Using Continuous Glucose Monitoring Values for Bolus Size Calculation in Smart Multiple Daily Injection Systems: No Negative Impact on Post-bolus Glycemic Outcomes Found in Real-World Data
Authors' conclusion
We found no differences in four-hour post-bolus glycemic outcomes when using CGM or BG except for time below range, which showed evidence of being lower for CGM. Though preliminary, our results confirm prior findings showing non-inferiority of using CGM values for bolus calculation compared with BG usage in the real world.
Study context
- Population
- Users of a smart MDI device with a continuous glucose monitoring (CGM) system; 18 months, 79,000 bolus observations79,000 boluses
- Participants
- 184 users
- Exposure
- Bolus calculation using CGM values vs blood glucose (BG) values
- Outcome
- Post-bolus glycemic outcomes
- Follow-up
- 4 hours post-bolus
Methodological detailsnon-inferiority hypothesis, logistic regression, mixed model regression accounting for within-subject correlations
- Non-inferiority hypothesis
- Logistic regression
- Mixed model regression accounting for within-subject correlations
Main finding
As reported in the abstract
4 hours
- No differences between CGM- and BG-based boluses (initial logistic regression)
- P > .183
- Confirmed by mixed model regression in all cases except time below range
- P > .199
Observational data: associations, not effects.
Further findings
Time below range (odds of CGM-based bolus calculation) · 4 hours
- Higher time below 70 mg/dL predicted lower odds of CGM-based bolus calculation
- OR = 0.987, P < .0001
- Higher time below 54 mg/dL predicted lower odds of CGM-based bolus calculation
- OR = 0.987, P = .0276
- Mixed model regression
Original publication
Using Continuous Glucose Monitoring Values for Bolus Size Calculation in Smart Multiple Daily Injection Systems: No Negative Impact on Post-bolus Glycemic Outcomes Found in Real-World Data. J Diabetes Sci Technol. Published 24 September 2023. doi:10.
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