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Child with insulin pump

NIHR Signal Insulin pumps offer little value over multiple injections for children at the onset of diabetes

Published on 20 November 2018

doi: 10.3310/signal-000680

Young people newly diagnosed with type 1 diabetes achieve similar blood glucose control by 12 months if they are treated with multiple daily insulin injections or continuously via an insulin pump. Adverse events are rare and occur at similar rates. Pumps are more expensive with no clear benefit to quality of life.

Both regimens are used in the management of type 1 diabetes, and the number of children using insulin pumps is rising. This NIHR-funded trial suggests that at an additional cost of £1,863 per patient annually with equivalent outcomes, the high costs of insulin pumps seem unjustified at this stage of the condition.

However, continuous insulin may be more convenient for some, particularly younger children, or later in their diabetes, so insulin pumps are still likely to have a place in treatment. Current guidelines recommend that multiple injections are considered first, with a switch to an insulin pump if these injections are inappropriate.

Share your views on the research.

Why was this study needed?

In England and Wales in 2016/17 there were 2,807 new diagnoses of type 1 diabetes among young people aged up to 15 years, an incidence of 25.4 per 100,000 population. A third of young people currently use insulin pumps (continuous subcutaneous insulin infusion), double the number compared with 2013/14. Younger children, girls, those of white ethnicity and living in less deprived areas are more likely to be using pumps. Treating type 1 diabetes in young people costs the NHS between £52 and £70 million annually. Costs would double if all used insulin pumps.

The National Diabetes Insulin Pump Audit (2016/17) reported that people using insulin pumps more often achieve their treatment goals and have lower blood glucose. However, a recent Signal on adults with type 1 diabetes reported that blood glucose control was no better with pumps than with multiple daily injections (basal bolus regimens). This study looked at this issue in children.

What did this study do?

The SCIPI randomised controlled trial included 293 children and young people (aged 15 years or younger; average 9.8 years) newly diagnosed with type 1 diabetes, recruited from 15 centres in England and Wales. They received multiple daily injections (4 or more injections daily including both short- and long-acting insulin) or continuous subcutaneous infusion of short-acting insulin via a pump. All participants (and/or carers) were educated about type 1 diabetes and insulin administration. Follow-up was to 12 months.

The researchers aimed to detect a clinically meaningful difference of 0.5% (5 mmol/mol) in glycated haemoglobin (HbA1c), a long-term measure of blood glucose control. More than half of patients/carers invited to join the trial declined participation, mainly because of preference for multiple injections.

What did it find?

  • At 12 months, age-adjusted HbA1c was similar in both groups: average 60.9 mmol/mol for patients on the insulin pump and 58.5 mmol/mol for those receiving multiple daily injections (difference +2.4, 95% confidence interval [CI] -0.4 to +5.3).
  • There was no meaningful difference in the number achieving the target HbA1c of less than 48 mmol/mol (6.5%): 15.4% insulin pump vs 20.4% multiple injections (relative risk [RR] 0.75, 95% CI 0.46 to 1.25). Neither was there a difference in the proportion achieving partial remission and needing a low insulin dose (24.4% pump vs 32.8% injections; RR 0.74, 95% CI 0.45 to 1.24).
  • Slightly more patients treated with insulin pumps experienced severe low blood glucose (hypoglycaemia: 4.2% vs 1.3%) or life-threatening high blood glucose (diabetic ketoacidosis: 1.4% vs 0%). However, these differences were not statistically significant, and the low numbers need cautious interpretation.
  • Parent-reported quality of life was slightly better for children on insulin pumps compared with injections. The difference was +4.1 (95% CI +0.6 to +7.6) on the 100-point Pediatric Quality of Life Inventory (PedsQL) which measures physical, emotional, social and school functioning. Scores on the child-reported PedsQL (which starts from age 5) fell short of significance (+3.1, 95% CI -0.6 to +6.8).
  • Multiple daily injections were calculated to be a more cost effective use of NHS resources. Insulin pumps cost an additional £1,863 per patient per year with no gain in years of quality life (QALYs: -0.006, 95% CI -0.031 to +0.018).
  • Many children and families declined to take part in the study, and many of these people had a strong preference for daily injections, which may affect the generalisability of the findings.

What does current guidance say on this issue?

NICE guidelines on the management of type 1 diabetes in children (updated 2016) recommend that basal bolus regimens are offered from diagnosis, with continuous subcutaneous insulin infusion considered if this is inappropriate.

