Amity Island
Well-Known Member
- Relationship to Diabetes
- Type 1
I'd imagine a similar set of guidelines here in rest of the UK.
Here it is for anyone who can't download and open it.
Pathway for the Managed Access of FreeStyle Libre® (Flash Glucose monitoring) for Adults and Children in the care of Trust Specialist Diabetes Clinics in Northern Ireland
This pathway is for use by secondary care diabetes health care professionals, to assess if patients are suitable for a trial period of the FreeStyle Libre® system or for supply of sensors on prescription (for those who have previously been self-funding). It does not cover assessment of patients for continuous glucose monitoring. The pathway provides criteria and additional points for consideration to support clinical decision making processes. The application of the points for consideration will be dependent upon clinical judgement and individual patient circumstances.
Note: The use of FreeStyle Libre® in pregnancy is outside the scope of this pathway
Criteria for a 3-6 month trial of FreeStyle Libre®
(NOTE: These criteria must also be met when establishing if patients who have been self- funding are now eligible for supply of sensors on prescription).
1) Type 1 Diabetes.
2) Have undergone (or willing to undertake) previous ‘advanced insulin self-management education’ e.g. DAFNE, BERTIE, CHOICE.
Additional clinical points to be considered:
3) Utilising effective basal bolus insulin self-management with evidence of CHO counting and correction insulin use with an SMBG frequency of >4 tests daily.
4) Problematic BG Control or difficulties maintaining good control, despite the above e.g.
a. Variable SMBG control with episodic hypoglycaemia impacting on lifestyle.
b. Recurrent hypoglycaemia (> 3 episodes per week or >2 severe episodes in a year).
c. Loss of hypoglycaemia Awareness Symptoms (‘Modified Clarke and Gold Score’ >4; NICE NG17. See Appendix 1).
d. Persistent Elevation of HbA1c despite insulin dose adjustments.
e. Severe physical, psychological or occupational barriers to effective SMBG.
5) Substantial evidence of benefit in maintaining good glucose control with a sensor device.
6) Regular attendance at secondary care clinic.
Action Pathway (for patients assessed as suitable for a trial of FreeStyle Libre®)
Initial assessments.
Full examination and biochemical assessment of potential confounders of control (e.g. thyroid/adrenal/coeliac assessment).
SMBG control or Diagnostic (Professional) CGM (iPro or equivalent) as a baseline assessment.
All outcomes of assessments and clinical results should be recorded in the patient’s medical notes.
Consent and Training
For first time users of FreeStyle Libre®
Patient consent obtained to ensure that they wish to trial the FreeStyle Libre® system.
Patient referred to clinic for training.
Attendance at training confirmed and patient still wishes to proceed.
Patient supplied with FreeStyle Libre® reader and starter pack of sensors at training clinic.
For ALL patients (including those who have previously self-funded FreeStyle Libre®)
Patients to be informed that they will be reviewed in 3-6 months, to assess if they have met the criteria for ongoing use of FreeStyle Libre®.
Patient’s current method of testing blood glucose and/or blood ketones to be reviewed. Note: The FreeStyle Libre® reader has a built in port to enable blood glucose and ketone testing. This requires use of FreeStyle Optium® blood glucose test strips and FreeStyle Optium β Ketone® strips, which are NOT cost effective choices of blood glucose and ketone strips. (see price lists in appendix 6). Patients should therefore be given separate glucometer(s), which, where possible use cost effective blood glucose strips; <£10 for 50 and cost effective ketone test strips <£10 for 10, to use alongside FreeStyle Libre®.
Patient provided with patient information leaflet (see sample leaflets; appendix 4 and 5). This should explain the process for review, so that the patients understand, from the outset that prescribing may not continue if criteria are not met and also details of what to do if they receive a faulty sensor i.e. contact Abbott Manufacturer;
Customer Service Telephone number: 0800 1701177 (Mon – Fri 8am -8pm) excluding bank holidays).
GP Communication
Letter to be issued from the training clinic to patients GP. Letter to outline the following: (see sample letters in appendix; 2 and 3).
