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Developing an insulin pump therapy service

Donna Hodgkiss
Diabetes Specialist Nurse

Juliet Morris
Diabetes Specialist Nurse
Manchester Diabetes Centre

Continuous subcutaneous insulin infusion (CSII) is a treatment option for intensive management of diabetes. Insulin regimens can be tailored to the individual by programming the basal rate to deliver varying amounts of insulin at specified times. This allows complete flexibility with all aspects of daily living. When patients choose to eat they can deliver a bolus of insulin according to carbohydrate intake. Many studies have shown the effectiveness of CSII in improving control and reducing hypoglycaemia, resulting in the reduced risk of long-term diabetes complications.(1,2)
The main benefit of CSII is pharmacokinetic. Pumps use fast-acting analogue insulin and are programmed to deliver tiny, precise pulses of insulin 24 hours a day as required. A bolus of insulin is given at mealtimes or with snacks to maintain desired glucose levels. Precision of this kind more closely mimics a healthy pancreas, and maintaining tight glycaemic control reduces the incidence of short-term and long-term diabetes complications.(3)
Developments in insulin pump technology have progressed rapidly in recent years. Historically, physicians and pump patients have had to estimate how much bolus insulin is required. The newest pumps have a "bolus wizard calculator" that is designed to simplify meal and correction bolus dosing by using information such as an individual's insulin sensitivity, current and target blood glucose levels and previous bolus insulin.
Since the recommendation of insulin pump therapy by NICE as an option for people with type 1 diabetes who have not succeeded with multiple-dose therapy including glargine, or who have unpredictable hypoglycaemia, hospital consultants are now considering setting up pump clinics in their service.(4) The Manchester Diabetes Centre (MDC) has been using CSII since 1998. This article outlines the setting up of a pump service in Manchester, the results of an audit of the service, including how the funding was made available, and looks to the future of the service. It also discusses new and future developments in pump therapy.

How it all began
The first use of insulin pumps in the MDC was in 1998 and was born out of desperation in trying to stabilise a 23-year-old woman diagnosed with type 1 diabetes at the age of 2 years. She was needle-phobic, had numerous psychological problems, including a history of self-harm, and recurrent diabetic ketoacidosis (DKA), which was becoming more frequent with poor venous access. Each episode brought the concern that it would be the last. Far from her being an ideal candidate for CSII, the main priority at that time was keeping her alive and providing a means of ensuring she had a constant source of insulin. MiniMed agreed to provide a 506 pump, and initially she came to the centre every 3 days to have her infusion set changed.
At that time there were no specific training courses in existence, so we read the instruction manual and proceeded to do the best of our ability. The first attempt was unsuccessful as she ended up in hospital in DKA. Since then, in the subsequent 6-year period, she has only had one episode of DKA and one admission unrelated to diabetes. We have no doubt the pump has kept her alive: she still has lots of psychological issues and her control is still poor, but at least she now has a chance!

Overview of the service
Since its first patient in 1998, the MDC decided it would instigate the policy of offering the option of pump therapy for suitable patients. The pumps were either funded from an endowment fund, by taking part in clinical trials or by the patients themselves. The consumables were funded from the MDC ­budget.

Audit 2003

What we looked at

  • Number of patients on CSII.
  • Which PCT was responsible for diabetes care.
  • Reason for CSII.
  • Who provided the funding for the pump and ­consumables.
  • Changes in glycaemic control.
  • Does the patient meet NICE criteria?

Summary of Findings
Of 34 current users of CSII (at time of audit):

  • 7 were funded by their own PCTs.
  • 4 patients paid for their own treatment.
  • 23 were funded by the MDC (9 of these patients purchased their own pumps).
  • Only 2 patients did not fit NICE criteria, both funded by the MDC.

Reasons for pump therapy

  • Poor glycaemic control.
  • Developing complications.
  • To improve glycaemic control preconceptually.
  • Pregnancy.
  • Severe hypoglycaemia.
  • Painful neuropathy.
  • Patient choice.

Changes to Hba(1c)

  • Mean HbA(1c) before pump therapy: 9.8% (6.5-14.5%).
  • Mean HbA(1c) after pump therapy: 8.3% (6-11.7%).
  • Difference of 1.5% (+0.7 to -3.7).

What this audit did not show was the improvement in quality of life, which in clinical practice came across very strongly. What the audit did show was that due to the fact we had become a specialist pump centre we were funding patients from numerous other trusts, with resulting overspend. At this point the Head of Commissioning wrote to all the PCTs to establish funding for our existing patients. However, most refused, stating that funding should be available from the NICE uplift money. No budget allocation had been set aside for pump therapy for the financial year, which resulted in a decision that new pump starts would have to wait until funding had been agreed between the trust and the PCT on an individual case-by-case basis. There was only one new pump start in 2003.

The current situation
There are 36 patients on CSII at the present time, June 2004, of which 25 are funded by MDC (10 purchased their own pumps, one from another trust) and 9 by the PCT. Two patients continue to fund their own pump and consumables.
We are currently preparing a business case to secure money from the NICE uplift for the next financial year. This involves calculating the predicted costs for Central Manchester and the demands from other trusts. The other trusts are now setting up their own services, resulting in a decrease in the number of patients referred for pump therapy to the MDC. In the meantime we have an increasing waiting list for patients eligible for pump therapy under the NICE guidance.

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What would we do differently?

Funding

Apply and secure funding over and above the MDC budget for an agreed number of patients per year.

Health professionals
There are now numerous pump courses available across the country providing 2-3-day training for health professionals, and clinical support provided by nurses employed by the pump company. There are also 24-hour technical support helplines available for the patients.

Patients
Nothing! We still believe in patient choice regarding treatment options. Patients report a greater sense of freedom, reduced anxiety and better ability to manage ­diabetes more easily with CSII pumps compared with the restrictions imposed by traditional daily injections.(5)

Conclusion
NICE recommends that insulin pumps be made available in certain circumstances. Insulin pumps should be considered for people with type 1 diabetes who are competent to use the therapy with the support and guidance of their specialist diabetes team.
With the advancement of new technology, the latest insulin pumps have reduced and simplified training and education by including facilities for suggested mealtime and correction bolus dosing calculations.
The ultimate goal is to integrate future insulin pumps with continuous glucose sensors, so as to create an external closed-loop system and an artificial pancreas.

References

  1. Bode BW, Steed RD, Davidson PC. Reduction in severe hypoglycaemia with long term continuous subcutaneous insulin infusion in type 1 diabetes. Diabetes Care 1996;19:324-7.
  2. Linkeschova R, Raoul M, Bott U, Berger M, Spraul M. Less severe hypoglycaemia, better metabolic control and improved quality of life in type 1 diabetes mellitus with CSII; an observational study of 100 consecutive patients following a mean of 2 years. Diabet Med 2002:19:741-6.
  3. The Diabetes Control and Complications Trial Research Group.The effect of intensive ­treatment of diabetes on the development and progression of long-term ­complications in insulin-dependent diabetes mellitus.N Engl J Med 1993; 329:977-86.
  4. Nice Technology Appraisal Guidance - No 57: Continuous subcutaneous insulin infusion (insulin pump therapy) for diabetes. February 2003.
  5. Garmo A, Pettersson-Frank B, Ehrenberg A. Treatment effects and the ­satisfaction in diabetic patients changing from multiple daily injections to CSII.  Pract Diabetes Int 2004;21(1):7-12.