The Application of Continuous Glucose Monitoring Endpoints in Clinical Research: Analysis of Trends and Review of Challenges
Authors' conclusion
Our data provide evidence of significant increases in the application of CGM endpoints in clinical studies in the last six years, including studies with TIR as the PE. Increases have been driven largely by academia, but our data show that industry is starting to follow suit. The significant increase in studies that included pediatrics is encouraging.
Study context
- Population
- Clinicaltrials.gov studies of drugs, devices and combination products containing continuous glucose monitoring (CGM) terms, posted 2012 to 2023
- Participants
- 315 studies
- Comparison
- P2 vs P1
- P2n = 194
- P1n = 121reference
- Outcome
- Trends in CGM endpoint adoption
Methodological detailsclinicaltrials.gov, descriptive statistics, two-tailed t tests, two periods compared (P1 2012-2017 vs P2 2018-2023), Clinicaltrials.gov searched for CGM studies posted 2012–2023; 1269 returned, 954 excluded
- clinicaltrials.gov
- Descriptive statistics
- Two-tailed t tests
- Two periods compared (P1 2012-2017 vs P2 2018-2023)
- Clinicaltrials.gov searched for CGM studies posted 2012–2023; 1269 returned, 954 excluded
Main finding
As reported in the abstract
Trends in clinical studies with CGM terms
P1
121
events
P2
194
events
- Significant increase in total clinical studies, P1 to P2
- 60.3%
- Significant increase in Phase 2 studies in P2
- 125.8
- Significant increase in Phase 3 studies in P2
- 169.2%
- Increase in adult-only studies (predominated in both periods) in P2
- 40.4%
- Significant increase in nonindustry-funded studies (most studies) in P2
- 80.0%
- Significant increase in industry-only funded studies in P2
- 78.4%
- Increase in T1D studies, not statistically significant
- 55.8%
- Increase in T2D studies, not statistically significant
- 26.9%
- Significant increase in studies of nondiabetes-related indications
- 233.3%
- Studies using CGM-derived metrics as primary endpoints
- 27.6%
- Significant increase in studies using time in range (TIR) in P2
- 222.4%
- Significant decrease in studies using mean amplitude of glycemic excursions (MAGE)
- 71.3%
Original publication
The Application of Continuous Glucose Monitoring Endpoints in Clinical Research: Analysis of Trends and Review of Challenges. J Diabetes Sci Technol. Published 28 November 2024. doi:10.
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