Post-market Review Products Used in the Management of Diabetes Report to Government Stage 2: Insulin Pumps February 2015

6.2 Introduction

This section of the report aims to consider clinical criteria and eligibility under the Programme to ensure these remain clinically appropriate and supported by current evidence. The aim is to provide the best possible access to insulin pump therapy under the Programme, within the funding limits, by identifying those who would benefit most as supported by clinical evidence.

The literature reviews of RCTs and observational studies undertaken by the QUMPRC aimed to identify sub-groups who may have greater benefit from insulin pump therapy. The Department also sought advice on appropriate clinical eligibility criteria for the Programme through stakeholder input, and expert advice from the Reference Group and APEG.

A number of national and international guidelines have been published on the management of type 1 diabetes and the use of insulin pumps in both paediatric and adult populations. This section summarises and compares a number of Australian and key international guidelines concerning the treatment of type 1 diabetes, with particular focus on recommendations on initiation of insulin pump therapy versus multiple daily injections. This section also compares access to, and eligibility criteria for, insulin pump subsidy programmes in other countries.

6.2.1 Current clinical eligibility criteria for the Insulin Pump Programme

To be eligible for a subsidy under the Insulin Pump Programme, the patient must be under the age of 18 at the date of application, and meet the following clinical eligibility criteria:

• 
  the child has type 1 diabetes;
  
• 
  the child will benefit from a transition to insulin pump therapy;
  
• 
  the child/carer has demonstrated willingness to check blood glucose levels four or more times per day;
  
• 
  the child/carer has demonstrated competence at injecting insulin using pens/syringes;
  
• 
  the insulin pump initiation will be conducted by a multidisciplinary team; and
  
• 
  the initiating team makes a commitment to a transition and a system to ensure follow-up and ongoing support.
  

6.3 Literature review: RCTs and observational studies

The literature reviews of RCTs and observational studies aimed to determine if there are any sub-groups of patients who may benefit more from insulin pump therapy and should be prioritised to receive a pump under the Programme (Refer to Part 4 for additional detail). There were no sub-group or sensitivity analyses in the reviews of RCTs or observational studies that considered children’s characteristics other than age. Two small observational studies suggest that insulin pump therapy may be more beneficial in children under 6 years old (Hughes 2012), or when initiated in children under 6 years old (Levy-Shagra 2013).

There is little evidence in the literature reviews to suggest there is a sub-group in the type 1 diabetes population that would receive significantly greater benefits from insulin pump therapy than other groups. Observational studies, which generally showed greater benefits in HbA_1c reduction in patients using insulin pump therapy than the results from RCTs, often used clinical criteria when selecting patients for insulin pump therapy, including: poor glycaemic control, frequent hypoglycaemia, dawn phenomenon, need for lifestyle flexibility and needle phobia.

6.4 Literature review: Australian and international clinical guidelines

The literature review for ToR 10 identified and compared recommendations for the use of insulin pump therapy from health professional and health technology assessment organisations in Australia and in countries with similar healthcare systems. Five guidelines on the use of insulin pump therapy were identified in Australia, Scotland, England, and the United States. New Zealand also has a position statement on insulin pump therapy. A summary of the guidelines is at Appendix D. In additional to the Australian guidelines identified in the literature review, other notable guidelines, including those listed on the NHMRC guideline portal for the diagnosis and management of type 1 diabetes, were also considered. Information on the guidelines currently hosted by the NHMRC guideline portal is at Appendix E.

The guidelines were in agreement that insulin pump therapy could be considered for improving glycaemic control, based on the results of meta-analyses and RCTs. Evidence for improving hypoglycaemia was based on the results of observational studies, primarily before-and-after studies. Evidence of this level is generally considered of low or very low quality as it has a high risk of bias resulting in the measured difference being larger due to other factors than the change to pump delivery. The guidelines provide criteria for selecting patients who may be likely to benefit from insulin pump therapy based on guideline committee members’ consensus opinion.

