The trial is to be initiated only by diabetes specialists. The specialist must inform the patient's GP of the indication under which the trial is commenced and the continuation criteria the patient must meet at their six month diabetes clinic review.
On completion of the trial, the diabetes specialist should undertake a review to assess suitability for continuation against the specified criteria. If the patient has achieved the indicated continuation criteria the specialist must inform the patient's GP to allow for continued prescribing in primary care. If the patient does not meet the specified continuation criteria, the specialist must stop the FreeStyle Libre, discuss this with the patient, and confirm this in writing to the patient and their GP.
The following patient groups with diabetes are eligible for a six month trial (to be initiated by diabetes specialists only) of the FreeStyle Libre:
1. Patients with:
- type 1 diabetes
- any form of diabetes on haemodialysis and who are on insulin treatment
- diabetes associated with cystic fibrosis who are on insulin treatment
- who, as a result of a clinical need, are self-monitoring their blood glucose 8 times or more per day as demonstrated on a meter download/review over the past 3 months
- Continuation criteria: Performing 8 or more scans a day and collecting 70% of daily data, and does not miss two consecutive specialist follow up appointments
2. Patients with type 1 diabetes who meet the following NICE criteria for insulin pump therapy:
2a. Have an HbA1c in excess of 8.5% on multiple daily injection insulin therapy despite a high level of care
- Continuation criteria: An HbA1c reduction of 0.5%, and does not miss two consecutive specialist follow up appointments
2b. Attempts to achieve target HbA1c levels with multiple daily insulin injections results in the patient experiencing disabling hypoglycaemia
- Continuation criteria: A reduction in hypoglycaemia frequency by more than one episode per week, and does not miss two consecutive specialist follow up appointments
3a. Patients with type 1 diabetes who are incapable of self-management of their diabetes due to their physical or mental health needs, and therefore require third party assistance to carry out glucose monitoring
- Continuation criteria:Performing 4 or more scans a day and collecting 70% of daily data, and does not miss two consecutive specialist follow up appointments
3b. Patients on insulin who are living with a learning disability, as recorded on their GP Learning disability register
- Continuation criteria: Performing 4 or more scans a day and collecting 70% of daily data, and does not miss two consecutive specialist follow up appointments
As the FreeStyle Libre has been commercially available prior to this commissioning policy, patients who have been self-funding or have received the FreeStyle Libre as part of a research project would be eligible for funding only if they met one of current criteria at the time they started using the device AND attained the appropriate continuation criteria after 6 months (as confirmed by diabetes specialists working for the NHS within Devon).
In addition, a 12 month use of the FreeStyle Libre is routinely commissioned in pregnant women with type 1 diabetes. During which time the patient is expected to perform 8 or more scans a day and collect 70% of daily data, and to not miss two consecutive specialist follow up appointments The 12 month period is inclusive of post-delivery period.
In the case of pregnant women with type 1 diabetes the specialist must inform the patient that the prescribing of the FreeStyle Libre is limited to 12 months and that it will not be routinely continued beyond that. This should also be confirmed in writing to the GP.
Following initial supply by specialist services, the GP should prescribe the FreeStyle Libre sensors (2 sensors required per month) for the duration of the six month trial, or for the 12 month period in pregnant women with type 1 diabetes.
GPs should consider reducing the number of testing strips and lancets the patient requires in combination with the FreeStyle Libre.
- FreeStyle Libre interstitial glucose sensor (£35 = one sensor, 14 days use)
- FreeStyle Libre 2 interstitial glucose sensor (£35 = one sensor, 14 days use)
Last updated: 13-05-2021
- Specialist initiation only with a review by specialists at 6 months (see continuation criteria, above)
- In the context of this entry, “diabetes specialist” refers to any suitably qualified member of the secondary care diabetes team
- Please refer to DVLA guidance regarding the use of interstitial glucose monitors when driving
- The FreeStyle Libre 2 sensor 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
- For LibreLink app users, alarms will not sound if their smartphone / mobile device is set to “vibrate only” or “do not disturb”
- For all users, self-monitored blood glucose (SMBG) tests are required when glucose readings and/or alarms do not match symptoms or expectations
- In addition, for users of the original FreeStyle Libre sensors, SMBG tests are required when the device indicates hypoglycaemia, impending hypoglycaemia, and during times of rapidly changing glucose levels
- The routine commissioning of FreeStyle Libre is accepted in Devon for patients with diabetes mellitus in line with specific criteria (see Commissioning Policy for more details)
- FreeStyle Libre is not routinely commissioned for use outside these patient groups
- 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)
- Patients with an existing Libre reader who require a FreeStyle Libre 2 reader can obtain a replacement device, free of charge, via the manufacturer’s website or by calling the patient care line above
- Local specialists have produced a patient information leaflet to support patients upgrading to the FreeStyle Libre 2 sensor. The leaflet is available here (under the header “Supporting you”)
- To prevent wastage, any switch to FreeStyle Libre 2 should be undertaken when the patient’s existing supply of Libre sensors runs out
6. Endocrine >
6.1 Drugs used in diabetes >
6.1.7 FreeStyle Libre / Libre 2 interstitial glucose monitor
- First line
- Second line