NIHR Signal Insulin pumps not much better than multiple injections for intensive control of type 1 diabetes

Published on 11 July 2017

People with type 1 diabetes offered insulin pumps did not achieve better blood glucose control compared with those using multiple daily injections. Education remains important.

While both groups saw improvements in blood glucose levels and fewer hypoglycaemic episodes (very low blood sugar) over two years, only one in four participants met NICE blood glucose targets. Insulin pump users showed some modest improvements in satisfaction, dietary freedom and daily hassle.

All participants in this NIHR trial attended a training course on managing their insulin levels before randomisation. This is important because previously observed benefits from pump treatment might actually have been a reflection of the training given to them.

Currently just 10% of adults with type 1 diabetes access these training courses. These results support NICE guidelines around the restricted use of insulin pumps and suggest that training improves self-management of the condition. Efforts should therefore be made to encourage training uptake.

Insulin pumps not much better than multiple injections for intensive control of type 1 diabetes

Why was this study needed?

People with type 1 diabetes require lifelong treatment with insulin. Doses are adjusted according to food intake, physical activity, and blood glucose level. High or low blood glucose levels lead to serious short and long term complications, however, many people struggle to maintain blood glucose levels within the target range.

Insulin pumps are small devices, about the size of a mobile phone, that deliver a steady flow of insulin. They offer an alternative to multiple daily injections, and may also help people who are unable to achieve blood glucose control. They are expensive though, costing around £2-3,000, with another £1,500 per year in consumables, and have a life span of four to eight years.

About 6% of UK adults with type I diabetes use pumps, which is lower than in many countries. Proponents of pumps suggest more people should be offered them. The aim of this study was to compare the effectiveness of pumps with multiple daily injections.

What did this study do?

The Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE) randomised controlled trial included 317 adults with type 1 diabetes.

All participants were first placed on a one week training course (Dose Adjustment For Normal Eating: DAFNE) that taught them how to adjust their insulin dose based on estimated carbohydrate intake. They were then randomly allocated to insulin pump or multiple daily injections for two years if their HbA1c values were 7.5% (59mmol/mol) or higher after the education. Blood glucose HbA1c (glycated haemoglobin) is a measure of blood glucose control over several months and was assessed “blind” at a central laboratory. About a quarter either did not attend classes or had HbA1c values lower than this threshold and this left 235 people for the analyses (119 pump users and 116 in the injections group).

Patients knew which group they were in, as pumps and injections are fundamentally different. The study was designed to be large enough to detect a minimal clinically important difference of 0.5% (5.5mmol/mol) in HbA1c values, if one existed. It was run in eight specialist NHS centres and the findings are relevant to usual practice.

What did it find?

  • Blood glucose control improved in all participants, with no statistically significant difference between groups. The mean reduction in HbA1c was 0.85% with pump treatment and 0.42% with injections (odds ratio 1.22, 95% confidence interval 0.62 to 2.39). Only one in four participants achieved the NICE 2004 target for HbA1c of 7.5% (58mmol/mol) or less by two years (25.0% for the pump group and 23.3% for the injections group).
  • There was no difference between groups in the number of severe low blood glucose (hypoglycaemic) episodes. The average number of episodes per patient per year reduced from 0.17 at the beginning of the study to 0.10 at the end of the study.
  • More people in the pump group suffered from diabetic ketoacidosis, a potentially life-threatening complication caused by lack of insulin, most often due to infection (17 events compared to five events in the injection group). Nearly one in five episodes of ketoacidosis were said to be due to insulin pump failure.
  • Various generic and diabetes specific quality of life measures showed little difference between groups. Pump users reported higher scores in some domains, for example, treatment satisfaction, improved dietary freedom and reduced daily hassle.

What does current guidance say on this issue?

NICE guidance from 2008 recommends that insulin pumps should only be considered for adults with type 1 diabetes who have tried injections but have found that either their blood sugar levels have remained high (HbA1c of 8.5% [69mmol/mol] or above), or they suffer from anxiety about unpredictable episodes of hypoglycaemia (called “disabling hypoglycaemia”).

Pump therapy should only be continued if it results in a sustained improvement in blood sugar control, evidenced by a fall in HbA1c levels, or a sustained decrease in the rate of hypoglycaemic episodes. Appropriate targets should be set by the physician, in discussion with the patient, but are typically close to 6.5% (48mmol/mol) for those at low risk of hypoglycaemia.

What are the implications?

Although participants in both groups showed sustained improvement, blood glucose control remained far short of targets currently recommended by NICE. Only 3% of all participants reached an HbA1c of 6.5% (48mmol/mol) or less. People with type 1 diabetes might be better served by ensuring greater availability of high quality, structured self-management training, which is currently only accessed by around 10% of adults in the UK.