Earlier 2008 guidance outlines specific criteria for the use of pumps. Young people over 12 years would be expected to initially try basal bolus and only switch to a pump if:

  • they are experiencing disabling hypoglycaemia; or
  • HbA1c is exceeding 8.5% (69mmol/mol) despite optimal therapy.

There is a lower threshold for introducing a pump in children under 12 years, and it may be used if multiple injections are impractical or inappropriate.

What are the implications?

The findings indicate that diabetes outcomes are no better with the use of insulin pumps, at least in the first year of having diabetes. It’s possible that the 12-month time horizon could hide later benefits, or that there may be reasons to switch to a pump later in the condition.

This evidence supports NICE guidance to use multiple injections for the newly diagnosed child, before considering insulin pumps. However, child and carer preferences are highly relevant and will need to be balanced against the additional cost if used for selected cases.

It is more important that the young person complies with treatment and experiences the best glucose control and quality of life, but injections are preferred by many families, highlighted by the fact that over half of eligible patients declined participation because of preference for the basal bolus insulin method.

Citation and Funding

Blair J, McKay A, Ridyard C et al. Continuous subcutaneous insulin infusion versus multiple daily injections in children and young people at diagnosis of type 1 diabetes: the SCIPI RCT. Health Technol Assess. 2018;22(42).

This project was funded by the National Institute for Health Research Health Technology Assessment programme (project number 08/14/39).

Bibliography

NHS Digital. National Diabetes Audit report 1 – findings and recommendations. 2016-17. London: NHS Digital; March 2018.

NHS Digital. National Diabetes Audit – insulin pump report 2016-17. London: NHS Digital; June 2018.

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

NICE. Diabetes (type 1 and type 2) in children and young people: diagnosis and management. NG18. London: National Institute for Health and Care Excellence; 2015, updated Nov 2016.

Royal College of Paediatrics and Child Health. National Paediatric Diabetes Audit (NPDA) national report 2016-17. London: Royal College of Paediatrics and Child Health; 2018.

Why was this study needed?

In England and Wales in 2016/17 there were 2,807 new diagnoses of type 1 diabetes among young people aged up to 15 years, an incidence of 25.4 per 100,000 population. A third of young people currently use insulin pumps (continuous subcutaneous insulin infusion), double the number compared with 2013/14. Younger children, girls, those of white ethnicity and living in less deprived areas are more likely to be using pumps. Treating type 1 diabetes in young people costs the NHS between £52 and £70 million annually. Costs would double if all used insulin pumps.

The National Diabetes Insulin Pump Audit (2016/17) reported that people using insulin pumps more often achieve their treatment goals and have lower blood glucose. However, a recent Signal on adults with type 1 diabetes reported that blood glucose control was no better with pumps than with multiple daily injections (basal bolus regimens). This study looked at this issue in children.

What did this study do?

The SCIPI randomised controlled trial included 293 children and young people (aged 15 years or younger; average 9.8 years) newly diagnosed with type 1 diabetes, recruited from 15 centres in England and Wales. They received multiple daily injections (4 or more injections daily including both short- and long-acting insulin) or continuous subcutaneous infusion of short-acting insulin via a pump. All participants (and/or carers) were educated about type 1 diabetes and insulin administration. Follow-up was to 12 months.

The researchers aimed to detect a clinically meaningful difference of 0.5% (5 mmol/mol) in glycated haemoglobin (HbA1c), a long-term measure of blood glucose control. More than half of patients/carers invited to join the trial declined participation, mainly because of preference for multiple injections.

What did it find?

  • At 12 months, age-adjusted HbA1c was similar in both groups: average 60.9 mmol/mol for patients on the insulin pump and 58.5 mmol/mol for those receiving multiple daily injections (difference +2.4, 95% confidence interval [CI] -0.4 to +5.3).
  • There was no meaningful difference in the number achieving the target HbA1c of less than 48 mmol/mol (6.5%): 15.4% insulin pump vs 20.4% multiple injections (relative risk [RR] 0.75, 95% CI 0.46 to 1.25). Neither was there a difference in the proportion achieving partial remission and needing a low insulin dose (24.4% pump vs 32.8% injections; RR 0.74, 95% CI 0.45 to 1.24).
  • Slightly more patients treated with insulin pumps experienced severe low blood glucose (hypoglycaemia: 4.2% vs 1.3%) or life-threatening high blood glucose (diabetic ketoacidosis: 1.4% vs 0%). However, these differences were not statistically significant, and the low numbers need cautious interpretation.
  • Parent-reported quality of life was slightly better for children on insulin pumps compared with injections. The difference was +4.1 (95% CI +0.6 to +7.6) on the 100-point Pediatric Quality of Life Inventory (PedsQL) which measures physical, emotional, social and school functioning. Scores on the child-reported PedsQL (which starts from age 5) fell short of significance (+3.1, 95% CI -0.6 to +6.8).
  • Multiple daily injections were calculated to be a more cost effective use of NHS resources. Insulin pumps cost an additional £1,863 per patient per year with no gain in years of quality life (QALYs: -0.006, 95% CI -0.031 to +0.018).
  • Many children and families declined to take part in the study, and many of these people had a strong preference for daily injections, which may affect the generalisability of the findings.

