Access to Flash Glucose Monitoring (Flash GM)

Diabetes UK, INPUT and JDRF believe that Flash GM devices should be made available to any adult or child with type 1 diabetes, and to people with other forms of diabetes when intensive insulin therapy becomes necessary as outlined in our guideline.

Following campaigning across the diabetes community, from 1st November 2017 Flash GM will be made available on the NHS Drugs Tariff. This means in principle it is available to people with diabetes on NHS prescription.

It will now be up to local decision makers to draw-up policies about who can access the technology and in what ways.

Guidance on these local policies will come from specialists within the NHS and the final decisions on access will be made by local health decision makers.

Diabetes UK, INPUT and JDRF will work together to:

  • Ensure that the voices of people with diabetes are heard, and that their needs are forefront in decision-making.
  • Seek solutions to address barriers to access locally and nationally as they occur.
  • Inform people with diabetes about access and support people to know their rights.

We will continue to work together until those who would benefit and like to use Flash GM can easily and simply access it on the NHS.

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Market research: T1D insulin pump users, Manchester

Market research opportunity:
Pump users – £80 incentive for 75 minute interview in Manchester

When our posts help to recruit participants for market research we earn a finder’s fee. These fees help with our running costs. By taking part or sharing our posts, you are helping to raise vital income for INPUT. Thank you!

 

Acumen Healthcare are looking to speak with people who have been diagnosed with type 1 diabetes who currently use an insulin pump, to take part in a 75 minute research session.

For taking part in this research you would receive £80 as a thank you. Sessions are between Monday 13th November and Thursday 16th November and they have various times available. The research is taking place in central Manchester (M1).

If you are interested please follow the link below to apply – and mention INPUT!
www.healthcareopinions.co.uk/projects/manchester/diabetes-5/

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New OneTouch Reveal mobile app

Press release by OneTouch on 12 September 2017

New OneTouch Reveal® Mobile App Empowers People with Diabetes to Manage their Blood Sugar and Easily Connects them with their Diabetes Care Support Network

Easy-to-use interconnected diabetes management system changes the way patients see their blood sugar readings and enables healthcare professionals, family, and friends to help them manage their condition

The new OneTouch Reveal® mobile app is now available in the UK and Ireland. It includes innovative, user-inspired features including blood sugar and activity timelines transformed into quick visual snapshots which allow people with diabetes to see their results, identify trends and get on with their daily life.

The new version of the OneTouch Reveal® mobile app has been designed to help patient engagement. It has an easy to use interface that changes the way patients see their blood sugar and manage their diabetes. In addition to the timeline and visual logbook, new features include a fingerprint login, an events newsfeed featuring relevant articles, a reminder function, averages for 14-, 30-, or 90- day time periods, and a break out of pre- and post-meal tagged results. The OneTouch Reveal® mobile app also uses ColorSure™ technology, which highlights patterns that show users a bigger picture.

 

Dr Iain Cranston, Consultant Physician at Portsmouth Hospitals NHS Trust said, “It is important that people with diabetes who test their blood sugar levels regularly are able to utilise the information from such tests to adjust therapies which may help with better overall control. Modern meters and apps (such as OneTouch Reveal®) which allow patients to easily assess patterns are thus an important part of this progressive process of improvement.”

 

The OneTouch Reveal® mobile app is the central component of the OneTouch® circle of support that connects patients to resources beyond devices. The OneTouch Reveal® mobile app seamlessly syncs with the OneTouch Verio Flex® blood glucose monitoring (BGM) system with built-in Bluetooth® Smart Technology. This connectivity enables users to see their blood glucose readings on the mobile app on their smart device and on their computer through the OneTouch Reveal® web app, and also makes it easier than ever for patients to share their data with their healthcare teams so that the teams can see their progress.

 

Chris Aldred, aka The Grumpy Pumper has been trying out the OneTouch Reveal® mobile app. He said “I’m not one for logging my data or messing about with cables for uploading it, I’ve got a life to live and it’s not going to be slowed down by my Diabetes. So at the times I do want to log my data, such as annual review time, being able to Bluetooth it across to the app is really useful.”

