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.”

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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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Now closed: Any CGM or FreeStyle Libre users in Sweden

Please help us find 50 people in Sweden to take part in market research.

Participants must be using either FreeStyle Libre or any CGM. They will be rewarded with a £15 Amazon.co.uk voucher for screening in and completing the 8 minute questionnaire.

As always, INPUT will also receive a reward for helping to find participants.

To take part, click here: sorry, no more participants are needed

 

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MHRA Medical Device Alert: All Accu-Chek® Insight insulin pumps – updated information for battery management

2 May 2017

Manufactured by Roche Diabetes Care – Replacement and update to MDA/2015/029 with new instructions to improve battery lifetime and prevent unexpected pump shut down or rapid battery depletion. – click on this headline to see the full notice.

Action

  • Identify all users of Accu-Chek Insight insulin pumps.
  • Ensure that all patients and carers:
    • Receive the manufacturer’s Field Safety Notice (FSN)
    • understand the problem detailed in the FSN and follow the advice given by the manufacturer
    • use Energizer® Ultimate lithium batteries (1.5V AAA / FR03) provided by the manufacturer and follow the steps described in the handling instructions in the FSN
  • Contact Roche if you experience unexpected pump shut down or rapid battery depletion.
  • Return the FSN acknowledgment form to Roche as currently the manufacturer hasn’t received enough responses.

 

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Now closed: T1 Adults on MDI, or Medtronic / OmniPod pumps

We have been asked to help find a few people for market research.

They are looking for:

  • 14 adults (over 18) with Type 1 diabetes currently on a multiple daily injections (3 or more per day)
  • 5 adults (over 18) with Type 1 currently using a Medtronic MiniMed pump
  • 7 adults (over 18) with Type 1 currently using an OmniPod

The interviews will take place on 21st. 22nd and 23rd March in London. They will last 60 minutes and you will be paid £65 as an incentive.

To participate: sorry, no more participants are needed

As always, INPUT will also earn a fee for putting you in touch so please mention INPUT when you email.

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Now closed: FreeStyle Libre user survey in UK, Germany, France & Sweden

We have been asked to find Libre users in the UK, France, Germany and Sweden to complete a survey. Adults and parents of under 18’s can all take part.

The survey will take around 20 minutes, and you will receive a £15 Amazon voucher for completing it. You will need to provide your email address at the end of the survey in order to receive your voucher.

We are looking for big numbers:

  • 110 UK participants
  • 110 participants in Germany
  • 110 participants in France
  • 50 participants in Sweden

As always, INPUT will also receive a donation for each participant recruited through our social media channels. These ‘finders fees’ help us to keep running, so we are very grateful to anyone who takes part.

To see if you are eligible and take the survey click on the following links:

 

*** Survey closed ***

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DIaMonD study suggests CGM helps those on MDI

Two randomised controlled trials, recently published in the Journal of American Medicine Association (JAMA), suggest that Controlled Glucose Monitoring (CGM) greatly benefits people with type 1 diabetes (T1) who use multiple daily insulin injections (MDI), and not only the minority using insulin pumps.

The DIaMonD (Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes)  and GOLD studies, the first to focus solely on the benefits of CGM for adult T1s who use MDIs, were commissioned by Dexcom, and conducted in the US and Sweden respectively.

While CGM is currently used mostly by T1 patients using an insulin pump, the study results prove the system to be both beneficial and user-friendly to those on MDIs. A minority of T1 patients use an insulin pump in the UK.

Results of both trials show that Dexcom’s CGM improves HbA1c levels more than conventional treatment; the device can be used directly for making diabetes treatment decisions instead of alerting patients to use a blood glucose monitor to determine treatment.

Study findings also reveal that CGM also helps detect hypoglycaemic episodes, resulting in fewer such attacks and their inherent risks.

The Dexcom CGM system was the first produced worldwide to interact with mobile phones, and may be used with both Android and iOS smartphones, with the need for only two finger stick checks daily.

The system is available in the UK to both T1 patients and those with Type 2 diabetes who are insulin dependent.

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Now closed: 6 pump users aged 18+ for market research focus group

INPUT has been contacted by a market research company organising a half-day long focus group of adult (age 18+) insulin pump users. This small focus group will take place in Central London (exact location to be arranged).

Specifically, they want to speak with:

  • Two long-term (10 years+) pump users who have switched makes of pump (this means from one company to another, rather than different pumps from the same company)
  •  Two newish pump users who got their pump in the past 2 years
  •  One OmniPod user who has switched from another make of pump to their current OmniPod

The event will take place from 12-5pm, with lunch provided, on one of the following dates, depending on what’s best for the participants: Tuesday 28th Feb, or Saturday 4th March.

The incentive? Your travel expenses (up to a maximum £50) will be reimbursed, lunch will be provided, and you’ll get to spend the afternoon with a group of other pump users. Crucially, INPUT will receive a donation of up to £1,350 for finding participants. We are very grateful to those who chose to donate an afternoon of their time to help this project and therefore trigger a huge donation to INPUT.

Thank you for your interest – all spaces have now been filled.

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