What does current guidance say on this issue?

NICE guidelines on the management of type 1 diabetes in children (updated 2016) recommend that basal bolus regimens are offered from diagnosis, with continuous subcutaneous insulin infusion considered if this is inappropriate.

Earlier 2008 guidance outlines specific criteria for the use of pumps. Young people over 12 years would be expected to initially try basal bolus and only switch to a pump if:

  • they are experiencing disabling hypoglycaemia; or
  • HbA1c is exceeding 8.5% (69mmol/mol) despite optimal therapy.

There is a lower threshold for introducing a pump in children under 12 years, and it may be used if multiple injections are impractical or inappropriate.

What are the implications?

The findings indicate that diabetes outcomes are no better with the use of insulin pumps, at least in the first year of having diabetes. It’s possible that the 12-month time horizon could hide later benefits, or that there may be reasons to switch to a pump later in the condition.

This evidence supports NICE guidance to use multiple injections for the newly diagnosed child, before considering insulin pumps. However, child and carer preferences are highly relevant and will need to be balanced against the additional cost if used for selected cases.

It is more important that the young person complies with treatment and experiences the best glucose control and quality of life, but injections are preferred by many families, highlighted by the fact that over half of eligible patients declined participation because of preference for the basal bolus insulin method.

Citation and Funding

Blair J, McKay A, Ridyard C et al. Continuous subcutaneous insulin infusion versus multiple daily injections in children and young people at diagnosis of type 1 diabetes: the SCIPI RCT. Health Technol Assess. 2018;22(42).

This project was funded by the National Institute for Health Research Health Technology Assessment programme (project number 08/14/39).

Bibliography

NHS Digital. National Diabetes Audit report 1 – findings and recommendations. 2016-17. London: NHS Digital; March 2018.

NHS Digital. National Diabetes Audit – insulin pump report 2016-17. London: NHS Digital; June 2018.

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

NICE. Diabetes (type 1 and type 2) in children and young people: diagnosis and management. NG18. London: National Institute for Health and Care Excellence; 2015, updated Nov 2016.

Royal College of Paediatrics and Child Health. National Paediatric Diabetes Audit (NPDA) national report 2016-17. London: Royal College of Paediatrics and Child Health; 2018.

Continuous subcutaneous insulin infusion versus multiple daily injections in children and young people at diagnosis of type 1 diabetes: the SCIPI RCT

Published on 15 August 2018

Blair J, McKay A, Ridyard C, Thornborough K, Bedson E, Peak M, Didi M, Annan F, Gregory J W, Hughes D & Gamble C

