Karen Anthony – Consultant in Diabetes & Endocrinology, Whittington Hospital, London

Hadleigh Stollar – Project Manager, Technology Adoption Centre

Insulin Pump Therapy and Real-time Glucose Monitoring Project.

Background to Project

• Recommended NICE Guidelines: where Multiple Daily Injections is failing, 15.15% of type 1 diabetes patients should have access to an insulin pump.

• This recommendation requires a huge amount of change sifting through the NHS in a colossal of policies and procedures, clinic and outpatient timetable restructures, financial and economic modelling – a real set of adoption barriers.

Insulin Pump and NTAC

• Following a review of the evidence for the Insulin Pump, NTAC decided to take this technology on as an Implementation Project – to work through the adoption barriers and bring about the change needed.

• As a result of Due Diligence on Trust’s who applied to be part of this project the following were recommended and chosen to participate:

– The Whittington Hospital, London,– Birmingham Children’s Hospital, – East Lancs Hospitals Trust, Blackburn & Darwin PCT and

East Lancs Teaching Hospital

Mentor Trusts

• Three mentor sites (who have great experience of setting up an insulin pump service) were also identified (Guys and St Thomas’s; Kings College Hospital, Kings College Hospital Foundation Trust and Salford Royal NHS Foundation Trust and Salford PCT) to establish how a significant step change can be made in delivery of the service and what role sensors play in managing difficult to control patients.

Project Landscape

Salford Royal NHS Foundation Trust and Salford PCT

King's College Hospital NHS

Foundation Trust

Guys and St Thomas’s

The Whittington Hospital, London.

Birmingham Children’s Hospital.

East Lancs Hospitals Trust, Blackburn & Darwin PCT and

East Lancs Teaching Hospital.

3 sites in England who have

successfully adopted Insulin

Pumps with continuous

Glucose Monitoring, with

the mentor

HOW2WHY2 GUIDE

Project Sites

• Project teams have been established with each of the Trusts above, and the project plans are now being developed. Carefully planning of tasks will be crucial to ensure success.

• Each Trust presents different barriers to adoption – covering paediatric to adult transition, pregnancy, and ethnic minority patient mix’s.

Project Vision

“The Insulin Pump Therapy with Continuous Glucose Monitoring Project will deliver a high

quality clinical service that best meets the needs of patients. Trust’s partaking in the

project, will aim to reconfigure their practice wherever necessary and will strive, where possible, to meet the recommended NICE

guidelines. Each Trust will aim to reach this through continuous improvement driven by

integrity, teamwork, and innovation”.

Diabetes in the UK

• UK 2008

2.48 million diagnosed patients

Prevalence 3.8%

• 500,000 more are undiagnosed

• Approx 85% Type 2 DM, 15% Type 1 DM

A Few Facts and Figures

• NHS Diabetes expenditure £1 million per hour.

• 9% of total NHS budget.

• Diabetes is a leading and preventable cause of:

Blindness

Renal failure

Amputation

Diabetes Control and Complication Risk

Type 1 Diabetes

• Autoimmune disorder destroys islets

• Results in absolute insulin deficiency.

• Onset typically in childhood/young adulthood.

• Managed by insulin replacement.

• Aim is to mimic endogenous insulin secretion as closely as possible.

Multiple Daily Injection Therapy

• Background insulin once daily injection.

• Rapid acting insulin at meals/snacks

Dose calculated according to carbohydrate content and patient’s insulin sensitivity.

• Education in dose calculation and adjustment essential.

• Many patients have good control and quality of life with MDI treatment.

HbA1c and Hypoglycaemia

Insulin Pumps- Principles

• Continuous subcutaneous insulin delivery.

Alternative option to MDI therapy.

• Pager sized device won continuously.

• Rapid acting insulin only.

• Basal insulin delivery programmed according to user’s needs.

• Mealtime boluses delivered via pump.

Insulin Pumps- Benefits

• Reduced hypoglycaemia frequency.Individualised basal rate variable throughout 24 hour period.

• Improved HbA1cMost recent data points to 0.6-1.2% drop in HbA1c

• Flexibility of lifestyleeg temporary reduction basal insulin around exercise

RCT of CSII vs MDI with glargine

Insulin Pumps-Myths

• Acts like an ‘artificial pancreas’

No ‘closed loop’ devices currently available.

• Less work for patients

Patient selection key

Requires motivation, commitment, competence and realistic expectations.

Realtime Glucose Monitoring

• Uses interstitial fluid monitoring to produce realtime glucose .

• Updated every 5 minutes

• Can be used in conjunction with pump.

NICE Guidance 2008- adults

Insulin pump therapy is recommended as a treatment option for adults and children 12 years and older with type 1 diabetes provided:

– attempts to achieve target haemoglobin A1c (HbA1c) levels with multiple daily injections (MDIs) result in the person experiencing disabling hypoglycaemia

or

– HbA1c levels have remained high (8.5% or above) on MDI therapy despite a high level of care.

NICE Guidance 2008- Children under 12

CSII therapy is recommended as a treatment option for children younger than 12 years with type 1 diabetes provided:

• MDI therapy is considered to be impractical or inappropriate, and

• children on insulin pumps would be expected to undergo a trial of MDI therapy between the ages of 12 and 18 years.

Insulin Pump Provision in the UK

– 350,000 people in the UK have type 1 diabetes

– Current UK usage of insulin pumps is dramatically lower than other countries of comparable economic standing and healthcare provision.

Estimated insulin pump usage in different countries (J Pickup)

UK Adoption of Insulin pumps

• 2006 estimate 4000 users

• 2008 estimate ? Up to 8000.

• Huge variation in provision across UK. Some areas only 0.1% eligible pts use CSII.

• NICE costing tool suggests potential uptake 8-15% of Type 1 pts (and 15-50% of children under 12yr).

• 4-6 fold increase in pump treated patients?

Barriers to pump adoption in the UK- Financial

• Cost (ave annual cost £1100-1400 above that of MDI).But health economic/QALY calculations show that pump therapy is cost-effective.

• Reduced costs of hypoglycaemia.• Reduced costs associated with reduced

risk complications• Cost of pump is ‘upfront’ but gains are

long term – over many years.

Barriers to pump adoption in the UK- Staffing

• Staffing and training

• Trained multidisciplinary team mandatory

Physician

Diabetes specialist nurses

Dietitian

• All require training for insulin pump therapy including education of patients.

Barriers to pump adoption in the UK- Care Pathways/Working Practices

• Pump treatment doesn’t ‘fit’ within standard outpatient clinic model.

• Patients’ requirements vary over time. Eg frequent visits at pump start.

• Joint consultations with flexible use of physician/DSN/dietitian according to need.

• Ongoing education vital.

• Use of virtual consultations harnessing download technology.

Commissioning for Insulin Pump Services

• The environment to date:Often difficult to agree funding for patients.Usually on patient by patient basis.Secondary care contacts PCT about each

patient. Arrangements vary considerably.

Commissioning for Insulin Pump Services

• CSII is a specialised service exclusion under PbR.

• More work needed to understand costs of pump initiation and ongoing care.Not just hardware & consumablesPatient education.Telephone/email adviceCosting multi-disciplinary clinics

• Can then inform development of tariff.

Potential Benefits of Project

Insulin pump therapy seen as a routine clinical option.

Greater understanding of care pathwaysAgreed and affordable commissioning

pathway and tariff (regional/national).Improved secondary care/PCT links.Recognised audit criteria and standards.

• Improve outcomes and quality of life for patients with Type 1 diabetes