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

Appendix D – National and international guidelines for the management of type 1 diabetes using insulin pump therapy

Reference	Recommendation	Difference
(Craig 2011) Australia – NHMRC Recommended	Nonsensor-augmented CSII should be considered for use in individuals in whom the expected magnitude of benefit is clinically significant in terms of reducing HbA1c, reducing hypoglycaemia or improving quality of life Practice points: Individuals who may be likely to benefit from CSII 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, individuals exhibiting desirable CSII 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 self-management skills (in adults), are reliable in follow-up health care
Victorian CSII working party guidelines Australia	Clinical recommendations: Patient confirmed as having Type I diabetes or diabetes in pregnancy. (For Type 1 diabetes this may include measurement of fasting C-peptide and (pre-exogenous insulin) insulin levels and anti-islet antibodies, including anti-GAD and anti-IA2 antibodies) Lifestyle allows for wearing of a pump Lifestyle choices to facilitate adequate time for initial stabilization and education Patient requires less than 300 Units of (100 IU) insulin per 2-3 days Consistent home blood glucose (BG) monitoring and recording or is willing to increase monitoring (and subsequently demonstrates has done so) Ability to measure blood or urine ketone levels, or agreeable to learning to do so Basic numeracy Willing and able to learn how to carbohydrate count and to calculate doses of insulin Willing to communicate on a regular basis with the team Able to comply with treatment plans or scheduled visits Absence of any severe or unstable psychiatric condition: eating disorder, psychosis, depression. It is noted that the presence of an eating disorder or depression does not preclude insulin pump use Reasonable level of motivation and able to accept responsibility for care of diabetes No significant visual impairment No major restriction in manual dexterity, or lack of required assistance Adequate condition of subcutaneous tissue and skin Satisfactory hygiene Funds available to purchase pump and consumables (N.B. NDSS will not provide consumables for non-pregnant Type 2 diabetes patients using CSII therapy)	Details more specific clinical requirements to Craig 2011, as well as financial suitability.
(Scottish Intercollegiate Guidelines Network (SIGN) 2010) Scotland	CSII therapy is associated with modest improvements in glycaemic control and should be considered for patients unable to achieve their glycaemic targets (Grade A) CSII therapy should be considered in patients who experience recurring episodes of severe hypoglycaemia (Grade B)
(National Institute for Health and Clinical Excellence 2008) England Wales	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 A1c (HbA1c) levels with multiple insulin injections result in the person having ‘disabling hypoglycaemia', or - HbA1c 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 is recommended as a possible treatment for children under 12 years with type 1 diabetes mellitus if treatment with multiple insulin injections is not practical or is not considered appropriate. Children who use insulin pump therapy should have a trial of multiple insulin injections when they are between the age of 12 and 18 years. - It is recommended that CSII therapy be initiated only by a trained specialist team, which should normally comprise a physician with a specialist interest in insulin pump therapy, a diabetes specialist nurse and a dietitian. Specialist teams should provide structured education programmes and advice on diet, lifestyle and exercise appropriate for people using CSII. - Following initiation in adults and children 12 years and older, CSII therapy should only be continued if it results in a sustained improvement in glycaemic control, evidenced by a fall in HbA1c levels, or a sustained decrease in the rate of hypoglycaemic episodes. Appropriate targets for such improvements should be set by the responsible physician, in discussion with the person receiving the treatment or their carer. - CSII therapy is not recommended for the treatment of people with type 2 diabetes mellitus.
(American Association of Diabetes Educators 2008) United States	Patients should be considered for insulin pump therapy when intermittent insulin injections are not meeting treatment goals and outcome measures are suboptimal, including, but not limited to: - A1c > 7.0-7.5%, accompanied by frequent severe hypoglycaemia (< 55 mg / dL) - Hypoglycaemic events requiring third-party assistance or interfering with work, school, or family obligations - Frequent and unpredictable fluctuations in blood glucose levels - Patient perception that diabetes management impedes the pursuit of personal or professional goals