Simply increasing use of insulin pumps may increase resource costs without seeing improvements to diabetes control. If after training individuals still find blood glucose control challenging, they could be offered pump treatment in line with NICE guidance to see if this improves quality of life.

Citation and Funding

REPOSE Study Group. Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE). BMJ. 2017;356:j1285.

This project was funded by the National Institute for Health Research UK Health Technology Assessment Programme (project number 08/107/01).

Bibliography

NICE. Continuous subcutaneous insulin infusion for the treatment of diabetes mellitus. TA151. London: National Institute for Health and Care Excellence; 2008.

NICE. Type 1 diabetes in adults: diagnosis and management. NG17. London: National Institute for Health and Care Excellence; 2015.

The Healthcare Quality Improvement Partnership (HQIP). National Diabetes Audit 2012-2013 Report 1: care processes and treatment targets. London: Health and Social Care Information Centre; 2014.

Why was this study needed?

People with type 1 diabetes require lifelong treatment with insulin. Doses are adjusted according to food intake, physical activity, and blood glucose level. High or low blood glucose levels lead to serious short and long term complications, however, many people struggle to maintain blood glucose levels within the target range.

Insulin pumps are small devices, about the size of a mobile phone, that deliver a steady flow of insulin. They offer an alternative to multiple daily injections, and may also help people who are unable to achieve blood glucose control. They are expensive though, costing around £2-3,000, with another £1,500 per year in consumables, and have a life span of four to eight years.

About 6% of UK adults with type I diabetes use pumps, which is lower than in many countries. Proponents of pumps suggest more people should be offered them. The aim of this study was to compare the effectiveness of pumps with multiple daily injections.

What did this study do?

The Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE) randomised controlled trial included 317 adults with type 1 diabetes.

All participants were first placed on a one week training course (Dose Adjustment For Normal Eating: DAFNE) that taught them how to adjust their insulin dose based on estimated carbohydrate intake. They were then randomly allocated to insulin pump or multiple daily injections for two years if their HbA1c values were 7.5% (59mmol/mol) or higher after the education. Blood glucose HbA1c (glycated haemoglobin) is a measure of blood glucose control over several months and was assessed “blind” at a central laboratory. About a quarter either did not attend classes or had HbA1c values lower than this threshold and this left 235 people for the analyses (119 pump users and 116 in the injections group).

Patients knew which group they were in, as pumps and injections are fundamentally different. The study was designed to be large enough to detect a minimal clinically important difference of 0.5% (5.5mmol/mol) in HbA1c values, if one existed. It was run in eight specialist NHS centres and the findings are relevant to usual practice.

What did it find?

  • Blood glucose control improved in all participants, with no statistically significant difference between groups. The mean reduction in HbA1c was 0.85% with pump treatment and 0.42% with injections (odds ratio 1.22, 95% confidence interval 0.62 to 2.39). Only one in four participants achieved the NICE 2004 target for HbA1c of 7.5% (58mmol/mol) or less by two years (25.0% for the pump group and 23.3% for the injections group).
  • There was no difference between groups in the number of severe low blood glucose (hypoglycaemic) episodes. The average number of episodes per patient per year reduced from 0.17 at the beginning of the study to 0.10 at the end of the study.
  • More people in the pump group suffered from diabetic ketoacidosis, a potentially life-threatening complication caused by lack of insulin, most often due to infection (17 events compared to five events in the injection group). Nearly one in five episodes of ketoacidosis were said to be due to insulin pump failure.
  • Various generic and diabetes specific quality of life measures showed little difference between groups. Pump users reported higher scores in some domains, for example, treatment satisfaction, improved dietary freedom and reduced daily hassle.

What does current guidance say on this issue?

NICE guidance from 2008 recommends that insulin pumps should only be considered for adults with type 1 diabetes who have tried injections but have found that either their blood sugar levels have remained high (HbA1c of 8.5% [69mmol/mol] or above), or they suffer from anxiety about unpredictable episodes of hypoglycaemia (called “disabling hypoglycaemia”).

Pump therapy should only be continued if it results in a sustained improvement in blood sugar control, evidenced by a fall in HbA1c levels, or a sustained decrease in the rate of hypoglycaemic episodes. Appropriate targets should be set by the physician, in discussion with the patient, but are typically close to 6.5% (48mmol/mol) for those at low risk of hypoglycaemia.

What are the implications?

Although participants in both groups showed sustained improvement, blood glucose control remained far short of targets currently recommended by NICE. Only 3% of all participants reached an HbA1c of 6.5% (48mmol/mol) or less. People with type 1 diabetes might be better served by ensuring greater availability of high quality, structured self-management training, which is currently only accessed by around 10% of adults in the UK.

