Outcome | No of studies (No of paired values) | Study design | Factors that may decrease certainty of evidence | Effect per 1000 patients tested | Test accuracy CoE | ||||
Risk of bias | Indirectness | Inconsistency | Imprecision | Publication bias | Pre-test probability of 30% | ||||
(A) Should CGM devices be used to diagnose hypoglycaemia in preterm infants? | |||||||||
Sensitivity | 0.39 (95% CI 0.12 to 0.74) | Prevalence | 30% | ||||||
Specificity | 0.99 (95% CI 0.99 to 1.00) | ||||||||
True positives (patients with hypoglycaemia) | 5 studies (1706 paired values) | Cross-sectional (cohort type accuracy study) | Serious* | Not serious | Not serious | Serious† | None | 117 (36 to 222) | ⨁⨁◯◯ LOW |
False negatives (patients incorrectly classified as not having hypoglycaemia) | 183 (78 to 264) | ||||||||
True negatives (patients without hypoglycaemia) | 5 studies (1706 paired values) | Cross-sectional (cohort type accuracy study) | Serious* | Not serious | Not serious | Not serious | None | 693 (693 to 700) | ⨁⨁⨁◯ MODERATE |
False positives (patients incorrectly classified as having hypoglycaemia) | 7 (0 to 7) | ||||||||
(B) Should CGM be used to diagnose hyperglycaemia in preterm infants? | |||||||||
Sensitivity | 0.87 (95% CI 0.81 to 0.92) | Prevalence | 0.19 | ||||||
Specificity | 0.99 (95% CI 0.99 to 0.99) | ||||||||
True positives (patients with hyperglycaemia) | 2 studies (1339 paired values) | Cross-sectional (cohort type accuracy study) | Serious* | Not serious | Not serious | Not serious | None | 165 (154 to 175) | ⨁⨁⨁◯ MODERATE |
False negatives (patients incorrectly classified as not having hyperglycaemia) | 25 (15 to 36) | ||||||||
True negatives (patients without hyperglycaemia) | 2 studies (1339 paired values) | Cross-sectional (cohort type accuracy study) | Serious* | Not serious | Not serious | Not serious | None | 802 (802 to 802) | ⨁⨁⨁◯ MODERATE |
False positives (patients incorrectly classified as having hyperglycaemia) | 8 (8 to 8) |
*Several studies used a PoC device as their reference standard which has been deemed as too inaccurate for use in neonates.
†One study has a very wide CI.
CGM, continuous glucose monitoring; PoC, point of care.