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Research shows the benefits of the FreeStyle Libre for people with Type 1 and insulin-treated Type 2 diabetes
The case for the FreeStyle Libre in Type 1 and Type 2 diabetes
Research is building up to support the use of the FreeStyle Libre in people with Type 1 and Type 2 diabetes on multiple doses of insulin. This should surely add weight to the case for widening the already narrow criteria for people to be able to access the device free on the NHS.
The FreeStyle Libre improves control in people with Type 1 diabetes during the first 6 months
An audit of 1,299 people with Type 1 diabetes from the Association of British Clinical Diabetologists (ABCD) compared the 12 months prior to starting the FreeStyle Libre and the result of using it for 6 months.
The results showed important benefits for those using the Libre in terms of lowering glucose levels in people with high levels before using the device and a reduction in the number of hypos. Below are the key results:
There was a significant improvement in diabetes control especially in people who had higher glucose levels before using the FreeStyle Libre.
- 79% reported that with the Libre they reduced their time spent in hypoglycaemia,
- 31% were able to reduce the rate/frequency of hypoglycaemia,
- 39% reduce night time hypos,
- 9% of people reported that they had reversed their hypo awareness.
Hospital admissions were reduced for:
- Diabetic ketoacidosis (DKA)
There was a considerable improvement in diabetes-related emotional distress.
The researchers concluded that the results for the use of 12 months are needed to clearly demonstrate the improvements that can be made. (Presented at the American Diabetes Association’s 79th Scientific Session, June 2019.)
Comment: The evidence is building that this is life-saving technology which improves both quality of life and diabetes control, so reducing the risks of future long-term complications.
FreeStyle Libre in people with Type 2 diabetes using insulin
In a recent study, 101 people with Type 2 diabetes on multiple daily insulin injections for at least a year were randomly assigned to treatment with the FreeStyle Libre or standard care. They were followed for 10 weeks and instructed on adjusting their insulin doses either face-
to-face or by telephone.
The people using the FreeStyle Libre system found:
- Treatment was significantly more flexible and they would recommend it to other people.
- Satisfaction with the system was high.
- The changes in HbA1cs were 9mmol/mol (0.82%) versus 3.6mmol/mol (0.33%) in in the Libre group and the standard care group.
- 68% of the Libre group had their HbA1c reduced by 5.5mmol/mol (0.5%) compared to 30.2% in the standard treatment group.
The researchers concluded that the FreeStyle Libre (flash glucose monitoring) tends to improve treatment satisfactions and can improve glycaemic control in people with Type 2 diabetes and multiple daily injections without increasing the frequency of hypoglycaemia. (Diabetes Care, April 2019)
Abbott reveals more evidence of the benefits of the FreeStyle Libre system
Abbott research has shown that its FreeStyle Libre glucose monitoring system significantly reduces HbA1c levels in certain adults with Type 2 diabetes using multiple daily insulin injections.
Researchers evaluated records of 363 people in this category in France, Germany and Austria assessed their HbA1c levels over 3 to 6 months. The people averaged about 63 years in age and had used insulin multiple times a day for an average of more than 8 years.
The results showed:
- An association of lower HbA1c levels with the use of the Libre after at least three months of use. There was a nearly 1% drop (0.9% or 9.7 mmol/mol) in HbA1c levels.
- The average HbA1c was 8.9% (73.3 mmol/mol) before FreeStyle Libre system use and 8.0% (63.6 mmol/mol) after.
- Researchers detected no differences based on age group, gender, body mass index or duration of insulin use. According to Abbott, this indicates the findings apply to the broad population of people with Type 2 diabetes and not just a particular subset.
One of the lead researchers said, “By using the real-time results, trends and patterns from the technology right at their fingertips, people with diabetes are becoming more actively engaged in making better decisions to control their glucose levels and improve their own health.”
In February, Abbott presented real-world data showing that use of its FreeStyle Libre reduced prolonged hypoglycaemia and helped users achieve better glucose control.
There are over half a million users globally and it is increasingly obvious that use of FreeStyle Libre is associated with improved glucose control and better health outcomes.
