Diabetes Mellitus - diagnostic and monitoring agents

Prescribing Notes:

• Continuous glucose monitoring covers real-time continuous glucose monitoring (rtCGM).
• Continuous glucose monitoring may also be considered for pregnant women with type 1 diabetes in line with Scottish Health Technology Guidance (SHTG).
• The MHRA has produced guidance for users on reporting suspected adverse incidents and safety concerns with insulin pumps and continuous glucose monitoring (CGM) equipment to help thoroughly investigate potential safety issues.

Freestyle Libre 2 and 2 Plus

• Freestyle Libre 2 and 2 Plus are real time glucose monitoring systems which monitor interstitial fluid glucose levels via a sensor. Both sensors are compatible with the Freestyle Libre 2 reader, which has a built-in meter that supports testing of capillary blood glucose and capillary blood ketone levels using the corresponding test strips (Freestyle Optium blood glucose and Freestyle Optium β Ketone test strips respectively).
• All individuals on Libre 2 or 2 Plus will require the facility to use finger prick blood glucose and ketone testing on occasion (e.g. during periods of intercurrent illness). Freestyle Optium blood glucose and Freestyle Optium beta ketone can be used with the Libre 2 reader or patients can be supplied and trained on an alternative meter for this purpose. FreeStyle Libre 2 or 2 Plus should only be initiated under the advice and ongoing supervision of the specialist diabetes team in line with Scottish Diabetes Group guidance.
• Patients will only be provided with 26 FreeStyle Libre 2 sensors for a year’s supply. If they require any further sensors due to failure of the device then they must contact the company directly and report to the MHRA via the Yellow card scheme.
• Patients will only be provided with 25 FreeStyle Libre 2 Plus sensors for a year's supply. If they require any further sensors due to failure of the device, then they must contact the company directly and report to the MHRA via the Yellow card scheme.
• Freestyle Libre 2 Plus is compatible with Omnipod 5 Automated Insulin Delivery System.

Dexcom One+

• Dexcom one+ is a continuous glucose monitoring system which monitors interstitial fluid glucose levels via a sensor.
• All individuals on Dexcom one+ will require the facility to use finger prick blood glucose and ketone testing on occasion (e.g. during periods of intercurrent illness). Patients can be supplied and trained on an alternative meter for this purpose. Dexcom one+ should only be initiated under the advice and ongoing supervision of the specialist diabetes team in line with the same criteria as Scottish Diabetes Group guidance for flash glucose monitoring. Dexcom one+ is reserved as second line for patients who have experienced difficulties with Freestyle Libre 2 (e.g. adhesive issues, problems with accuracy or alarms).
• Patients will only be provided with 36-37 Dexcom One+ sensors for a year’s supply. If they require any further sensors due to failure of the device, then they must contact the company directly and report to the MHRA via the Yellow card scheme.

Prescribing Notes:

• People with diabetes treated with insulin must be guided by their diabetes healthcare professional when choosing a suitable blood glucose meter. Many meters now assist with carbohydrate counting, blood glucose pattern management and blood ketone testing and the first choice meter may not meet the requirements of this patient group.
• Correct meter care and quality control are essential when meters are used.
• Meters are obtainable from diabetes clinics with expert advice from a suitably trained person.
• Strips deteriorate rapidly if exposed to the atmosphere.
• Some people with diabetes may require a specialist meter taking in individual factors and following assessment by specialist diabetes team. It is the responsibility of the specialist team to document and highlight these requests to the referring primary care team.