Martin Lambert, Head of Marketing UK&I, Johnson and Johnson Diabetes Care Companies (makers of OneTouch® products) said “We are delighted to launch the new OneTouch Reveal® mobile app and digital platform. We have designed the new interface with engaging social networking apps in mind, to appeal both to people with diabetes who are new to digital diabetes apps, as well as those who are more familiar with their use. Enhanced connectivity and the new user experience to help people with diabetes to quickly see and check their results, allowing them to make meaningful decisions and take an active role in their diabetes management.”

With more than 312,000 total downloads and 34 million plus blood glucose readings, the OneTouch Reveal® mobile app is one of the top downloaded diabetes apps globally.[1] In a clinical study, eight out of 10 people who had used the OneTouch Reveal® mobile app agreed that it helped them to better manage their blood glucose.[2]

About Johnson & Johnson Diabetes Care Companies (JJDCC)

With a shared vision of creating a world without limits for people with diabetes, the Johnson & Johnson Diabetes Care Companies are a collaboration of Johnson & Johnson companies dedicated to diabetes and includes LifeScan, Inc., a world leader in blood glucose monitoring; Animas Corporation, maker of innovative insulin delivery systems; Calibra Medical, Inc. developer of OneTouch Via™ on-demand insulin delivery; and the Johnson & Johnson Diabetes Institute, LLC, a global initiative to improve care and better outcomes worldwide through education and training programs. In the U.S., LifeScan, Inc. is the leading blood glucose monitoring company and OneTouch® brand products are recommended by more endocrinologists and primary care physicians than any other brand.[3] Globally, more than 20 million people depend on OneTouch® brand products to help them manage their diabetes. For more information, visit: www.myOneTouch.co.uk

 

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Patient representatives needed for Kent, Sussex & Surrey Diabetes Technology Collaborative

INPUT is delighted to be part of a type 1 diabetes adult service improvement project in Kent, Sussex & Surrey. Aimed at improving access to technology and reducing variation in access across the region, this 2 year project will be launched in October 2017.

The project is looking for 10 patient representatives (adult clinics) from across the region, who use insulin pumps or CGM and have experience of receiving care with their local team. If you transferred to a London clinic in order to access pump therapy you would also be welcome as long as you still live in the KSS area.

It is hoped that patient representatives will be joined up with their local Trust team during the 4 quality improvement workshop events where the Trust teams would be reviewing why in their service patients are experiencing difficulty in accessing medical technology and how access can be improved.

Patient representatives will need to commit to attend all 4 workshop days, to be held in the KSS region, and the workshops will run from around 9am to 4:30pm.

The workshop event days are

Workshop 1, Wednesday, 18 October 2017

Workshop 2, 28th February 2018

Workshop 3, 13th June 2018

Workshop 4, 19th September 2018

If you would like to be considered, please email
kssahsn.diabetes@nhs.net

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MHRA Medical Device Alert: All Accu-Chek® Insight insulin pumps – risk of alarm failure

20 September 2017

Roche Accu-Chek Insight insulin pumps – the audible and/or vibration alarms might not function, which may lead to hyperglycaemia if the user doesn’t see the notification message on the pump.

All patients and carers using the Accu-Chek Insight insulin pump will receive the manufacturer’s Field Safety Notice (FSN).

Pump users should check the display of the insulin pump regularly and:

  • seek clinical advice if they are concerned and have an alternative insulin therapy available if necessary
  • contact Roche Careline to get a replacement if the pump continues to display the ‘E7’ error message
  • return the FSN acknowledgment form (sent by Roche to all Insight users) to Roche as currently the manufacturer has not received sufficient responses

Problem / background

Due to an electrical issue there is a risk of a vibrator alarm failure and an intermittent audible alarm failure.

The alarm failures will be detected during a pump’s self-test, which is prompted by changing the battery or insulin cartridge. If the failures are detected, the E7 error shows on the pump’s display.

Users should contact the customer careline as instructed in the user manual if they cannot resolve an E7 error message.

Manufacturer contacts
Roche Diabetes Care
Tel: 0800 731 2291

burgesshill.insulinpumps@roche.com

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MHRA Field Safety Notice: Medtronic Infusion sets (specific lot numbers)

September 2017

Medtronic MiniMed Infusion Sets – Recall of Specific Lot Numbers –
Potential over-delivery of insulin

Medtronic voluntarily recalled specific lots earlier this month. Every Medtronic pump users should have been contacted by now.

