle Libre®.
The FreeStyle Libre® system consists of a sensor worn on the upper arm that measures
interstitial glucose every minute and a wireless reader device that is scanned over the sensor to
get a result. Each time the reader device or compatible mobile phone is passed over the sensor,
glucose levels for the last eight hours are transferred to the device. It can produce a near
continuous record of glucose measurements which can be accessed on demand. It can also
indicate glucose level trends over time. The sensor is worn for 14 days, after that a new one
needs to be inserted. The sensors are available in SW London on NHS prescription to those who
meet the NHS E criteria.
The FreeStyle Libre system is indicated for measuring interstitial fluid glucose levels in people
(age 4 and older) with diabetes mellitus.
Although Flash GM will reduce the frequency of finger prick monitoring, it does not completely
remove the need for them. The diabetes specialist teams will advise when finger prick
monitoring should be done to patients and communicate to primary care clinicians an estimate
on how many test strips to reduce prescribing to – this will vary by individuals but is expected
to be lower than prior to using Flash GM.
Flash GM and Driving
Earlier this year, the DVLA (Driver and Vehicle Licensing Agency) updated their guidelines to
make testing requirements simpler for drivers with insulin treated diabetes. This means that
drivers of Group 1 vehicles (cars & motorcycles) may now use finger prick glucose testing or
Flash GM and real time Continuous Glucose Monitoring (CGM) systems for glucose monitoring
for the purpose of driving.
Group 2 drivers (bus and lorry) must continue to use finger prick testing for the purpose of
driving. Flash GM and real time continuous glucose monitoring systems are not legally permitted
for the purpose of Group 2 driving.
The DVLA guidance states that as there are times when Flash GM and real time continuous
glucose monitoring systems users are required to check their finger prick glucose, users of
these systems must also have finger prick glucose monitors and test strips available when
driving.
For full self-monitoring requirements, please contact the DVLA directly or visit their website. This
advice is subject to change/updates, so please do visit the DVLA website for the latest available
information.
Access to the DVLA website can be found here
*SWL CCGs (Croydon CCG, Kingston CCG, Merton, CCG, Richmond CCG, Sutton CCG, & Wandsworth CCG)
Rajiv Dhir, Deputy Chief Pharmacist, Wandsworth CCG Produced: October 2019
3 Review date: October 2021Blood Glucose Testing Strips (BGTS)
Users of Flash GM will still need to perform finger-prick blood tests during periods of illness,
rapidly changing interstitial glucose levels, or if hypoglycaemia or impending hypoglycaemia is
reported, where the symptoms do not match the reading and to meet current DVLA
requirements in certain circumstances as mentioned previously, Click here for full current
DVLA information.
Adjunct BGTS should be prescribed as per individual requirements with an expectation that
demand/frequency of supply will be reduced.
The BGTS used in the FreeStyle Libre reader (FreeStyle Optium blood glucose & ketone test
strips) are premium price. There is a need locally to make the best use of resources to benefit
the wider population, and whilst the use of BGTS will be reduced, all people using Freestyle
Libre flash GM/other Flash GM devices when available will be advised to use a suitable cost-
effective blood glucose testing meter and strip and not the premium price BGTS – please refer
to your local CCG guidance for preferred type1 meters and BGTS.
Out of Area Prescribing of Flash GM
The CCG will not commission the continuation of Flash GM commenced in the private
sector (self-funded) either in the UK or abroad. Only NHS specialist diabetes teams can
assess, provide training and agree to initiate sensors to patients who fulfill the NHS E criteria
for funding. If a patient is new to the Practice, please ensure that they have been assessed by
an NHS specialist diabetes team who have assessed their eligibility for NHS prescribing. If this
information and supporting documentation is not in place, then do not prescribe Flash GM on
the NHS. The Flash GM sensors are available to buy from any pharmacy for patients who do
not meet the criteria or who are awaiting an appointment with their specialist diabetes team.
