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Are Systematic Reviews and Meta-Analyses Appropriate Tools for Assessing Evolving Medical Device Technologies?
David Price1, Claudia Graham1, Christopher G Parkin2
1Dexcom, Inc, San Diego, CA, USA.
Journal of Diabetes Science and Technology
|October 1, 2015
Summary
Systematic reviews may underestimate real-time continuous glucose monitoring (RT-CGM) benefits due to device evolution and behavioral factors. These limitations challenge coverage and reimbursement for diabetes technology.
Area of Science:
- Endocrinology
- Medical Technology Assessment
Background:
- Systematic reviews and meta-analyses (SRMAs) are used for comparative effectiveness of diabetes treatments.
- SRMAs may be unsuitable for rapidly evolving technologies like real-time continuous glucose monitoring (RT-CGM) due to device advancements and behavioral components.
Purpose of the Study:
- To review limitations of SRMAs in assessing RT-CGM value.
- To highlight how SRMA conclusions may underestimate RT-CGM's glycemic benefits.
Main Methods:
- Focused review on limitations of a specific Cochrane Collaboration report on CGM.
- Analysis of 12 studies assessing RT-CGM in adults and children.
Main Results:
- SRMAs struggle to differentiate between past and current RT-CGM device generations.
- Inadequate reporting on user training and data utilization for therapy adjustment in many studies.
- Overreliance on intention-to-treat analyses neglects crucial behavioral components like frequency and duration of RT-CGM use.
Conclusions:
- SRMA generalizability is limited for RT-CGM due to methodological constraints.
- SRMA findings may underestimate the true glycemic benefits of current and future RT-CGM devices.
- Limitations pose challenges for technology coverage and reimbursement decisions.
