Table A3:

GRADE Evidence Profile for Comparison of Flash Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Managing Type 1 Diabetes

Number of Studies (Design)	Risk of Bias	Inconsistency	Indirectness	Imprecision	Publication Bias	Upgrade Considerations	Quality
Glucose variability
1 (RCT, adults)32	No serious limitations	Unknown	Serious limitations (−1)a	No serious limitations	Undetected	None	⊕⊕⊕ Moderate
Time in target glucose range (3.9–10.0 mmol/L [70–180 mg/dL]) in 24 hours
1 (RCT, adults)32	No serious limitations	Unknown	Serious limitations (−1)b	No serious limitations	Undetected	None	⊕⊕⊕ Moderate
Time above the target glucose range (> 13.3 mmol/L [70 mg/dL]) in 24 hours
1 (RCT, adults)32	No serious limitations	Unknown	Serious limitations (−1)b	No serious limitations	Undetected	None	⊕⊕⊕ Moderate
Time in hypoglycemia (< 3.9 mmol/L [70 mg/dL] within 24 hours)
1 (RCT, adults)32	Serious limitations (−1)c	Unknown	No serious limitations	No serious limitations	Undetected	None	⊕⊕⊕ Moderate
Time in hypoglycemia (< 3.9 mmol/L [70 mg/dL] at night [11 pm-6 am] within 7 hours)
1 (RCT, adults)32	Serious limitations (−1)c	Unknown	No serious limitations	No serious limitations	Undetected	None	⊕⊕⊕ Moderate
Hypoglycemia events (<3.9 mmol/L (70mg/dL) within 24 hours
1 (RCT, adults)32	No serious limitations	Unknown	Serious limitations (−1)b	No serious limitations	Undetected	None	⊕⊕⊕ Moderate
Quality of life
1 (observational, adolescents)47,48	Serious limitations (−1)d	Serious limitations (−1)f	No serious limitations	No serious limitations	Undetected	None	⊕ Very low
1 (RCT, adults)32	Very serious limitations (−2)e		No serious limitations	No serious limitations	Undetected	None
Fear of hypoglycemia
1 (observational, adolescents)47	Serious limitations (−1)g	No serious limitations	No serious limitations	No serious limitations	Undetected	None	⊕⊕⊕ Moderatel
1 (RCT, adults)32	No serious limitations		Serious limitations (−1)h	No serious limitations	Undetected	None
Glycated hemoglobin levels
1 (RCT, adults)32	No serious limitations	Serious limitations (−1)g	Very serious limitations (−2)i	No serious limitations	Undetected	None	⊕ Very lowl
2 (observational, adolescents, adults)47,50	Serious limitations1)d		No serious limitations	Serious limitations1)j	Undetected	None
Severe hypoglycemia events
1 (observational, adults)50	No serious limitations	Unknown	No serious limitations	Serious limitations (−1)k	Undetected	None	⊕ Very lowl
1 (RCT, adults)32	No serious limitations		Serious limitations (−1)m	Very serious limitations (−2)k	Undetected	None
Device-related adverse events
1 (RCT, adults)32	No serious limitations	Unknown	Serious limitations (−1)n	Very serious limitations (−2)k	Undetected	None	⊕ Very low

Abbreviations: GRADE, Grading of Recommendations Assessment, Development, and Evaluation; RCT, randomized controlled trial.

^aResults for standard deviation and coefficient of variation are reported as statistically significant, but standard deviation and coefficient of variation at the end of follow-up for both flash glucose monitoring and self-monitoring of blood glucose is larger than the maximum recommended clinical threshold.

^bUncertainty if the difference is large enough to affect hard clinical outcomes.

^cImputed data using the last observation carried forward.

^dDuration of self-monitoring of blood glucose in AI Hayek et al⁴³ was not given. Potential for bias if effectiveness depends on duration of device use.

^eOnly per-protocol results were shown. Unclear why intent-to-treat results were not reported or why some participants did not adhere to protocol.

^fInconsistency in findings across all three studies.

^gInconsistency in findings across studies.

^hCertain populations that are likely to fear hypoglycemia (e.g., those with hypoglycemia unawareness) were excluded.

ⁱNull glycated hemoglobin results were desirable, but we wanted to assess situations where null results are undesirable.

^jLarge confidence intervals covering effect sizes that are consistent with null effects, favouring flash glucose monitoring, and favouring self-monitoring of blood glucose.

^kVery small number of events.

^lConclusion on the certainty of evidence is based on the best quality study.

^mCertain populations that are likely to have severe hypoglycemia (e.g., those with hypoglycemia unawareness) were excluded.

ⁿA very small information size makes it difficult to generalize results beyond the sample in the study.