Health Technology Assessment Volume 22 Issue 42 , 2018

Background The risk of developing long-term complications of type 1 diabetes (T1D) is related to glycaemic control and is reduced by the use of intensive insulin treatment regimens: multiple daily injections (MDI) (≥ 4) and continuous subcutaneous insulin infusion (CSII). Despite a lack of evidence that the more expensive treatment with CSII is superior to MDI, both treatments are used widely within the NHS. Objectives (1) To compare glycaemic control during treatment with CSII and MDI and (2) to determine safety and cost-effectiveness of the treatment, and quality of life (QoL) of the patients. Design A pragmatic, open-label randomised controlled trial with an internal pilot and 12-month follow-up with 1 : 1 web-based block randomisation stratified by age and centre. Setting Fifteen diabetes clinics in hospitals in England and Wales. Participants Patients aged 7 months to 15 years. Interventions Continuous subsutaneous insulin infusion or MDI initiated within 14 days of diagnosis of T1D. Data sources Data were collected at baseline and at 3, 6, 9 and 12 months using paper forms and were entered centrally. Data from glucometers and CSII were downloaded. The Health Utilities Index Mark 2 was completed at each visit and the Pediatric Quality of Life Inventory (PedsQL, diabetes module) was completed at 6 and 12 months. Costs were estimated from hospital patient administration system data. Outcomes The primary outcome was glycosylated haemoglobin (HbA1c) concentration at 12 months. The secondary outcomes were (1) HbA1c concentrations of < 48 mmol/mol, (2) severe hypoglycaemia, (3) diabetic ketoacidosis (DKA), (4) T1D- or treatment-related adverse events (AEs), (5) change in body mass index and height standard deviation score, (6) insulin requirements, (7) QoL and (8) partial remission rate. The economic outcome was the incremental cost per quality-adjusted life-year (QALY) gained. Results A total of 293 participants, with a median age of 9.8 years (minimum 0.7 years, maximum 16 years), were randomised (CSII, n = 149; MDI, n = 144) between May 2011 and January 2015. Primary outcome data were available for 97% of participants (CSII, n = 143; MDI, n = 142). At 12 months, age-adjusted least mean squares HbA1c concentrations were comparable between groups: CSII, 60.9 mmol/mol [95% confidence interval (CI) 58.5 to 63.3 mmol/mol]; MDI, 58.5 mmol/mol (95% CI 56.1 to 60.9 mmol/mol); and the difference of CSII – MDI, 2.4 mmol/mol (95% CI –0.4 to 5.3 mmol/mol). For HbA1c concentrations of < 48 mmol/mol (CSII, 22/143 participants; MDI, 29/142 participants), the relative risk was 0.75 (95% CI 0.46 to 1.25), and for partial remission rates (CSII, 21/86 participants; MDI, 21/64), the relative risk was 0.74 (95% CI 0.45 to 1.24). The incidences of severe hypoglycaemia (CSII, 6/144; MDI, 2/149 participants) and DKA (CSII, 2/144 participants; MDI, 0/149 participants) were low. In total, 68 AEs (14 serious) were reported during CSII treatment and 25 AEs (eight serious) were reported during MDI treatment. Growth outcomes did not differ. The reported insulin use was higher with CSII (mean difference 0.1 unit/kg/day, 95% CI 0.0 to 0.2 unit/kg/day; p = 0.01). QoL was slightly higher for those randomised to CSII. From a NHS perspective, CSII was more expensive than MDI mean total cost (£1863, 95% CI £1620 to £2137) with no additional QALY gains (–0.006 QALYs, 95% CI –0.031 to 0.018 QALYs). Limitations Generalisability beyond 12 months is uncertain. Conclusions No clinical benefit of CSII over MDI was identified. CSII is not a cost-effective treatment in patients representative of the study population. Future work Longer-term follow-up is required to determine if clinical outcomes diverge after 1 year. A qualitative exploration of patient and professional experiences of MDI and CSII should be considered. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 42. See the NIHR Journals Library website for further project information. The cost of insulin pumps and consumables supplied by F. Hoffman-La Roche AG (Basel, Switzerland) for the purpose of the study were subject to a 25% discount on standard NHS costs.

Expert commentary

Recruitment was challenging. Many families declined to join the study because they had a treatment option preference (66% preferring multiple injection therapy). Pump usage in the UK is still at relatively low levels (30%). Would greater confidence in pump therapy improve the outcome? – I doubt it!

The reasons for wide variation in children’s diabetes outcomes across Europe are probably more complex.

About 50% of participants achieved HbA1c less than 58 mmol/mol - better than the 2016-2017 UK Audit data (28.9%), but we still have a long way to go. As the investigators suggest, we should be putting more resources into understanding why the outcomes during the first year remain poor.

David Dunger, Professor of Paediatrics, University of Cambridge

The commentator declares no conflict of interest

Expert commentary

Management of children newly diagnosed with type 1 diabetes is challenging, particularly in the UK where outcomes lag behind the best European centres.

This study addresses the challenge by comparing state of the art continuous insulin infusion from diagnosis with traditional multiple daily injections. The lack of difference in glucose control after one year is to be expected given that most children will still be in their honeymoon. The improved quality of life reported by carers of children on pump therapy will be greatly welcomed by families and health professionals.

This improvement is an essential prerequisite for delivering intensive glucose management, which is known to reduce long term complications and their associated healthcare costs.

Timothy Barrett, Leonard Parsons Professor of Paediatrics, University of Birmingham; Honorary Consultant Paediatric Endocrinology and Diabetes, Birmingham Women’s and Children’s NHS Foundation Trust