Patient has met the criteria for a 3-6 month trial of FreeStyle Libre® or is now eligible to receive sensors on prescription, after previously self- funding.
Patient has received training on the device.
If the patient is less than 4 years old, GP to be informed that use of FreeStyle Libre® is off licence. Clarification obtained from GP that they are willing to undertake prescribing.
First time users have been supplied with FreeStyle Libre® reader and starter pack of sensors
Request GP to issue prescriptions for FreeStyle Libre® sensors (maximum 2 per month).
Inform GP of the patient’s review date for assessment of continued use.
Inform GP of the name of blood glucose test strips (and ketone strips, if appropriate), which will be used alongside the FreeStyle Libre® system.
Inform GP that they should contact secondary care at any time, if they are concerned as to the appropriateness of the continued use of FreeStyle Libre® system for a particular patient.
Review criteria
Ideally 3 monthly assessments (with regular data upload) whilst on trial to confirm:
1) Use of each sensor for at least 70% of the time.
2) Effect of sensor use on reduction of BG variability and increase of percentage of time spent in target BG range (4-10mmol/L) compared to baseline
3) Improvement in the initial problem triggering the trial.
If all 3 criteria are achieved, then approve continued use of sensors (reviewed annually) with expectation of ongoing regular contact and sensor upload by diabetes specialist team.
If use is suboptimal or does not result in effective change then sensor supply withdrawn and alternative avenues for the assistance of the individual are assessed.
4) Patient’s GP to be informed by letter of outcome of the review. Advised to cease or continue prescribing of FreeStyle Libre® sensors.
Specialist Clinic Reporting to Diabetes Network Technology sub group
1) Quarterly report of numbers of patients assessed by GP practice
2) Quarterly report of numbers of patients offered a 3-6 month trials.
3) Quarterly report of numbers of trial successful and numbers of established users continuing effective use (after year 1).
Audit
Trusts will undertake to carry out regular audits to ensure that the pathway has been appropriately applied, with results reported to the Technology Subgroup. Initial audit to be undertaken after 6 months and annually thereafter.
Review
This pathway will be reviewed as further clinical evidence for FreeStyle Libre® becomes available or guidance is issued by NICE.
Here it is for anyone who can't download and open it.
Pathway for the Managed Access of FreeStyle Libre® (Flash Glucose monitoring) for Adults and Children in the care of Trust Specialist Diabetes Clinics in Northern Ireland
This pathway is for use by secondary care diabetes health care professionals, to assess if patients are suitable for a trial period of the FreeStyle Libre® system or for supply of sensors on prescription (for those who have previously been self-funding). It does not cover assessment of patients for continuous glucose monitoring. The pathway provides criteria and additional points for consideration to support clinical decision making processes. The application of the points for consideration will be dependent upon clinical judgement and individual patient circumstances.
Note: The use of FreeStyle Libre® in pregnancy is outside the scope of this pathway
Criteria for a 3-6 month trial of FreeStyle Libre®
(NOTE: These criteria must also be met when establishing if patients who have been self- funding are now eligible for supply of sensors on prescription).
1) Type 1 Diabetes.
2) Have undergone (or willing to undertake) previous ‘advanced insulin self-management education’ e.g. DAFNE, BERTIE, CHOICE.
Additional clinical points to be considered:
3) Utilising effective basal bolus insulin self-management with evidence of CHO counting and correction insulin use with an SMBG frequency of >4 tests daily.
4) Problematic BG Control or difficulties maintaining good control, despite the above e.g.
a. Variable SMBG control with episodic hypoglycaemia impacting on lifestyle.
b. Recurrent hypoglycaemia (> 3 episodes per week or >2 severe episodes in a year).
c. Loss of hypoglycaemia Awareness Symptoms (‘Modified Clarke and Gold Score’ >4; NICE NG17. See Appendix 1).
d. Persistent Elevation of HbA1c despite insulin dose adjustments.
e. Severe physical, psychological or occupational barriers to effective SMBG.
5) Substantial evidence of benefit in maintaining good glucose control with a sensor device.
6) Regular attendance at secondary care clinic.
Action Pathway (for patients assessed as suitable for a trial of FreeStyle Libre®)
Initial assessments.