Prescribing Notes:

• Do not routinely offer self-monitoring of blood glucose levels for people with type 2 diabetes.
• Self blood glucose monitoring need not be performed by:
  • those treated by diet and physical activity alone;
  • those whose control is stable and appropriate for that patient as indicated by HbA_1c;
  • those at low risk of hypoglycaemia e.g. those treated with metformin, glitazones, gliptins, (SGLT2) inhibitors or GLP-1 agonists.
  • In these cases, a six-monthly estimate of HbA_1c is adequate to monitor glycaemic control.
• Self blood glucose monitoring in people with Type 2 diabetes should be undertaken only:
  • when insulin is prescribed, whether or not this is combined with oral medication for diabetes;
  • to monitor for hypoglycaemia due to treatment with sulphonylureas or other antidiabetic drugs that risk hypoglycaemia;
  • to ensure safe blood-glucose concentrations during activities such as driving/operating machinery;
  • to monitor changes to blood-glucose concentrations due to changes in treatment, lifestyle or acute illness, such as steroid induced diabetes;
  • for people with type 2 diabetes who are planning pregnancy and during pregnancy.
  • In most cases, blood glucose monitoring should not require to be performed routinely. The timing of the samples will depend on the particular case. People with diabetes must be aware of how to interpret the results and what action to take on the results obtained. Education is an essential component of self-monitoring of blood glucose.
• If routine self-monitoring of blood glucose is indicated, ensure that an assessment is carried out at least annually.
• People with diabetes treated with insulin must be guided by their diabetes healthcare professional when choosing a suitable blood glucose meter. Many meters now assist with carbohydrate counting, blood glucose pattern management and blood ketone testing and the first choice meter may not meet the requirements of this patient group.
• Correct meter care and quality control are essential when meters are used.
• Meters are obtainable from diabetes clinics with expert advice from a suitably trained person.
• Strips deteriorate rapidly if exposed to the atmosphere.
• Some people with diabetes may require a specialist meter taking in individual factors and following assessment by specialist diabetes team. It is the responsibility of the specialist team to document and highlight these requests to the referring primary care team.

Prescribing Notes:

• Self-monitoring of blood glucose levels may also be used for people with gestational diabetes.
• Correct meter care and quality control are essential when meters are used.
• Meters are obtainable from diabetes clinics with expert advice from a suitably trained person.
• Strips deteriorate rapidly if exposed to the atmosphere.
• Some patients may require a specialist meter taking in individual factors and following assessment by specialist diabetes team. It is the responsibility of the specialist team to document and highlight these requests to the referring primary care team.

Prescribing Notes:

• Do not routinely offer self-monitoring of blood glucose levels for people with type 2 diabetes.
• Self blood glucose monitoring need not be performed by:
  • those treated by diet and physical activity alone;
  • those whose control is stable and appropriate for that patient as indicated by HbA_1c;
  • those at low risk of hypoglycaemia e.g. those treated with metformin, glitazones, gliptins, (SGLT2) inhibitors or GLP-1 agonists.
  • In these cases, a six-monthly estimate of HbA1c is adequate to monitor glycaemic control.
• Self blood glucose monitoring in people with Type 2 diabetes should be undertaken only:
  • when insulin is prescribed, whether or not this is combined with oral medication for diabetes;
  • to monitor for hypoglycaemia due to treatment with sulphonylureas or other antidiabetic drugs that risk hypoglycaemia;
  • there is evidence of hypoglycaemic episodes;
  • to ensure safe blood-glucose concentrations during activities such as driving/operating machinery;
  • to monitor changes to blood-glucose concentrations due to changes in treatment, lifestyle or acute illness, such as steroid induced diabetes.
  • In most cases, blood glucose monitoring should not require to be performed routinely. The timing of the samples will depend on the particular case. People with diabetes must be aware of how to interpret the results and what action to take on the results obtained. Education is an essential component of self-monitoring of blood glucose.
• If routine self-monitoring of blood glucose is indicated, ensure that an assessment is carried out at least annually.
• People with diabetes treated with insulin must be guided by their diabetes healthcare professional when choosing a suitable blood glucose meter. Many meters now assist with carbohydrate counting, blood glucose pattern management and blood ketone testing and the first choice meter may not meet the requirements of this patient group.
• Correct meter care and quality control are essential when meters are used.
• Meters are obtainable from diabetes clinics with expert advice from a suitably trained person.
• Strips deteriorate rapidly if exposed to the atmosphere.
• Some people with diabetes may require a specialist meter taking in individual factors and following assessment by specialist diabetes team. It is the responsibility of the specialist team to document and highlight these requests to the referring primary care team.

