Table 9: GRADE Quality Assessment of Studies.
No. of Studies | Design | Quality/Limitations | Indirectness | Inconsistency | Publication Bias | Results | Quality |
Pump and CGM Versus Pump and SMBG | |||||||
2 | RCTs | Compliance issue in Raccah et al. - 35% patients in CGM group failed to wear the sensors ≥% of the time. | No serious inconsistency | No serious inconsistency | Unlikely |
Raccah et al. ΔHbA1c |
Moderate |
Raccah N=132 6 months |
Possible, but not considered sufficient to downgrade quality of evidence. | CGM (-0.81%) vs. SMBG (-0.57%) P=0.087 Δ Hypoglycemia CGM 0.1±0.9 vs. SMBG 0.1±0.7 episodes per day, P=NS |
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Hirsch N=146 6 months |
Both studies - no details about changes in patient self management (CMG patients may engage in more lifestyle modifications by being able to see real time glucose trend information) | ||||||
High | Hirsch et al. ΔHbA1c | ||||||
Allocation not reported in both studies. | CGM Mean(SD) -0.56 (0.72) SMBG Mean(SD) -0.71(0.71), P=0.37 | ||||||
No sample size calculation in Hirsch et al. Possible Type 2 error. | Hypoglycemia Incidence # events between CGM and SMBG, P = 0.07 | ||||||
Severe Hypoglycemia 14 events total, 11 in CGM within 8 patients, P=0.04 | |||||||
High → Moderate | |||||||
BUT: 6 events patient not wearing device. In 5 remaining instances, patients ignored alerts or based treatment decision on sensor only. |
CGM, continuous glucose monitor; RCT, randomized controlled trial; SMBG, self monitoring blood glucose;