Insulin pumps. Norman Waugh Warwick Medical School.

Transcription

1 Insulin pumps Norman Waugh Warwick Medical School

2 Insulin pumps Small device to support continuous subcutaneous insulin infusion Alternative to multiple daily injections (MDI) in type 1 diabetes Marginal cost vs MDI including pump and consumables about 1700 year 1, 1200 subsequent years.

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4 International comparisons UK has far lower proportion on pumps than other western countries USA 60 % in some centres Slovenia, Sweden etc higher NICE guidance perhaps 6% of adults with T1 So should UK increase?

5 Cochrane review

6 Insulin pumps 1 RCTs show Modest improvement in control of blood sugar Little difference in hypos Little difference in patient preference

7 Insulin pumps 2 Other evidence Case series much bigger reduction in hypos User submissions big effect on quality of life HRQoL versus other QoL

8 PU1 Insulin pumps 3 I managed to maintain a perfect HbA1c for a good 10 years before changing to CSII, and my HbA1c level has not changed. However, CSII has had a dramatic effect on my control by reducing the frequency of hypos. My wife had to administer glucagon to me on average twice a month; I have only needed one glucagon injection in 20 months on the pump.

9 Insulin pumps 4 PU7 When I was on MDI, blood glucoses were erratic. In one day I could easily go from being hypo to over 20. On the pump, I have very few highs and lows. Diabetes is a constant balancing act.you have to make small changes to your diabetic control all the time and with pump therapy this is very simple and very easy.

10 Insulin pumps 5 PU9..the pump has allowed me to lead a full and active life where I control my diabetes rather than the diabetes controlling me.

11 RCTs versus case series RCTs Recruit as many as you can from the clinic to prove efficacy Case series Recruit people with particular problems More scope to benefit Better guide to use in routine care?

12 NICE guidance 1.1 Continuous subcutaneous insulin infusion therapy is recommended as a treatment option for adults and children 12 years and older with type 1 diabetes mellitus provided that: attempts to achieve target haemoglobin A1c (HbA1c) levels with multiple daily injections (MDIs) result in the person experiencing disabling hypoglycaemia. For the purpose of this guidance, disabling hypoglycaemia is defined as the repeated and unpredictable occurrence of hypoglycaemia that results in persistent anxiety about recurrence and is associated with a significant adverse effect on quality of life or HbA1c levels have remained high (that is, at 8.5% [69 mmol/mol] or above) on MDI therapy (including, if appropriate, the use of long-acting insulin analogues) despite a high level of care.

13 CSII problems with evidence Only three trials of CSII vs best MDI Small numbers and short-term Imbalance of education Research needs to HTA Programme

14 Forest plot MDI analogue trials vs CSII CSII MDI Mean Difference Mean Difference Study or Subgroup Mean SD Total Mean SD Total Weight IV, Random, 95% CI IV, Random, 95% CI Bolli % [-0.62, 0.22] Thomas % [-1.10, 0.70] Total (95% CI) % [-0.58, 0.18] Heterogeneity: Tau² = 0.00; Chi² = 0.00, df = 1 (P = 1.00); I² = 0% Test for overall effect: Z = 1.03 (P = 0.30) Favours CSII Favours MDI

15 REPOSE trial Relative Effectiveness of Pumps Over Structured Education CSI + DAFNE versus MDI + DAFNE Exclude patients for whom CSII recommended by NICE if clear clinical need, not in REPOSE

16 HbA1c Mean HbA1c over time in participants with baseline HbA1c 7.5% (those with data at all four visits, n=208) Mean change in the CSII group -0.84% Mean change in MDI group was -0.42% After adjusting for centre, DAFNE course and baseline HbA1c, mean difference in HbA1c change from baseline -0.23% (95% CI to 0.05) ( P=0.121)

17 Messages Pumps justified in some people as per NICE New NICE guideline will increase that number if followed But large scale expansion to US level not justified But structured education should be rolled out.

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