The specific lot numbers are:

Medtronic MiniMed Quick-set (MMT-394, 384, 399, 387, 398, 397, 386, 396)

Medtronic MiniMed Silhouette (MMT-377, 378, 384, 368, 381, 382, 383)

Medtronic MiniMed Sure-T (MMT-862, 862T, 864, 866, 874, 876, 884, 886)

Medtronic MiniMed Mio (MMT-921, 923, 925, 941, 943, 945, 961, 963, 965, 975)

Medtronic MiniMed Mio 30 (MMT-905, 906)

Patients are asked to go to www.mmc.medtronic-diabetes.com/look and determine if they are using recalled infusions sets. The website will prompt them to enter the REF and LOT numbers for all infusion sets in their possession. The website will tell them which infusion sets are part of this recall and which are not.

Patients are asked not to use any recalled infusion sets, but to discard them. Medtronic will replace the recalled infusion sets free of charge.

Click here to see the full Notice.

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REPOSE study – its value and impact

You may have seen the social media storm that unfolded when the REPOSE study was published in March 2017. With this article we hope to give all relevant information and perhaps calm some fears.

Link to research article in BMJ

For many years some have been asking

  1. should insulin pumps be available to everyone on insulin including those who don’t meet the criteria set out in NICE TA151? and
  2. do pump users tend to get better outcomes than those on multiple daily injections (MDI)  because of the pump or because of the extra education given to them?

REPOSE was designed to answer those questions.

The 2-year study involved 248 participants at its conclusion.

Participants had to meet all the following inclusion criteria:

  • adults with type 1 diabetes for at least 12 months
  • willing to undertake intensive insulin treatment with self monitoring of blood glucose levels, carbohydrate counting and insulin adjustment
  • no preference for either pump or multiple daily injections
  • with clinical indications for structured education in insulin treatment to optimise diabetes control who had not participated previously in structured training

The following were excluded from taking part:

  • those who meet the NICE criteria for pump treatment
  • those needing a pump in the opinion of the investigator
  • those with a strong desire for pump treatment
  • those with serious diabetic complications
  • and those unable to communicate in English

Study intervention

Participants were randomised to the MDI or pump treatment group.

MDI group:

  • attended standard DAFNE structured education course over five consecutive days in groups of 5-8 adults as outpatients
  • they took Humalog or NovoRapid for meals and twice daily injections of Levemir
  • they used the Accu-Chek Aviva Expert Bolus Advisor System as a bolus calculator

Pump group:

  • attended a modified DAFNE course, previously validated in pump users, over five consecutive days. The course also incorporated the practical skills and learning outcomes needed to use pumps successfully delivered in an additional group session, one to three weeks before the main course.
  • used a Minimed Paradigm Veo insulin pump with Humalog or NovoRapid
  • the bolus wizard in the pumps was activated as part of the course

Outcomes

The study measured:

  1. change in HbA1c if it was 7.5% / 58mmols/mol or over at the start of the study;
  2. proportion of participants reaching NICE 2004 target HbA1c equal to or less than 7.5% / 58mmols/mol;
  3. episodes of moderate or severe hypoglycaemia;
  4. cholesterol levels; proteinuria; insulin dose; body weight.

Diabetic ketoacidosis was recorded through the assessment of serious adverse events throughout the trial.

It also looked at psychosocial outcomes including satisfaction with treatment, diabetes related quality of life, fear of hypoglycaemia and emotional wellbeing.

Primary outcomes

HbA1c: the pump group did slightly better but the difference between the groups was not clinically significant.

Proportion of participants reaching HbA1c ≤7.5% (58 mmol/mol): the pump group did slightly better (25.0% vs 23.3% of the MDI group).

Secondary outcomes

Severe hypoglycaemia: no difference in rates of severe hypoglycaemia between the treatment groups. Across both treatment groups, the number of severe hypoglycaemic episodes was reduced.

Moderate hypoglycaemia: by 24 months, the MDI group did slightly better but there was no statistically significant difference between the groups.

Other biomedical outcomes

No statistically significant difference between the treatment groups at any time point.