Referral to the NHS diabetes specialist can be made, if it appears the eligibility criteria for
Flash GM will be met. The NHS diabetes specialist will assess Flash GM eligibility for NHS
prescribing at the next available routine appointment. Only when the GP Practice is in
receipt of the confirmation of eligibility, should the Flash GM sensors be prescribed.
In addition, at every diabetes review, the NHS specialist team will review the use of Flash GM
to make sure it is still suitable and confirm eligibility for continued funding.
Previous Guidance for Flash GM
Please note that NHS prescribing of Flash GM sensors will continue for patients who met the
previous SW London criteria for FreeStyle Libre® introduced in July 2018.
As of October 2019, all patients will need to meet the new NHS E Flash GM criteria as
described in this policy document, and this will replace the previous criteria which has now
been superseded
*SWL CCGs (Croydon CCG, Kingston CCG, Merton, CCG, Richmond CCG, Sutton CCG, & Wandsworth CCG)
Rajiv Dhir, Deputy Chief Pharmacist, Wandsworth CCG Produced: October 2019
4 Review date: October 2021Summary of Recommendation
• Flash GM is only recommended for prescribing on the NHS in South West London for the
patient groups listed in the box on page 1
• Assessment of NHS eligibility for Flash GM will be completed by the NHS diabetes specialist
teams through the existing routine out-patient appointments. This includes people currently self-
funding their own Flash GM system
• Initiation and prescribing for eligible patients will be the responsibility of specialist services for the
first 6 weeks before transfer of prescribing to primary care if criteria are met.
• People who are currently self-funding their own Flash GM system may be transferred to primary
care earlier than 6 weeks, if criteria are met and training has been provided
References & Acknowledgement
Flash Glucose Monitoring: National Arrangements for Funding of Relevant Diabetes Patients. NHS England March
2019
A guide to insulin treated diabetes and driving (INF294). Driver and Vehicle Licensing Agency (DVLA)
Guidance for the implementation of flash glucose monitoring prescribing in London - 01.05.2019. London Diabetes
Clinical Network and NHS London Procurement Partnership
South East London Area Prescribing Committee – Flash Glucose Monitoring systems
North Central London Joint Formulary Committee-Guidance for the implementation of flash glucose monitoring
prescribing in North Central London
Any comments relating to this guidance, e-mail Rajiv.dhir@swlondon.nhs.uk, Deputy Chief Pharmacist, Wandsworth
CCG.
*SWL CCGs (Croydon CCG, Kingston CCG, Merton, CCG, Richmond CCG, Sutton CCG, & Wandsworth CCG)
Rajiv Dhir, Deputy Chief Pharmacist, Wandsworth CCG Produced: October 2019
5 Review date: October 2021Flowchart for Managing Requests for Flash Glucose Monitoring System including- FreeStyle Libre®
Patient requests Flash GM from GP
• GPs should not initiate Flash GM sensors on the NHS
Flash GM • NHS diabetes specialist teams will assess both new & self-
not No Do they meet the NHS E funding criteria funding patients for NHS provision of a trial period with Flash
Indicated – (see position statement) GM at their next routine follow-up appointment
• Specialist team to provide/advise on NHS approved training in
the use of Flash GM to patients
Yes • Sensor and reader to be provided initially by NHS specialist
team for new patients for a 6-week period i.e. 3 sensors
• Prescribing to be transferred to GPs 6 weeks after initiation
• From week 6 to months 6 - 9 following initiation, GPs will only
NHS specialist diabetes team will discuss eligibility at next routine review continue prescribing upon receipt of the ‘initiation form’
appointment – it is not necessary to make a referral (exception, see key confirming the patient meets the approved eligibility criteria
points) • From week 6, GP should prescribe 2 sensors per month only on
an acute prescription
• After no more than 6- 9 months, a definitive decision regarding