Abbott is seeking FDA approval for its next-generation FreeStyle Libre system, which features optional alarms that users can customise. (American Diabetes Association Annual Conference, 8th June 2019)
FreeStyle Libre online education programme launched (April 2019)
A series of free online modules and workshops designed to ensure people get the most out of the FreeStyle Libre are taking place, the webcasts on Monday, April 1, 7pm to 8.40pm and Wednesday, May 15, 6.30pm to 8.30pm. Once the webcasts dates have passed these modules will be available free to watch on the DTN-UK website: https://abcd.care/node/778 These are aimed at both healthcare professionals and people with diabetes, they are being delivered by the Diabetes Technology Network UK (DTN-UK) as part of its FreeStyle Libre Education Programme.
DTN-UK, linked to the Association of British Diabetologists (ABCD), is an organisation which supports healthcare professionals involved in the delivery of technologies designed to improve the lives of people living with diabetes.
The modules lead will present the content followed by an interactive online panel discussion.
- Introduction – Dr Emma Wilmot, Derby
- Mike’s experience of FreeStyle Libre – Mike Kendall, DTN-UK representative
- Getting started with FreeStyle Libre – Dr Peter Hammond, Harrogate
- Interpreting daily traces – Geraldine Gallen, DSN, London
- Basal insulin – Dr Emma Wilmot, Derby
- with insulin pens
- with insulin pumps (online only)
- Carbohydrates – Nicola Taylor, Dietitian, Derby
- Advanced (online only)
- Bolus insulin – Dr Jackie Elliott, Sheffield
- with insulin pens
- with insulin pumps (online only)
- Reviewing my data: what does it all mean? – Dr Fraser Gibb, Edinburgh
- The diabetes rollercoaster – Dr Emma Wilmot and Nick Rycroft, Derby
- Exercise strategies – Dr Parth Narendran, Birmingham and Dr Rob Andrews, Exeter
- Hypoglycaemia – Dr Pratik Choudhary, London
- Understanding arrows – Dr Pratik Choudhary, London
- Glycaemic Variability – Dr Iain Cranston, Portsmouth
Abbott Diabetes Care provided ABCD DTN-UK with a restricted educational grant for the development of these resources.
Freestyle Libra – criteria for availability from April 2019
Updated March 18th 2019
After the announcement from NHS England last November that the FreeStyle Libre would be free on the NHS to people with Type 1 diabetes who fitted into the criteria (not listed at the time), we promised that we would keep our members and others informed of any developments. On March 7th, NHS England published a document containing the criteria for people with Type 1 diabetes to obtain the Libre free on an NHS prescription.
There are parts of this that IDDT finds difficulty understanding the logic, the thinking or the fairness. For instance, it does not mention children or adolescents with Type 1 diabetes, a group who really need this device both for comfort and to encourage them to test more. Equally, it does not mention other conditions along with Type 1 diabetes which we know makes diabetes control more difficult. However, we will take these points up with NHS England at a later date when we know the effects of this on people with Type 1 diabetes but we wanted you to have the necessary information as soon as possible.
- One of the criteria is that you “require intensive monitoring more than 8 times daily, as demonstrated on a meter download/review over the past 3 months”. This means that you have to show that you have done at least 8 tests a day for the last 3 months. This may prove difficult for people who have not been able to obtain this many test strips from their GP!
- The document also states the funding arrangements for Clinical Commissioning Groups (CCGs) giving the maximum amounts that CCGs will be reimbursed for the ongoing costs of the sensors. In 2019/20 CCGs will be reimbursed for each set of sensors prescribed for up to 20% of their Type 1 diabetes population. It contains a list of all CCGs in England, the total number of patients with Type 1 diabetes in each CCG and 20% of this number, so it appears that while there will no longer be a postcode lottery of availability but a financial one on the part of NHS England. Only up to 20% of people with Type 1 in each CCG will have access to the Libre so for instance, in Darlington CCG the 20% figure is 112 patients with Type 1 diabetes, so what happens if you are patient number 113 but still fit into the criteria for the Libre on the NHS?
- For people who are already using the Libre and obtaining sensors on the NHS but do not fit into the new criteria, then CCGs should consider providing it if people fall into existing local CCG criteria and there have been observable improvements in their glucose management or psycho-social wellbeing (such as depression, stress or anxiety levels).