Full examination and biochemical assessment of potential confounders of control (e.g. thyroid/adrenal/coeliac assessment).
SMBG control or Diagnostic (Professional) CGM (iPro or equivalent) as a baseline assessment.
All outcomes of assessments and clinical results should be recorded in the patient’s medical notes.
Consent and Training
For first time users of FreeStyle Libre®
Patient consent obtained to ensure that they wish to trial the FreeStyle Libre® system.
Patient referred to clinic for training.
Attendance at training confirmed and patient still wishes to proceed.
Patient supplied with FreeStyle Libre® reader and starter pack of sensors at training clinic.
For ALL patients (including those who have previously self-funded FreeStyle Libre®)
Patients to be informed that they will be reviewed in 3-6 months, to assess if they have met the criteria for ongoing use of FreeStyle Libre®.
Patient’s current method of testing blood glucose and/or blood ketones to be reviewed. Note: The FreeStyle Libre® reader has a built in port to enable blood glucose and ketone testing. This requires use of FreeStyle Optium® blood glucose test strips and FreeStyle Optium β Ketone® strips, which are NOT cost effective choices of blood glucose and ketone strips. (see price lists in appendix 6). Patients should therefore be given separate glucometer(s), which, where possible use cost effective blood glucose strips; <£10 for 50 and cost effective ketone test strips <£10 for 10, to use alongside FreeStyle Libre®.
Patient provided with patient information leaflet (see sample leaflets; appendix 4 and 5). This should explain the process for review, so that the patients understand, from the outset that prescribing may not continue if criteria are not met and also details of what to do if they receive a faulty sensor i.e. contact Abbott Manufacturer;
Customer Service Telephone number: 0800 1701177 (Mon – Fri 8am -8pm) excluding bank holidays).
GP Communication
Letter to be issued from the training clinic to patients GP. Letter to outline the following: (see sample letters in appendix; 2 and 3).
Patient has met the criteria for a 3-6 month trial of FreeStyle Libre® or is now eligible to receive sensors on prescription, after previously self- funding.
Patient has received training on the device.
If the patient is less than 4 years old, GP to be informed that use of FreeStyle Libre® is off licence. Clarification obtained from GP that they are willing to undertake prescribing.
First time users have been supplied with FreeStyle Libre® reader and starter pack of sensors
Request GP to issue prescriptions for FreeStyle Libre® sensors (maximum 2 per month).
Inform GP of the patient’s review date for assessment of continued use.
Inform GP of the name of blood glucose test strips (and ketone strips, if appropriate), which will be used alongside the FreeStyle Libre® system.
Inform GP that they should contact secondary care at any time, if they are concerned as to the appropriateness of the continued use of FreeStyle Libre® system for a particular patient.
Review criteria
Ideally 3 monthly assessments (with regular data upload) whilst on trial to confirm:
1) Use of each sensor for at least 70% of the time.
2) Effect of sensor use on reduction of BG variability and increase of percentage of time spent in target BG range (4-10mmol/L) compared to baseline
3) Improvement in the initial problem triggering the trial.
If all 3 criteria are achieved, then approve continued use of sensors (reviewed annually) with expectation of ongoing regular contact and sensor upload by diabetes specialist team.
If use is suboptimal or does not result in effective change then sensor supply withdrawn and alternative avenues for the assistance of the individual are assessed.
4) Patient’s GP to be informed by letter of outcome of the review. Advised to cease or continue prescribing of FreeStyle Libre® sensors.
Specialist Clinic Reporting to Diabetes Network Technology sub group
1) Quarterly report of numbers of patients assessed by GP practice
2) Quarterly report of numbers of patients offered a 3-6 month trials.
3) Quarterly report of numbers of trial successful and numbers of established users continuing effective use (after year 1).
Audit
Trusts will undertake to carry out regular audits to ensure that the pathway has been appropriately applied, with results reported to the Technology Subgroup. Initial audit to be undertaken after 6 months and annually thereafter.
Review
This pathway will be reviewed as further clinical evidence for FreeStyle Libre® becomes available or guidance is issued by NICE.
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