Prescribing Notes:

• Correct meter care and quality control are essential when meters are used.
• Meters are obtainable from diabetes clinics with expert advice from a suitably trained person.
• Strips deteriorate rapidly if exposed to the atmosphere.
• Some patients may require a specialist meter taking in individual factors and following assessment by specialist diabetes team. It is the responsibility of the specialist team to document and highlight these requests to the referring primary care team.

Prescribing Notes:

• Please note that the Accu-Chek Performa meter has been discontinued, however the testing strips continue to be available.

Prescribing Notes:

• It is important to test for blood ketones where there is significant risk of diabetic ketoacidosis (DKA), such as people with type 1 diabetes with intercurrent illness, during pregnancy and when using insulin pump therapy.
• People with diabetes, and where appropriate, their carers must be aware of when to test and how to interpret the results including when to seek medical attention.
• FreeStyle Libre 2 has a built in meter that supports testing of blood ketones using FreeStyle Optium β Ketone Test Strips.
• Blood ketone testing is the most accurate form of testing and should only be undertaken on specialist advice.
• Self-monitoring of blood ketones is not recommended when patients are prescribed an SGLT-2 inhibitor. However, GP surgeries and acute settings can still carry out this monitoring if required.

Prescribing Notes:

• Continuous glucose monitoring covers real-time continuous glucose monitoring (rtCGM).
• Continuous glucose monitoring may also be considered for pregnant women with type 1 diabetes in line with Scottish Health Technology Guidance (SHTG).
• The MHRA has produced guidance for users on reporting suspected adverse incidents and safety concerns with insulin pumps and continuous glucose monitoring (CGM) equipment.

Freestyle Libre 2 and 2 Plus

• Freestyle Libre 2 and 2 Plus are real time glucose monitoring systems which monitor interstitial fluid glucose levels via a sensor. Both sensors are compatible with the Freestyle Libre 2 reader, which has a built in meter that supports testing of capillary blood glucose and capillary blood ketone levels using the corresponding test strips (Freestyle Optium blood glucose and Freestyle Optium β Ketone test strips respectively).
• All individuals on Libre 2 or 2 Plus will require the facility to use finger prick blood glucose and ketone testing on occasion (e.g. during periods of intercurrent illness). Freestyle optium blood glucose and freestyle optium beta ketone can be used with the Libre 2 reader or patients can be supplied and trained on an alternative meter for this purpose. FreeStyle Libre 2 and 2 Plus should only be initiated under the advice and ongoing supervision of the specialist diabetes team in line with Scottish Diabetes Group guidance.
• Patients will only be provided with 26 FreeStyle Libre 2 sensors for a year’s supply. If they require any further sensors due to failure of the device then they must contact the company directly and report to the MHRA via the Yellow card scheme.
• Patients will only be provided with 25 FreeStyle Libre 2 Plus sensors for a year's supply. If they require any further sensors due to failure of the device then they must contact the company directly and report to the MHRA via the Yellow card scheme.
• Freestyle Libre 2 Plus is compatible with Omnipod 5 Automated Insulin Delivery System.

Dexcom One+

• Dexcom one+ is a continuous real time glucose monitoring system which monitors interstitial fluid glucose levels via a sensor.
• All individuals on Dexcom one+ will require the facility to use finger prick blood glucose and ketone testing on occasion (e.g. during periods of intercurrent illness). Patients can be supplied and trained on an alternative meter for this purpose. Dexcom one+ should only be initiated under the advice and ongoing supervision of the specialist diabetes team in line with the same criteria as Scottish Diabetes Group guidance for flash glucose monitoring. Dexcom one+ is reserved as second line for patients who have experienced difficulties with Freestyle Libre 2 (e.g. adhesive issues, problems with accuracy or alarms).
• Patients will only be provided with 36-37 Dexcom One+ Sensors for a year’s supply. If they require any further sensors due to failure of the device, then they must contact the company directly and report to the MHRA via the Yellow card scheme.

