Table 1.
Select Metrics from Device Pivotal Trials
| Device | Adults or adults/adolescents |
Children |
|
|||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Source | TIR 70–180 mg/dL (%) | Mean SG (mg/dL) | HbA1c (%) | TAR >250 mg/dL (%) | TAR >180 mg/dL (%) | TBR <70 mg/dL (%) | TBR <54 mg/dL (%) | %CV | Source | TIR 70–180 mg/dL (%) | Mean SG (mg/dL) | HbA1c (%) | TAR >250 mg/dL (%) | TAR >180 mg/dL (%) | TBR <70 mg/dL (%) | TBR <54 mg/dL (%) | %CV | |
| Medtronic 670G | Garg—DTT, 2017 | 68.8/67.2 | 148.3/158.5 | 6.8/7.1 | 1.3/2.8a | 22.8/30.0 | 3.4/2.8 | 0.6/0.5a | 30.3/32.2 | Forlenza—DTT, 2018 | 65.0 | 162 | 7.5 | 10.3 | 32.0 | 3.0 | 0.8 | 33.7 |
| Medtronic 780G | Carlson—DTT, 2021 | 75.1/72.7 | 147/150 | 7.0/7.1 | 4.3/5.6 | 22.6/24.9 | 2.3/2.4 | 0.5/0.6 | 33.7/35.7 | Not yet reported | ||||||||
| Tandem Control IQ | Brown—NEJM, 2019 | 71 | 156 | 7.06 | 5.2 | 27 | 1.58 | 0.29 | 34 | Breton—NEJM, 2020 | 67 | 162 | 7.0 | 7.8 | 31 | 1.6 | 0.2 | 38 |
| Insulet OP5 | Brown—DC, 2021 | 73.9 | 154 | 6.78 | 5.8 | 24.7 | 1.32 | 0.23 | 31.7 | Brown—DC, 2021 | 68.0 | 160 | 6.99 | 9.6 | 30.2 | 1.78 | 0.32 | 37.0 |
| CamAPS FX | Tauschmann—Lancet, 2018 | 65 | 160.2 | 7.4 | 3.5b | 32 | 2.6 | 0.3b | 40 | Included in the adult/adolescent data | ||||||||
| Diabeloop | Benhamou—Lancet Digital Health, 2019 | 68.5 | 156.6 | 7.3 | 7.4 | 29.5 | 2.0 | 0.2 | 31.0 | Not yet reported | ||||||||
a
The Garg 670G trial reported TBR <50 mg/dL instead of <54 mg/dL and TAR >300 mg/dL instead of >250 mg/dL.
b
The Taushman CamAPS Fx trial reported TBR <2.8 mM instead of <3.0 mM and TAR >16.7 mM instead of 13.9 mM.
CV, coefficient of variation; HbA1c, hemoglobin A1c; SG, sensor glucose; TAR, time above range; TBR, time below range; TIR, time in range.