6.4.1 Australian clinical guidelines summary

The decision to commence insulin pump therapy is made in consultation with a multidisciplinary team of health professionals. People with type 1 diabetes, or their families, who wish to benefit from lifestyle improvements, may also request an insulin pump. Once accepted, patients must be fitted with their pump by a health professional and must undertake training to use the insulin pump properly. Patients must keep regular contact with a health professional to ensure the pump is being used appropriately (AIHW 2012b).

The National Evidence-Based Clinical Care Guidelines for Type 1 Diabetes in Children, Adolescents and Adults (Craig 2011), endorsed by APEG and the Australian Diabetes Society (ADS), addresses clinical care across the lifespan for people with type 1 diabetes. Developed by medical experts and researchers for practising health professionals, the guideline was endorsed by the NHMRC in 2011.

The guideline recommends that insulin pump therapy be “…considered for use in individuals in whom the expected magnitude of benefit is clinically significant in terms of reducing HbA_1c, reducing hypoglycaemia or improving QoL [quality of life] (Grade C)”. Grade C indicates that the evidence provides some support for the recommendation(s), but care should be taken in their application (Craig 2011).

This guideline recommends that “individuals who may be likely to benefit from… insulin pump therapy, as part of intensive diabetes management are:

• 
  some children and adolescents, including infants and young children, and pregnant women (ideally preconception);
  
• 
  individuals with microvascular complications of diabetes;
  
• 
  individuals with reduced hypoglycaemia awareness;
  
• 
  individuals (or their supervising adults) with desirable motivational factors, for example, those seeking to improve blood glucose and having realistic expectations; and
  
• 
  individuals exhibiting desirable CSII [insulin pump therapy] treatment-related behavioural factors, including those who:
  
  • 
    are able to perform carbohydrate counting;
    
  • 
    are currently undertaking four or more blood glucose tests per day;
    
  • 
    have reliable adult supervision (in paediatrics), and a history of good selfmanagement skills (in adults);
    
  • 
    are able to master the technical skills of CSII [insulin pump therapy]; and
    
  • 
    are reliable in follow-up health care” (Craig 2011).
    

A group of diabetes health professionals and researchers in Victoria has also developed a guideline centralised around insulin pump therapy rather than type 1 diabetes management as a whole (Victorian CSII Working Party 2009). Generally, glycaemic control, complication status, quality of management, and other co-morbidities and lifestyle factors are considered before commencement of insulin pump therapy. Patients are expected to undergo a clinical assessment and diabetes education assessment before commencing insulin pump therapy. The guideline generally recommends insulin pump therapy use for:

• 
  those confirmed as having type 1 diabetes or diabetes in pregnancy;
  
• 
  those whose lifestyle, physical abilities, attitudes, psychiatric status, and cognitive abilities (e.g. basic numeracy and ability to undertake carbohydrate counting) allow for insulin pump therapy;
  
• 
  those who demonstrate consistent home blood glucose monitoring and recording; and
  
• 
  whose financial status can cover the co-payments for the insulin pump and consumables (Victorian CSII Working Party 2009).
  

There are a number of other guidelines for the diagnosis and management of type 1 diabetes on the NHMRC Guidelines Portal. To be listed on the Portal, guidelines are assessed against specific criteria (NHMRC 2011).

6.4.2 NPS MedicineWise

The NPS MedicineWise does not provide any information on insulin pump therapy for health professionals, but does have a consumer information page: Insulin pumps for type 1 diabetes (2013).

6.4.3 International clinical guidelines

6.4.3.1 England

A NICE technology appraisal guidance (2009) states that “continuous subcutaneous insulin infusion or ‘insulin pump' therapy is recommended as a possible treatment for adults and children 12 years and over with type 1 diabetes mellitus, if:

• 
  attempts to reach target haemoglobin A_1c (HbA_1c) levels with multiple insulin injections result in the person having ‘disabling hypoglycaemia'; or
  
• 
  HbA_1c levels have remained high (8.5% or above) with multiple insulin injections (including using long-acting insulin analogues if appropriate) despite the person and/or their carer carefully trying to manage their diabetes”.
  

