. 2019 Dec 12;19(8):1–108.

Table A4:

GRADE Evidence Profile for Comparison of Flash Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Managing Type 2 Diabetes

Number of Studies (Design)	Risk of Bias	Inconsistency	Indirectness	Imprecision	Publication Bias	Upgrade Considerations	Quality
Glucose variability
1 (RCT, adults)³³	No serious limitations	Very serious limitations (−2)^a	No serious limitations	No serious limitations	Undetected	None	⊕⊕ Low
Time in target glucose range (3.9–10.0 mmol/L [70–180 mg/dL]) in hours, within 24 hours
1 (RCT, adults)³³	No serious limitations	Unknown	No serious limitations	Very serious limitations (−2)^b	Undetected	None	⊕⊕ Low
Time above target glucose range (> 13.3 mmol/L) in hours, within 24 hours
1 (RCT, adults)³³	No serious limitations	Unknown	No serious limitations	Very serious limitations (−2)^b	Undetected	None	⊕ Low
Time in hypoglycemia (< 3.9 mmol/L [70 mg/dL] within 24 hours)
1 (RCT, adults)³³	No serious limitations	Unknown	Serious limitations (−1)^c	No serious limitations	Undetected	None	⊕⊕⊕ Moderate
Time in hypoglycemia (< 3.9 mmol/L [70 mg/dL] at night [2300–0600h] within 7 hours)
1 (RCT, adults)³³	No serious limitations	Unknown	Serious limitations (−1)^c	No serious limitations	Undetected	None	⊕⊕⊕ Moderate
Hypoglycemia events (< 3.9 mmol/L [70 mg/dL] within 24 hours)
1 (RCT, adults)³³	No serious limitations	Unknown	Serious limitations (−1)^c	No serious limitations	Undetected	None	⊕⊕⊕ Moderate
Severe hypoglycemia events
1 (RCT, adults)³³	No serious limitations	Unknown	Serious limitations (−1)^c	Very serious limitations (−2)^d	Undetected	None	⊕ Very low
Quality of life
1 (RCT, adults)³³	No serious limitations	No serious limitations	Very serious limitations (−2)^j	No serious limitations	Undetected	None	⊕⊕ Low^h
1 (observational, adults)⁴⁸	Serious limitations (−1)^e		No serious limitations	No serious limitations	Undetected	None
Glycated hemoglobin levels
1 (RCT, adults)³³	Serious limitations (−1)^f	No serious limitations	Serious limitations (−1)^g	No serious limitations	Undetected	None	⊕⊕ Low
Device-related adverse events
1 (RCT, adults)³³	No serious limitations	Unknown	Serious limitations (−1)ⁱ	Very serious limitations (−2)^d	Undetected	None	⊕ Very low

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

Inconsistency across several scales of glucose variability.

Confidence intervals are too wide, covering values that are consistent with null, in favour of flash glucose monitoring, and in favour of self-monitoring of blood glucose.

Uncertainty on whether the difference is big enough to affect clinical outcomes.

Data too sparse. No meaningful comparative safety inference can be made.

Duration of study not given. Potential for bias if length of follow-up differs.

Data imputed using the last observation carried forward.

Generalizability depends on the age distribution of target population.

Conclusion on certainty of evidence is based on the better-quality study.

ⁱ

Sample size for assessing outcome is too small. Findings might not reflect target population.

Some questions in the survey do not seem to relate to use of flash glucose monitoring or self-monitoring of blood glucose.