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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.
On completion of the trial, the specialist endocrinologist 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 specialist endocrinologists only) of the FreeStyle Libre:
1. Patients with:
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
2b. Attempts to achieve target HbA1c levels with multiple daily insulin injections results in the patient experiencing disabling hypoglycaemia
3. 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
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).
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.