(Grunberger 2010) United States	The statement provides the US Center for Medicare and Medicaid Services Insulin Pump Patient Eligibility Criteria. Patients must meet 1 of the following criteria: (a) Patient has completed a comprehensive diabetes education programme 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 a pump therapy before enrolment and has documented self-monitored blood glucose an average of ≥ 4 times per day during he month b f re enrolment.
The New Zealand Society for the Study of Diabetes (NSSD). NSSD Position Statement on Insulin Pump Therapy, June 2008: New Zealand	The NZSSD Executive states that Insulin Pump Therapy should be available to people with Type 1 Diabetes who, despite optimal high-level care and MDI using a long acting analogue, meet the following criteria: Recurrent severe (2) unexplained hypoglycaemic episodes (2 or more in a 12 month period); Women who have suboptimal glycaemic control and wanting to conceive; Children less 12 years, in whom MDI is judged to be impractical; Poor glycaemic control (HbA1c greater than 8.5% demonstrated by CGM to be due to a prominent dawn phenomenon; and Other selected situations: gastroparesis, eating disorders. Practice Guidelines: The person should be assessed by a physician experienced in insulin pump therapy and would include evidence of adherence to appropriate nutritional and self-monitoring practices; Pump therapy should be administered through the special authority mechanism or equivalent criteria-based methodology A national panel should be developed to assess applications; Pump therapy should only be commenced and supervised by a diabetic service that has the appropriate experience and resources to manage insulin pump therapy; Access to treatment should be consistent throughout New Zealand; Funding should apply to the pump and consumables; and Response to treatment (according to predefined outcomes) should be demonstrated annually to be eligible for ongoing funding.
Agence d’evaluation des technologies et des modes d’intervention en santé (AETMIS) 2005 Canada - Quebec	1 As set out in the Canadian practice guidelines, the preferred therapeutic approach to type 1 diabetes, in both adults and children, be based on intensive therapy with multiple daily insulin injections; 2 Therapy by continuous subcutaneous insulin infusion (insulin pump) be recognised in Quebec as a treatment modality that might be indicated for a limited, select group of people with type 1 diabetes (various selection criteria based on expert opinion are cited in this report); 3 The Minister consider setting up a multidisciplinary taskforce (including Diabete Quebec, and the clinical and research communities) charged with: • Identifying consensus criteria for patient selection and for prescribing and monitoring of insulin pump therapy; • Designating clinics that would participate in the implementation of pump therapy and determining the composition and role of the professional team required; • Developing common candidate selection, patient education and follow- up tools; • Monitoring and implementation of pump therapy; and • Re-evaluating the use of pump therapy in Quebec sometime after it is introduced. 4 The consensual criteria for the use of insulin pumps to be reviewed periodically in the light of new evidence that becomes available after this report, in particular , from studies comparing the insulin pump and multiple injection therapy with glargine, it may soon be available in Canada (technology watch); 5 A clear consistent policy governing the use of the insulin pump be developed and made part of a broader initiative for managing diabetes in Quebec that would take into account the need to increase the ability of Quebec’s health-care system to offer intensive therapy to all people with type 1 diabetes; 6 Two options for standardising the prescription and coverage of modalities be examined: • Consider the [insulin] pump an exceptional treatment modality for exceptional patients, with access granted by the Regie de l’assurance maladie du Quebec (RAMQ) on a case by case basis according to the criteria established by the above mentioned taskforce and/or on request by a physician; • Institute systematic pump prescription and utilisation auditing and monitoring procedures based on set criteria in collaboration with the clinical settings concerned, possibly by creating a registry of pump-treated patients or developing tools for selecting cases on a priority basis within a predetermined budget allowance; 7 A full range of technical service be provided in French in Quebec by the manufacturers and distributors of insulin pumps; and 8 Research on patient selection criteria and cost-effectiveness of insulin pumps in the Quebec context be considered an important avenue of investigation by Fonds de la recherché en santé du Quebec (FRSQ).