Diabetic ketoacidosis

The number or type of serious adverse events did not differ between the groups, with the exception of diabetic ketoacidosis, which was greater in the pump group compared with MDI group (17 v 5). In the first year, more patients using pumps than using MDI had several episodes (5 v 2). Most episodes of ketoacidosis were caused by infections and 18% by set failure in those using pumps. Only five episodes occurred when participants implemented all sick day rules.

Ancillary outcomes

No differences between the  groups were found in the generic quality of life and health status instruments.

The overall diabetes specific quality of life showed that both groups improved, more in the pump group than the MDI group, although not always reaching statistical significance.

Regarding diet restrictions and daily hassle, the pump group had better outcomes.

The pump group also had better improvement in treatment satisfaction at all time points but the difference was statistically significant at 12 and 24 months only.

The authors concluded:”People with type 1 diabetes might be better served by ensuring far greater availability of high quality, structured self management training, which is currently only accessed by around 10% of adults in the UK. Participants might only recognise the limitations of insulin delivery by MDI if they start actively managing their diabetes after training. Those individuals could then be offered pump treatment to help them reach the stringent glucose targets necessary to achieve an HbA1c of 6.5% or to overcome problematic hypoglycaemia.”

———-

Following some initial criticism to the BMJ article, the study authors response included the following:

“… our study by design meant we should exclude patients who had expressed a wish to use insulin pumps. … We also … excluded patients who met NICE criteria because the case for pumps (CSII) in that group is not in doubt. We have written to NICE to assure them that the results of REPOSE have no implications for the guidance in TA151. Our aim was to explore whether there was merit in extending indications for insulin pumps to a wider range of patients, including individuals whose HbA1c levels were far from target and who had yet to receive structured education to aid them in undertaking the complex skills of insulin self-management.

We believe that the priority of the diabetes community in the UK should be ensuring that individuals receive more effective structured training and ongoing support, issues we are addressing in ongoing research. In the meantime, as we conclude in our paper, pumps should be offered widely to individuals who are trained to manage their condition but find that the limitations of intermittent injections lead to hypoglycaemia or prevent them achieving tight glucose targets. The ambitious target of 6.5% HbA1c in the latest NICE guideline will increase their number.”

———-

The Association of British Clinical Diabetologists (ABCD) Insulin Pump Network UK has also published a position statement on the results of REPOSE, including the following:

“The results of the REPOSE (Relative Effectiveness of Pumps Over Structured Education) trial were published recently in the BMJ. The ABCD Insulin Pump Network Committee have become aware of a number of cases where the findings have been misreported and/or misinterpreted. We thought it would be helpful for readers of British Journal of Diabetes if we clarify the main REPOSE findings and implications for clinical practice in the UK…

By design, the REPOSE study excluded patients who met the … TA151 criteria for CSII, examining whether CSII should be more widely available in T1D. Importantly, the results of REPOSE are thus not relevant to the patients currently covered by the evidence-based recommendations of TA151 and who would still be considered for CSII. REPOSE provided DAFNE education to both arms, finding sustained improvements in both arms in glycaemic control and measures of quality of life, reinforcing the use of structured education as an effective strategy in T1D.

In summary, the REPOSE findings support the current NICE T1D pathway, with structured education being offered first and CSII therapy then being considered where patients are still struggling to achieve glycaemic goals safely as set out in TA151. Sadly, most patients with T1D in the UK have not been offered evidence-based structured education. Similarly, access to CSII remains patchy, with the level of provision of CSII being lower than in other comparable countries. There is a danger that misrepresentation of the REPOSE data could worsen this inequality.”

Comment from INPUT

Essentially, REPOSE backed up the criteria set by NICE TA151 for pump therapy, ie, structured education first, and then pump therapy if treatment targets are still not met. It is a failure of the system when some patients are only offered structured education in preparation for starting on a pump.

NICE TA151 still stands, along with its mandate that CCGs MUST provide funding for pump therapy if a patient meets the criteria and has the consultant’s agreement that a pump is required.

When NICE TA151 is reviewed at some point in the future, REPOSE will not have a negative impact on access to pumps. It simply shows that “pumps for all” cannot be supported by evidence.

If you believe you meet the NICE criteria for pump therapy and have been denied pump treatment, please contact us.

