The author of this report is the Croatian Agency for Quality and Accreditation in Health Care and Social Welfare (AAZ), with the co-authors being the Norwegian Institute of Public Health (NIPHNO) and the Main Association of Austrian Social Security Institutions (HVB).
The authors addressed the following research question: whether the use of real-time continuous glucose monitoring (rtCGM) and flash glucose monitoring (FGM) medical devices as personal, standalone systems, being adjunctive (cannot be used to make treatment decision without confirmatory finger-stick testing) or non-adjunctive (can be used to make treatment decision without confirmatory finger-stick testing) in patients with diabetes mellitus type 1 and type 2 (T1DM and T2DM) in adults and children, gestational DM patients using insulin, either through insulin pump therapy (CSII) or multiple daily insulin injections (MDII), is more effective and/or safer than using self-monitoring blood glucose (SMBG) medical devices.
The selection of assessment elements was based on the EUnetHTA Core Model® Application for Rapid Relative Effectiveness (REA) Assessments. A new systematic review (SR) of RCTs with a meta-analysis on one clinical outcome (HbA1C change) was performed. Study, outcomes validity and level of evidence were assessed following the EUnetHTA guidelines. The Cochrane Risk of Bias Tool was used both on study and outcome levels, and GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) tool was used to assess the certainty of the body of evidence were used.
Twelve (12) RCTs reported on the use of rtCGM (as standalone devices or with insulin pumps) and FGM devices compared with SMBG. Only one head-to-head trial was identified comparing rtCGM and FGM. Three nRCTs were included in the safety domain in addition to those RCTs included in the clinical effectiveness domain.
Conclusion
The use of CGM devices assessed was associated with a reduction in HbA1c in the majority of the studies that included MDII treated patients and in the two studies with MDII and CSII treated patients; both CGM and FGM devices assessed were associated with reduction in hypo- and hyperglycaemia outcomes and improved treatment satisfaction in patients with T1 or T2DM, compared with SMBG. No RCTs were found investigating devices assessed with CE mark authorization in pregnancy. Further high-quality head-to-head studies are needed on long-term relative effectiveness and safety comparing CGM and FGM devices, especially in children and pregnancy. Adults, children, and parents with T1 DM reported very positive experiences with CGM and FGM devices; different benefits were shown as well as the most critical barriers – high cost and unavailability of these medical devices in some countries.
See the full report in English here.
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