- The Libre on the NHS can be obtained from either the hospital clinic (secondary care) or from your GP practice (primary care) depending on where you receive your treatment.
If you do obtain a Libre, it is only available initially for 6 months and future supply is dependent on demonstration of improvements in diabetes self-management, such as an improved HbA1c, time in target glucose range, improvements in DKA or hypoglycaemia or psycho-social wellbeing.
We would recommend that you keep records, certainly, your glucose test results and your HbA1cs, details of hypos and/or DKA and anything else you feel is important to you. If you do obtain a Libre, it is only available initially for 6 months and future supply is dependent on demonstration of improvements in diabetes self-management, such as an improved HbA1c, time in target glucose range, improvements in DKA or hypoglycaemia or psycho-social wellbeing.
If you are already using the FreeStyle Libre and paying privately, then it is important that you keep records of any improvements you have experienced while using it if you want to try to obtain it free on the NHS.
If you apply to obtain the FreeStyle Libre on the NHS, please do let us know what happens to you by writing to me at the above address, email me on email@example.com or give us a call on 01604 622837.
Flash Glucose Monitoring: National Arrangements for Funding of Relevant Diabetes Patients (PDF) – from NHS England
FreeStyle Libre available on the NHS from April 2019, but…
To coincide with World Diabetes Day, Simon Stevens, Chief Executive of NHS England, announced action to end the postcode lottery for access to the FreeStyle Libre flash glucose monitoring system. A press release was issued:
“From April 2019, the device will be available on prescription for all patients who qualify for it in line with NHS clinical guidelines. These patients will be able to receive it on prescription from their local GP or diabetes team helping them to better manage their blood sugar levels.
The device should ultimately help people with Type 1 diabetes to achieve better health outcomes and benefits including:
- Easily noticing when their sugar levels are starting to rise or drop, so action can be taken earlier,
- Giving patients more confidence in managing their own condition, Not having to do as many finger-prick checks.
The funding for this will come from next year’s funding growth for local health groups which will allow flash monitoring throughout the country.”
The Press release also says:
“It is estimated that around 3-5% of patients with Type 1 diabetes in England have access to Freestyle Libre but if clinical commissioning groups (CCGs) were following the guidance correctly, this figure could eventually rise to at least 20-25%. Currently, 144 of 195 clinical commissioning groups have signed up, and today’s announcement mean thousands of patients still missing out will now get access.”
The news was very much welcomed by people with Type 1 diabetes across the country and it was good to know that apparently people with diabetes have been heard. It appears to end the unfairness that has existed whereby there has been a postcode lottery of availability of the Libre but there were various points that are still unclear and left unanswered questions.
On November 21st 2018, IDDT wrote to Simon Stevens with copies to Dr Partha Kar, Associate National Clinical Director for Diabetes, Mr Matt Hancock, Secretary of State for Health and Social Security and Mr Keith Vaz MP. The points we have made are:
- The announcement only mentions people with Type 1 diabetes and not people with Type 2 diabetes who are injecting insulin but the NICE guidance for the approval of the FreeStyle Libre states that “it is an alternative to routine blood glucose monitoring in people with Type 1 and Type 2 diabetes who use insulin injections”. Why has this group been excluded from the benefits of the FreeStyle Libre? This seems grossly unfair and is a divisive decision.
- People who have been refused access to the FreeStyle Libre by the CCG in their local area, have been told that CCGs make decisions according to local need. While appreciating that this device will be funded from next year’s funding growth for local groups, how can CCGs be effectively forced to fund the FreeStyle Libre when the NHS system specifically gives them control over local spending according to local need? Are people with diabetes going to have to go through the process of refusal again?
- The press release states that the FreeStyle Libre will be available “for all patients who qualify for it in line with NHS Clinical guidelines”. We are aware that the Guidelines that have been used have varied geographically, could we be told what these guidelines are, especially now that there is a second version of the FreeStyle Libre with an alarm system?
IDDT has still not received any response to our letter of November 21st 2018.
NHS Long Term Plan
In January 2019 the NHS 10-year Plan was announced and one of the paragraphs under the title of ‘Diabetes’ promised:
“People with Type 1 diabetes will benefit from flash glucose monitors from April 2019 in line with clinical guidelines to end the variation of availability across the country.”
We will have to see how this works in practice…