Simply increasing use of insulin pumps may increase resource costs without seeing improvements to diabetes control. If after training individuals still find blood glucose control challenging, they could be offered pump treatment in line with NICE guidance to see if this improves quality of life.

Citation and Funding

REPOSE Study Group. Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE). BMJ. 2017;356:j1285.

This project was funded by the National Institute for Health Research UK Health Technology Assessment Programme (project number 08/107/01).

Bibliography

NICE. Continuous subcutaneous insulin infusion for the treatment of diabetes mellitus. TA151. London: National Institute for Health and Care Excellence; 2008.

NICE. Type 1 diabetes in adults: diagnosis and management. NG17. London: National Institute for Health and Care Excellence; 2015.

The Healthcare Quality Improvement Partnership (HQIP). National Diabetes Audit 2012-2013 Report 1: care processes and treatment targets. London: Health and Social Care Information Centre; 2014.

Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE)

Published on 8 February 2017

Heller, S, The REPOSE Study Group

BMJ , 2017

Objective To compare the effectiveness of insulin pumps with multiple daily injections for adults with type 1 diabetes, with both groups receiving equivalent training in flexible insulin treatment. Design Pragmatic, multicentre, open label, parallel group, cluster randomised controlled trial (Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE) trial). Setting Eight secondary care centres in England and Scotland. Participants Adults with type 1 diabetes who were willing to undertake intensive insulin treatment, with no preference for pumps or multiple daily injections. Participants were allocated a place on established group training courses that taught flexible intensive insulin treatment (“dose adjustment for normal eating,” DAFNE). The course groups (the clusters) were then randomly allocated in pairs to either pump or multiple daily injections. Interventions Participants attended training in flexible insulin treatment (using insulin analogues) structured around the use of pump or injections, followed for two years. Main outcome measures The primary outcomes were a change in glycated haemoglobin (HbA1c) values (%) at two years in participants with baseline HbA1c value of ≥7.5% (58 mmol/mol), and the proportion of participants achieving an HbA1c value of <7.5%. Secondary outcomes included body weight, insulin dose, and episodes of moderate and severe hypoglycaemia. Ancillary outcomes included quality of life and treatment satisfaction. Results 317 participants (46 courses) were randomised (156 pump and 161 injections). 267 attended courses and 260 were included in the intention to treat analysis, of which 235 (119 pump and 116 injection) had baseline HbA1c values of ≥7.5%. Glycaemic control and rates of severe hypoglycaemia improved in both groups. The mean change in HbA1c at two years was −0.85% with pump treatment and −0.42% with multiple daily injections. Adjusting for course, centre, age, sex, and accounting for missing values, the difference was −0.24% (−2.7 mmol/mol) in favour of pump users (95% confidence interval −0.53 to 0.05, P=0.10). Most psychosocial measures showed no difference, but pump users showed greater improvement in treatment satisfaction and some quality of life domains (dietary freedom and daily hassle) at 12 and 24 months. Conclusions Both groups showed clinically relevant and long lasting decreases in HbA1c, rates of severe hypoglycaemia, and improved psychological measures, although few participants achieved glucose levels currently recommended by national and international guidelines. Adding pump treatment to structured training in flexible intensive insulin treatment did not substantially enhance educational benefits on glycaemic control, hypoglycaemia, or psychosocial outcomes in adults with type 1 diabetes. These results do not support a policy of providing insulin pumps to adults with poor glycaemic control until the effects of training on participants’ level of engagement in intensive self management have been determined.

Expert commentary

Diabetes services are often judged according to how many patients are being treated with insulin pump therapy. The assumption has always been that this more expensive system of insulin delivery is the gold standard and the higher the proportion being treated with a pump, the better the service. This study suggests that it is the standard of education that is important, rather than the technology.

Furthermore, it shows that even with the best education and technology, the glycaemic targets routinely advocated by the National Institute for Health and Care Excellence for people with type 1 diabetes are impossible to achieve.

Steve Bain, Professor in Medicine (Diabetes), Swansea University

Expert commentary

Out of the 3.6 million people living with diabetes in the UK, 10% have type 1 diabetes. Sub-cutaneous insulin infusion pump therapy can be a useful way of managing diabetes in some of these people; however, it comes at a premium in comparison to the use of multiple daily insulin injections in a cash-stripped NHS. This randomised controlled study affirms some of my own impressions when I am seeing patients in my weekly type 1 diabetes clinic.

Structured patient education remains a key priority. Where limitations remain in optimising care in a motivated and actively engaging patient, one should consider pump therapy. Further studies in this area are warranted.

Dr Mujahid Saeed, Consultant Physician in Diabetes, Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust

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