Appendix E – Current Guidelines hosted by the NHMRC Clinical Guidelines Portal that reference insulin pumps as at January 2015

Reference	Recommendations in relation to insulin pump use in type 1 diabetes
Barclay A, Gilbertson H, Marsh K & Smart C (2010), ‘Dietary management in diabetes’, Australian Family Physician, Vol. 39, No. 8, pp. 579-583.	With regard to insulin pump therapy, notes that: insulin pump therapy provides the greatest flexibility in meal quantity and timing, making it ideal for toddlers and teenagers bolus type and dose can be adjusted to match the meal composition knowledge of carbohydrate counting is essential pre-prandial bolus provides best glycaemic outcomes, but the dose can be split pre-prandial and during the meal for toddlers if eating is erratic the biggest contributor to poor glycaemic outcomes is a missed meal time bolus hypoglycaemia should be treated with short acting carbohydrates.
Craig (2011), ‘National evidence based clinical care guidelines for type 1 diabetes in children, adolescents and adults’, Australian Government Department of Health and Ageing, Canberra.	Evidence statements: “Across all individuals with type 1 diabetes, Level I evidence demonstrates a small but statistically significant reduction in HbA1c with CSII compared to MDI. Level II evidence shows that CSII has a minor benefit for HbA1c levels compared to MDI. There is no evidence to support a reduction in hypoglycaemia in adults. There is Level I evidence of a slight, but statistically significant increase in mild hypoglycaemia in children using CSII. There is no statistically significant evidence to support a reduction in severe and nocturnal hypoglycaemia in adults and children. Level II evidence shows an improvement in QoL with CSII compared to MDI. Level II evidence consistently shows improved treatment satisfaction with CSII compared to MDI.” Note: Level I evidence = A systematic review of Level II studies. Level II studies = randomised controlled trail. Recommendations: “Nonsensor-augmented CSII should be considered for use in individuals in whom the expected magnitude of benefit is clinically significant in terms of reducing HbA1c, reducing hypoglycaemia or improving QoL (Grade C)”. Note: The National Health and Medical Research Council (NHMRC) definition for evidence of Grade C level is that the body of evidence provides some support for the recommendations, but that care should be taken in their application. Practice Points: “Individuals who may be likely to benefit from CSII 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 control and having realistic expectations individuals exhibiting desirable CSII 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 self-management skills (in adults) are able to master the technical skills of CSII are reliable in follow-up health care.” Results of the systematic review: Did not systematically review the effectiveness of insulin pumps and continuous glucose monitoring during pregnancy. Found a mean difference in HbA1c at treatment end of -0.2% (95% CI: -0.28% to -0.12%, P <0.00001) favouring insulin pump therapy over multiple daily injections in all age groups. In adults, the mean difference in HbA1c was -0.16% (95% CI: -0.33% to 0.01, P=0.06) favouring insulin pump therapy, and in children under 18 years the mean difference was significantly lower with insulin pump therapy at 0.25% (95% CI:  0.46% to -0.05%, P=0.01). The majority of identified studies did not show significant differences between insulin pump therapy and multiple daily injections for hypoglycaemic events. However, events rates were low in all studies and the studies were not powered for this outcome, and patients with a history of severe hypoglycaemia were often excluded. There is some advantage to quality of life for patients receiving insulin pump therapy compared to multiple daily injections. The level of education supplied in carbohydrate counting, self-monitoring of blood glucose and bolus correction varied between the treatment arms in some studies. This may explain some of the observed advantages of insulin pump therapy over multiple daily injections. Effective intensive diabetes management regimens require motivation, routine carbohydrate counting, frequent self-monitoring of blood glucose and insulin adjustment, and support from a skilled and well-resourced multidisciplinary team. One study (n=485) which randomised patients to receive either multiple daily injection therapy or sensor-augmented insulin pump therapy found a mean difference in HbA1c of 0.5% (P<0.001) favouring sensor-augmented pump therapy, but no difference in severe hypoglycaemia, although rates were low.
Siafarikas A & O’Connell S (2010), ‘Type 1 diabetes in children - emergency management’, Australian Family Physician, Vol. 39, No. 5, pp. 290-293.	“It is controversial whether subcutaneous (SC) insulin infusion (‘insulin pump therapy’) predisposes patients to an increased risk of DKA. It has been emphasised that this group must carry needles and syringes and an emergency plan with insulin doses in case of pump malfunction”.
The Royal Australian College of General Practitioners and Diabetes Australia (2014), ‘General practice management of type 2 diabetes 2014-15’, Melbourne.	“Insulin pumps have traditionally only been used in the management of type 1 diabetes. There is sparse literature about the benefits of using pumps in people with type 2 diabetes, however, anecdotally, these appear to be advantageous to some people.”

1^ There are currently still seven insulin pumps listed on the February 2014 edition of the Prostheses List. However, the Animas 2020 insulin pump has been discontinued by the manufacturer, but still maintains a listing (Department of Health 2014).

2^ There are seven insulin pumps on the February 2014 edition of the Prostheses List; however, the manufacturer has discontinued the Animas 2020. It has not been delisted at this stage (Department of Health, 2014).

3^ Estimates assume a maximum excess of $500, and no per day hospital co-payment.

4^ The minimum benefit listed on the Prostheses List is the minimum amount payable by insurance companies for an insulin pump under a part C consultation. The amount is agreed between the manufacturers and insurers, mediated by the Department. It is not necessarily the commercial sale price.