Prescribing Notes:

• The paediatric diabetes team will provide blood glucose meters to patients with type 1 diabetes.
• People with diabetes treated with insulin must be guided by their diabetes healthcare professional when choosing a suitable blood glucose meter. Many meters now assist with carbohydrate counting, blood glucose pattern management and blood ketone testing and the first-choice meter may not meet the requirements of this patient group.
• Correct meter care and quality control are essential when meters are used.
• Meters are obtainable from diabetes clinics with expert advice from a suitably trained person.
• Strips deteriorate rapidly if exposed to the atmosphere.
• Some people with diabetes may require a specialist meter taking in individual factors and following assessment by specialist diabetes team. It is the responsibility of the specialist team to document and highlight these requests to the referring primary care team. The appropriate testing strips to be prescribed will be detailed in individual patient correspondence.

Prescribing Notes:

• The paediatric diabetes team will provide blood glucose meters to patients with type 2 diabetes.
• Some patients may require a specialist meter taking into account individual factors following assessment by the paediatric diabetes team. The appropriate testing strips to be prescribed will be detailed in individual patient correspondence.
• The specialist paediatric diabetes team recommends home blood glucose monitoring in all children and young people with type 2 diabetes in order to reduce the risk of long-term complications by achieving a target HbA1c of less than 48mmol/mol. The timing of samples will be tailored to the individual patient and education will be provided by the paediatric diabetes team.
• People with diabetes must be aware of how to interpret the results and what action to take on the results obtained. Education is an essential component of self-monitoring of blood glucose.
• Ensure that an assessment is carried out at least annually.
• People with diabetes treated with insulin must be guided by their diabetes healthcare professional when choosing a suitable blood glucose meter. Many meters now assist with carbohydrate counting, blood glucose pattern management and blood ketone testing and the first choice meter may not meet the requirements of this patient group.
• Correct meter care and quality control are essential when meters are used.
• Meters are obtainable from diabetes clinics with expert advice from a suitably trained person.
• Strips deteriorate rapidly if exposed to the atmosphere.
• Some people with diabetes may require a specialist meter taking in individual factors and following assessment by specialist diabetes team. It is the responsibility of the specialist team to document and highlight these requests to the referring primary care team.

Prescribing Notes:

• Correct meter care and quality control are essential when meters are used.
• Meters are obtainable from diabetes clinics with expert advice from a suitably trained person.
• Strips deteriorate rapidly if exposed to the atmosphere.
• Some patients may require a specialist meter taking in individual factors and following assessment by specialist diabetes team. It is the responsibility of the specialist team to document and highlight these requests to the referring primary care team.

Prescribing Notes:

• Please note that the Accu-Chek Performa meter has been discontinued, however the testing strips continue to be available.

Prescribing Notes:

• It is important to test for blood ketones where there is significant risk of diabetic ketoacidosis (DKA), such as people with type 1 diabetes with intercurrent illness, during pregnancy and when using insulin pump therapy.
• People with diabetes, and where appropriate, their carers must be aware of when to test and how to interpret the results including when to seek medical attention.
• FreeStyle Libre 2 has a built-in meter that supports testing of blood ketones using FreeStyleOptium β Ketone Test Strips.
• Blood ketone testing is the most accurate form of testing and should only be undertaken on specialist advice.
• Self-monitoring of blood ketones is not recommended when patients are prescribed an SGLT-2 inhibitor. However, GP surgeries and acute settings can still carry out this monitoring if required.