ongoing prescribing of Flash GM sensors will be made by the
Flash GM
Patient meets one or more criteria NHS diabetes specialist team via the ‘continuation form’
not No • NHS diabetes specialist team will be responsible for monitoring
Indicated
& recording effectiveness of Flash GM
• The NHS will fund 26 sensors per year (1 sensor every 2 weeks)
Yes per patient. Do not prescribe sensors to replace faulty ones
• If a sensor is faulty or falls off the patient should contact the
Abbott Customer Careline, 0800 170 1177 to obtain replacement
sensors
Patient will be referred for NHS approved educational support and
then supplied with a scanner (reader) & 3 sensors (6-week supply) • For self-funding patients who meet eligibility & continuation
criteria, as assessed by an NHS diabetes specialist, their GPs
will be notified for continued prescribing via the ‘’continuation
form’
Specialist NHS Diabetic Service will be available for review 4-6 weeks after
initiation (this maybe by telephone/virtually) and then at 6-9 months
Specialist team 6-9 month review by NHS Specialist Team: The decision to continue will be made by
to confirm NHS diabetes specialist team only. It will be contingent upon evidence of agreeing with
discontinuation Specialist Team
‘other requirements’ listed on page 2 & that on-going use of the flash glucose Yes
& an alternative No to write to GPs
monitoring is demonstrably improving an individual’s diabetes self-management* e.g.
method of to confirm
improvement in HbA1c/ time in range, improvement in symptoms (DKA/hypoglycaemia),
monitoring continuation
or improvement in psycho-social wellbeing
*Note: These aims do not apply to people using flash glucose monitoring due to not having mental (e.g. learning disabilities) or physical capacity (e.g. manual dexterity problems which require a carer to do finger prick testing on their behalf) to undertake blood
glucose monitoring SWL CCGs (Croydon CCG, Kingston CCG, Merton, CCG, Richmond CCG, Sutton CCG, & Wandsworth CCG)
Rajiv Dhir, Deputy Chief Pharmacist, Wandsworth CCG Produced: October 2019
6 Review date: October 2021Key Points
• The decision to start Flash GM system will only be made by the NHS diabetes specialist team. New patients will undergo a trial period with Flash GM.
• GPs/primary care prescribers should not initiate Flash GM.
• Only patients who meet the eligibility criteria who are not under the care of an NHS diabetes specialist service need to be referred if requesting or could
benefit from Flash GM
• GPs/primary care prescribers should only continue prescribing the sensors if they have clear written communication from the NHS diabetes specialist team
• It is not anticipated that patients will require more than 26 sensors to be prescribed within a given year. It is recommended that no more than 2 sensors (1-
month supply) are prescribed at a time. If a patient is no longer able to check their glucose levels using Flash GM (permanently) advise them to revert to finger-
prick blood glucose testing and inform the initiating specialist.
• If a patient requires the sensor to be removed temporarily e.g. a patient is undergoing a planned procedure such as a CT scan/diathermy procedure which requires
the sensor to be removed they should be advised the following: Do not to apply a new sensor 14 days prior to the planned procedure and revert to finger
prick blood glucose testing. Do not apply a new sensor until Flash GM can be resumed.
• If a patient is not able to check their glucose levels using Flash GM (temporarily) for any reason, advise them to revert to finger prick blood glucose testing and not
to apply a new sensor until they can resume Flash GM as routine monitoring
• Review the number of Self-Monitoring Blood Glucose (SMBG) test strips prescribed in line with recommendations from the diabetes specialist team.
• If a GP has concerns about the effectiveness of Flash GM for an individual patient, they should contact the NHS specialist diabetes team.
