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Table 1 Summary of the main findings from the published studies

From: Economic evaluation of continuous subcutaneous insulin infusion for children with diabetes - a pilot study: CSII application for children – economic evaluation

Authors

Objective

Methodology

Results

Conclusions

Plotnick et al. [8]

To evaluate the safety and effectiveness of insulin pump therapy in children and adolescents with type-1diabetes.

All patients who started insulin pump therapy between 1 January 1990 and 31 December 2000 were included in this study. Medical records were reviewed for 95 patients, ages 4–18 years at pump start. The mean (SD) age was 12.0-3.1 years, and children under the age of 10 years comprised 29% of the group. Patients and families chose insulin pump therapy for several reasons, including better control, less blood glucose variability, fewer injections and improvement in lifestyle flexibility. HbA1c was measured at each visit by cation-exchange high-performance liquid chromatography.

There was a small but significant decrease in HbA1c at 3–6 months after starting with pump (7.7 vs. 7.5%; P < 0.03). HbA1c levels then gradually increased and remained elevated after 1 year of follow- up. This association was confounded by age and diabetes duration, both of which were associated with higher HbA1c levels. After adjusting for duration and age, mean HbA1c after pump start was significantly lower than before pump start (7.7 vs. 8.1%; P <0.001). There were fewer hypoglycemic events after pump start (12 vs. 17, rate ratio 0.46, 95% CI 0.21–1.01).

Insulin pump use was safe and effective.

After adjusting for age and duration of diabetes, HbA1c was in fact lower after pump placement.

Both monitoring frequency and parental involvement were significantly associated with lower HbA1c levels.

Bode et. al. [9]

To compare multiple daily injections (MDI), and CSII and to assess the effects on quality of life.

Comparative analysis

In adults and adolescents with type-1diabetes, CSII has been shown to lower HbA1c levels, reduce the frequency of severe hypoglycemia and limit excessive weight gain versus MDI without increasing the risk of diabetic ketoacidosis. The effectiveness of CSII and improvements in pump technology have fueled a dramatic increase in the use of this therapy.

Insulin pump or continuous subcutaneous insulin infusion (CSII) therapy provides a treatment option that can dramatically aid in achieving all of these goals.

Wilson et al. [10]

To compare continuous subcutaneous insulin infusion (CSII), and continuing multiple daily injections (MDIs), in respect to their safety in young children, glycemic control, hypoglycemia and quality of life.

A randomized 1-year feasibility trial comparing CSII with continuing MDIs in preschool children with a history of type-1diabetes for at least 6 months’ duration. Prospective outcomes included measures of overall glycemic control (HbA1c and continuous glucose monitoring system), the incidence of severe hypoglycemia and diabetic ketoacidosis, the percent of glucose values below 3.9 mmol/l, and the parents’ report of quality of life.

The 19 subjects’ ages ranged from 1.7 to 6.1 (mean 3.6) years, duration of diabetes ranged from 0.6 to 2.6 (mean 1.4) years, and baseline HbA1c ranged from 6.7 to 9.6% (mean 7.9%). Nine subjects were randomized to start CSII and 10 to continue on MDI. Overall metabolic control, diabetes quality of life, and the incidence of hypoglycemia were similar in the two groups. No subject had diabetic ketoacidosis, while one subject in each group had an episode of severe hypoglycemia. No CSII subject discontinued using the pump during or after the study.

CSII can be a safe and effective method to deliver insulin in young children.

Cohen et al. [2]

To project long-term costs and outcomes of CSII compared with MDI in adult and adolescent T1DM.

The study modelled analysis utilizing a lifetime horizon in adult and adolescent specialty-care type-1-diabetes patient populations from Australia. Published diabetes complication costs, treatment costs and discount rates of 5.0% per annum were applied to costs and clinical outcomes. A lifetime horizon was used, considering only direct medical costs and excluding indirect and non-medical costs. The validated CORE diabetes model employs standard Markov/Monte Carlo simulation techniques.

Mean direct lifetime outcomes were $A 34 642 higher with CSII treatment than with MDI for adult patients and $A 41 779 for adolescent patients. Treatment with CSII is associated with an improvement in life expectancy of 0.393 years for adults compared with MDI and 0.537 years for adolescents. The corresponding gains in QALYs were 0.467 QALYs and 0.560 QALYs for adults and adolescents, respectively. This produced incremental cost effectiveness ratios (ICERs) of $A88 220 and $A 77851 per life-year gained for CSII compared with MDI for adult and adolescent T1DM.

The analysis suggests that CSII is associated with ICERs in the range of $A53 022–259 646 per QALY gained with most ICERs representing a significant savings in Australia under the majority of scenarios explored.