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The following patient groups with type 1 diabetes are eligible for a six month trial (to be initiated by specialist endocrinologists only) of the FreeStyle Libre:
1. Patients who, as a result of a clinical need, are self-monitoring their blood glucose 8 times or more per day
2. Patients 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
2b. Attempts to achieve target HbA1c levels with multiple daily insulin injections results in the patient experiencing disabling hypoglycaemia
3. Patients 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
The trial is to be initiated only by specialist endocrinologists. 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.
Following initial supply by specialist services, the GP should prescribe the FreeStyle Libre sensors for the duration of the six month trial (2 sensors required per month). GPs should consider reducing the number of testing strips and lancets the patient requires in combination with the FreeStyle Libre during this trial period.
On completion of the trial, the specialist endocrinologist should undertake 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.
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 specialist endocrinologists working for the NHS within Devon).