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Market research: FreeStyle Libre users, London

 

 

Market research opportunity: Freestyle Libre users – £125 incentive for 90 minute focus group in London

 

 

 

When our posts help to recruit participants for market research we earn a finder’s fee. These fees help with our running costs. By taking part or sharing our posts, you are helping to raise vital income for INPUT. Thank you!

Creative Medical Research,  a UK-based market research agency, wants to talk to people who use the Freestyle Libre flash glucose monitor, to understand their experience using the reader and sensor.  The research will involve a 90 minute focus group discussion with other Freestyle Libre users, in Holborn London on 27 July in the late afternoon/evening.

In order to take part, you must meet all the following qualifiers:

  • be aged over 18
  • have Type 1 diabetes
  • be on injections (not a pump)
  • and using the Libre for at least 3 months

You will receive a cash incentive of £125 for taking part and as usual INPUT will receive a finder’s fee for all participants who quote our name when contacting the agency.

For more information and to run through some screening questions, please contact Matt.Bowles@creativemedicalresearch.com and say INPUT sent you!

 

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£50 for 45 minute interview: Leeds/London, aged 12-22 or parents

When our posts help to recruit participants for market research we earn a finder’s fee. These fees help with our running costs. By taking part or sharing our posts, you are helping to raise vital income for INPUT. Thank you!

Acumen Fieldwork are looking for the following participants:

  • adolescents (aged 12 – 22) with type 1 or type 2 diabetes
  • parents of children with type 1 or type 2 diabetes

to give feedback on  the design of a new blood glucose device, in these 2 locations:

Leeds (LS1) –  Friday 19th May

London (WC2) – Monday 22nd, Tuesday 23rd , Wednesday 24th May

Interviews are one to one and will last for 45 minutes, participants will be paid £50 as a thank you for their time

Participants will be asked to give feedback on a new blood glucose device and will be asked to demonstrate using a blood glucose meter with simulation blood (no finger pricking is involved)

 

Anyone who is interested in taking part can call Vicki Moran on 0161 242 5215 or email her on vicki.moran@acumenfieldwork.com for more information. Vicki will run though a few screening questions before confirming anyone on to the research.

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Market research: CGM users or Accu-Chek Mobile users, various locations

When our posts help to recruit participants for market research we earn a finder’s fee. These fees help with our running costs. By taking part or sharing our posts, you are helping to raise vital income for INPUT. Thank you!

Acumen Fieldwork are looking for participants in various locations.

Anyone who is interested in taking part can call Vicki Moran on 0161 242 5215 or email her on vicki.moran@acumenfieldwork.com for more information. Vicki will run though a few screening questions before confirming anyone on to the research.

ACCU-CHEK MOBILE USERS

London (WC2): Monday 22nd , Tuesday 23rd  or Wednesday 24th May  (various times available)

Leeds (Wednesday 17th May – Friday 19th May)

and Manchester (Monday 15th – Tuesday 16th May)

Adults and Adolescents  (aged 12+) using Accu-Chek Mobile

Plus Caregivers- providing care for someone who has been diagnosed with Type 1 or Type 2 diabetes using Accu-Chek Mobile such as performing the majority of BG measurements for them (the person they are providing care for will not be required to attend)

Interviews are one to one and will last for 45 minutes, participants will be paid £50 as a thank you for their time

Participants will be asked to give feedback on a new blood glucose device and will be asked to demonstrate using a blood glucose meter with simulation blood (no finger pricking is involved)

CGM USERS

London (EC1V): Thursday 11th May or Friday 12th May (various times available)

Bristol (Monday 15th May, Tuesday 16th May)

and Manchester (Monday 8th May, Tuesday 9th May, Wednesday 10th May)

Adults and Adolescents (aged 12+)  with CGM inserter experience

Interviews and will last 75 minutes, participants will be paid £90 as a thank you for their time

One to one interviews with diabetes patients to inform the design of inserter devices intended to be used as part of a continuous glucose monitoring system. During the session participants will be asked to demonstrate the use of the devices by trialling prototypes on a protective skin belt.

———-

Anyone who is interested in taking part can call Vicki Moran on 0161 242 5215 or email her on vicki.moran@acumenfieldwork.com for more information. Vicki will run though a few screening questions before confirming anyone on to the research.

 

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