Health technology assessment of continuous glucose monitors (CGMs) and continuous subcutaneous insulin infusion (CSIIs)

Abstract

The emergence of diabetes technologies for glucose monitoring and insulin administration has significantly reshaped the management of type 1 diabetes (T1D). People with diabetes are increasingly choosing to use technologies such as real time continuous glucose monitors (rtCGM), intermittently scanned continuous glucose monitors (isCGM), continuous subcutaneous insulin infusion (CSII), sensor-augmented pumps (SAP), and hybrid closed-loop (HCL) systems to replace the standard care of self-monitoring of blood glucose (SMBG) and multiple daily injections (MDI). This thesis systematically evaluates the clinical effectiveness, cost-effectiveness, and psychosocial impact of diabetes technologies in individuals with T1D. The goal is to provide an integrated overview of outcomes such as HbA1c, time-in-range (TIR), treatment satisfaction, and cost-effectiveness. A systematic literature review was conducted of clinical, cost-effectiveness, and patient reported outcomes (PRO) evidence. 63 studies were identified as clinical evidence, 48 as cost-effectiveness evidence, and 20 as PRO or psychosocial evidence across the different technologies. A survey was conducted to complement the findings of the systematic literature review and to collect data directly from adults living with T1D. The survey included various questions covering clinical outcomes, perceived benefits and burdens, device satisfaction, financial cost, and burden of the technologies used by participants. An investigation separate from the systematic review was conducted on the effect of exercise on glycaemic control through integration within the survey and a brief literature search. SAP technology demonstrated the greatest improvements in glycaemic outcomes, with average HbA1c reduction of 0.83 %, followed by HCL systems with average HbA1c reduction of 0.79 %. Although this could be attributes to SAP technology comparators (SMBG + MDI) being less intensive than HCL comparators (CGM + MDI/CSII). The biggest technology effects were observed in populations with high HbA1c baseline and high risk of hypoglycaemia. In terms of economic evaluations, HCL vs isCGM showed the highest quality adjusted life years (QALYs) gain at 2.2 ±0.3, with an average incremental cost-effectiveness ratio (ICER) of € 28,886 per QALY. Cost-effectiveness of all technologies was most evident in cohorts with poor glycaemic control in settings using societal perspectives. Furthermore, psychosocial evidence highlighted improved treatment satisfaction, reduced diabetes distress, and better perceived control with technology use. Survey participants (n=23) were grouped into 3 cohorts: CGM + CSII, CGM + MDI, and SMBG+MDI. The best glycaemic control was noted within the CGM + CSII cohort with 79 % of the cohort achieving HbA1c <7 %, while 50 % of CGM + SMBG cohort achieving HbA1c <7 %. Device satisfaction was high across cohorts. HbA1c and TIR had a moderate negative correlation. Overall, the survey results aligned with the systematic literature review results. The evidence supports the clinical and economic value of diabetes technologies, particularly SAP and HCL systems, in T1D management. Cost-effectiveness is favourable in most health system settings across countries. Broad adoption of these technologies, aligned with patient needs and health system capacities, has the potential to improve long-term outcomes for people with T1D.