Table 1.
Key clinical trials of closed-loop insulin delivery in children and young people using commercialized systems.
| Age group (no. of participants) | Duration of closed-loop treatment | Type of study | Comparator | Baseline HbA1c | Glycaemic outcomes | Year and Key reference |
|---|---|---|---|---|---|---|
| Medtronic 670G HCL / 780G AHCL | ||||||
| 14-21 years (n = 30) |
3 months (670G) | Single-arm, non-randomized | None | 61mmol/mol (7.7%) | TIR 67%, no control arm. | 2017 (21, 22) |
| 7-13 years (n = 105) |
3 months (670G) | Single-arm, non-randomized | None | 63mmol/mol (7.9.%) | TIR 65%, no control arm. | 2019 (23) |
| 14-29 years (n = 113) |
3 months (AHCL) | Randomized, crossover | 670G HCL | 63mmol/mol (7.9%) | TIR 67% with 780G and 63% with 670G (p < 0.0001). | 2021 (24) |
| 7-80 years (n = 59) [7-13 years (n = 19); 14–21 years (n = 14)] |
4 weeks (AHCL) | Randomized crossover | 670G PLGM | 60mmol/mol (7.6%) | TIR 70% overall, increased 12 percentage points compared to control (p < 0.001); increased 12 percentage points in 7-13yr olds and 14 percentage points in 14-21yr olds compared to control. | 2021 (25) |
| Tandem Control IQ | ||||||
| 6-13 years (n = 101) |
16 weeks | Randomized, parallel | Sensor-augmented pump | 61mmol/mol (7.7%) | TIR 67%, increased 11 percentage points compared to control (p < 0.001). | 2020 (26) |
| 14-24 years (n = 63) |
6 months | Randomized, parallel | Sensor-augmented pump | 65mmol/mol (8.1%) | TIR 64%, increased 13 percentage points compared to control (p < 0.001). | 2020 (27) |
| 2-5 years (n = 12) |
3 days | Single-arm, non-randomized | None | 56mmol/mol (7.3%) | TIR 71%, no control arm. | 2020 (28) |
| CamAPS FX (CamDiab) | ||||||
| 10-18 years (n = 12) |
3 weeks | Randomized, crossover | Sensor-augmented pump | 69mmol/mol (8.5%) | TIR 67%, increased 19 percentage points compared to control (p < 0.001). | 2016 (29) |
| 6-65 years (n = 86) [6-12 years (n = 33); 13-21 years (n = 19)] |
12 weeks | Randomized, parallel | Sensor-augmented pump | 68mmol/mol (8.3%) | TIR 65% overall, increased 11 percentage points compared to control (p < 0.0001); increased 15 percentage points in 6-12yr olds and 14 percentage points in 13-21yr olds compared to baseline. | 2018 (30) |
| 1-7 years (n = 24) |
3 weeks | Randomized, crossover | Closed-loop with diluted insulin U20. | 57mmol/mol (7.4%) | TIR 70% closed-loop with U100 and 72% closed-loop with U20, no difference (p=0.16). | 2018 (31) |
HCL, hybrid closed-loop; AHCL, advanced hybrid closed-loop; PLGM, predictive low glucose management; TIR, time in range; HbA1c, glycated hemoglobin.