Self-funding Flash GM
• There are patients who have already purchased and are using Flash GM - (self-funding). Patients who have obtained Flash GM through clinical trials or private
treatment, or who have been self-funding, must demonstrate that they satisfied the eligibility criteria for NHS funding of Flash GM when they commenced the use of
Flash GM as well as meeting the continuation criteria, to receive it on NHS prescription. They will need to be assessed and reviewed by the NHS diabetes specialist
team at their next planned specialist appointment
• Patients who are self-funding Flash GM and do not meet the criteria for initiation or continuation will not be entitled to NHS prescriptions. They may consider
continuing to purchase the ongoing sensors privately from a community pharmacy
• It is important to ensure that patients are made aware that prescribing decisions will not be based on what has already been purchased, but what has been agreed for
local NHS funding
Training
• Training materials are available to healthcare professionals in Primary care to support continuation of prescribing of Flash GM and understanding the device as part
of overall diabetes management (e.g. for discussion in annual reviews). Tutorial videos are available - click here and presentation – click here
• A document titled ‘FreeStyle Libre® primary care information sheet’ is available - click here
• For disposal please click here
Further Information
Further information associated with this policy is available through:
• the London Clinical Network website – click here
*SWL CCGs (Croydon CCG, Kingston CCG, Merton, CCG, Richmond CCG, Sutton CCG, & Wandsworth CCG)
Rajiv Dhir, Deputy Chief Pharmacist, Wandsworth CCG Produced: October 2019
7 Review date: October 2021Responsibilities for Specialist Teams and Primary Care
Pre-initiation Initiation Week 4-6 Month 6-9 Year 1 & then annually
• Identify eligible patients at • Provide patient training & initiate trial of Flash • Patient follow-up (can be done virtually) • Assessment of benefit (for • Notify GP of continued benefit
routine clinical appointments GM • Specialist team to review use/issues & long-term continuation) following annual review or inform the GP
in line with SW London • Inform GP of trial and send an 'Initiation form' check if on track for their 6-9 month against continuation criteria if treatment is to be discontinued
criteria for Flash GM •Request GP to continue prescribing the sensors continuation review • If trial successful: complete • Where patient does not attend
• Send GP 'Notification' letter from week 6 until specialist review in 6-9 months' • If patient is not continuing, specialist and send 'Continuation form' appointments, specialist team to liaise
time team to notify GP to GP highlighting whether with GP practice regarding ongoing
• Provide GPs with the expected number of SMBG continuation criteria have prescribing of Flash GM sensors
strips to be used per month been met & requesting GP to
Specialist
• Supply 3 sensors & reader for 6 weeks of continue prescribing sensors
responsibilities treatment • If trial unsuccessful:
Self-funding Request for GP to
• For patients who met the approved eligibility discontinue prescribing of
criteria, have self-funded & shown improvement Flash GM sensors
in HbA1c etc, GPs to be requested to take on long
term prescribing without a hospital supply
• Specialist team to complete & send
'Continuation form'
• Do not refer patients who • Do not initiate Flash GM for any patient • Only prescribe Flash GM sensors if the • Continue prescribing • Continue prescribing the sensors if
are already under an NHS patient's NHS diabetes specialist team has sensors if trial of Flash GM confirmation of continued benefit is
diabetes specialist service for confirmed the patient meets the approved has been successful. This received from the specialist following
the sole purpose of initiation eligibility criteria & on receipt of the must be confirmed by annual review
of Flash GM relevant completed forms (this includes specialist team confirming
Primary care new patients & patients who are self- continuation criteria has
responsibilities funding) been met.
• Discontinue prescribing of
sensors if trial has been
unsuccessful. The specialist
diabetes team will
communicate this
Prescribing of
Flash Glucose Specialist diabetes team prescribing Primary care acute prescription monthly until assessment of Repeat prescription if
(6 weeks) benefit by specialist - month 6-9 specialist confirms positive
sensors
assessment of benefit
Pre-initiation Initiation Week 6 Month 6 -9 Year 1 & then annually
Amended with permission from North Central London Joint Formulary Committee
*SWL CCGs (Croydon CCG, Kingston CCG, Merton, CCG, Richmond CCG, Sutton CCG, & Wandsworth CCG)
Rajiv Dhir, Deputy Chief Pharmacist, Wandsworth CCG Produced: October 2019
8 Review date: October 2021You can also read