Insulin pump therapy was also recommended as a possible treatment for children under 12 years with type 1 diabetes “…if treatment with multiple daily injections is not practical or is not considered appropriate”. The guidance recommends that children who use insulin pump therapy should undergo a trial of multiple daily injections between the age of 12 and 18 years (NICE 2009).

6.4.3.2 New Zealand

The New Zealand Society for the Study of Diabetes (NZSSD) Position Statement on Insulin Pump Therapy (2008), is based on the results of a systematic review and economic evaluation of insulin pump therapy in the New Zealand setting, which concluded that the improvements in glycaemic control with insulin pump therapy are of “…a small magnitude and of borderline statistical significance” (Campbell 2008).

It is recommended that insulin pump therapy should be available to people with type 1 diabetes “…who, despite optimal high level care and MDI [multiple daily injections] using a long-acting analogue, meet the following criteria:

• 
  Recurrent severe unexplained hypoglycaemic episodes (2 or more in a 12 month period);
  
• 
  Women who have suboptimal glycaemic control and wanting to conceive;
  
• 
  Children (<12 years) in whom MDI is judged to be impractical;
  
• 
  Poor glycaemic control (HbA_1c >8.5%) demonstrated by CGM [continuous glucose monitoring] due to a prominent dawn phenomenon; and
  
• 
  Other selected situations: gastroparesis, eating disorders” (NZSSD 2008).
  

6.4.3.3 Scotland

The Scottish Intercollegiate Guidelines Network (SIGN) state that “CSII [insulin pump] therapy is associated with modest improvements in glycaemic control and should be considered for patients unable to achieve their glycaemic targets (Grade A)” and “CSII [insulin pump] therapy should be considered in patients who experience recurring episodes of severe hypoglycaemia (Grade B)” (SIGN 2010).

6.4.3.4 United States

Two American professional organisations provide recommendations for insulin pump management. The Statement by the American Association of Clinical Endocrinologists consensus panel on insulin pump management provides expert advice on patient selection and the education and training of health professionals caring for patients with insulin pumps (Grunberger 2010). This statement provides the US Centre for Medicare and Medicaid Services Insulin Pump Patient Eligibility Criteria, which are:

“(a) Patient has completed a comprehensive diabetes education program and has been receiving multiple daily injection insulin with frequent self-adjustments for at least 6 months before pump initiation. Patient has documented self-monitoring of blood glucose frequency an average of ≥ 4 times per day during the previous 2 months. Patient must also meet ≥1 of the following criteria:

• 
  HbA1c > 7.0%
  
• 
  history of recurrent hypoglycaemia
  
• 
  wide fluctuations in blood glucose before mealtime
  
• 
  dawn phenomenon with fasting plasma glucose concentration frequently >200 mg/dL or history of severe glycaemic excursions
  

(b) Patient on pump therapy before enrolment and has documented self-monitored blood glucose an average of ≥4 times per day during the month before enrolment” (Grunberger 2010).

The Insulin Pump Therapy: Guidelines for Successful Outcomes provides consensus-based advice on appropriate candidates for pump therapy and guidance on associated self-management education (American Association of Diabetes Educators (AADE) 2008). This guideline states that patients should be considered for insulin pump therapy when they are not meeting treatment goals with multiple daily injections, including:

• 
  HbA_1c >7.0-7.5% with frequent severe hypoglycaemia (<55 mg/dL);
  
• 
  hypoglycaemic events requiring third-party assistance or interfering with work, school or family obligations;
  
• 
  frequent, unpredictable fluctuations in blood glucose levels; or
  
• 
  patient perception that diabetes management is impeding the pursuit of personal or professional goals (AADE 2008).