Skip to main content
. 2011 Jul 1;11(4):1–29.

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
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;