Table 2.
Key randomized controlled trials of closed-loop insulin delivery using commercialised systems.
| Population | Duration | Comparator | Baseline HbA1c |
Safety outcomes | Glycaemic outcomes | CL usage | Key reference |
|---|---|---|---|---|---|---|---|
| Medtronic 670G HCL | |||||||
| N=120 Adults |
6 months | MDI or pump | 7.5% | 8 SH events [7 in control] 1 DKA event [2 in control] |
TIR ↑15 percentage points HbA1c ↓0.4 percentage points |
Median 89% | McAuley 2020 [68] |
| N=135 12-25 years |
6 months | MDI or pump | 8.0% | No SH or DKA events [0 in control] | TIR ↑7 percentage points HbA1c ↓0.3 percentage points |
Not stated | Abraham 2021 [32] |
| N=30 60+ years |
4 months | SAP | 7.6% | 3 SH events [2 in control] No DKA events [1 in control] |
TIR ↑6 percentage points HbA1c ↔ |
Median 93% | McAuley 2022 [69] |
| Medtronic 780G AHCL | |||||||
| N=113 14-29 years |
3 months | 670G HCL | 7.9% | 1 SH event [0 in control] No DKA events [0 in control] |
TIR ↓ (no mean difference stated) HbA1c ↓ (no difference stated) |
Median 86% | Bergenstal 2021 [31] |
| N=59 7-80 years |
4 weeks | 670G PLGM | 7.6% | No SH events [0 in control] No DKA events [1 in control] |
TIR ↑12 percentage points HbA1c not measured |
Mean 96% | Collyns 2021 [73] |
| Tandem Control IQ | |||||||
| N=168 14+ years |
6 months | SAP | 7.4% | No SH events [0 in control] 1 DKA event [0 in control] |
TIR ↑11 percentage points HbA1c ↓0.3 percentage points |
Median 90% | Brown 2019 [27] |
| N=101 6-13 years |
4 months | SAP | 7.6-7.9% | No SH or DKA events [0 in control] | TIR ↑11 percentage points HbA1c ↓0.4 percentage points |
Median 93% | Breton 2020 [30] |
| CamAPS FX | |||||||
| N=86 6+ years |
3 months | SAP | 8.2-8.3% | No SH events [0 in control] 1 DKA event [0 in control] |
TIR ↑11 percentage points HbA1c ↓0.4 percentage points |
Median 71% | Tauschmann 2018 [78] |
| N=133 (N=46 CamAPS FX) 6-18 years |
6 months | Pump | 8.2-8.3% | 4 SH events [3 in control] 2 DKA events [0 in control] |
TIR ↑7 percentage points (whole cohort), ↑15 percentage points (CamAPS FX cohort) HbA1c ↓0.3 percentage points (whole cohort), ↓1.1 percentage points (CamAPS FX cohort) |
Median 93% (CamAPS FX cohort) | Ware & Boughton 2022 [36] |
| N=74 1-7 years |
4 months | SAP | 7.3% | 1 SH event [0 in control] No DKA events [0 in control] |
TIR ↑9 percentage points HbA1c ↓0.4 percentage points |
Median 95% | Ware 2022 [25] |
| N=37 60+ years |
4 months | SAP | 7.4% | No SH event [2 in control] No DKA events [0 in control] |
TIR ↑9 percentage points HbA1c ↓0.2 percentage points |
Median 97% | Boughton 2022 [26] |
| Diabeloop DBLG1 | |||||||
| N=68 Adults |
3 months | SAP | 7.6% | 5 SH events [3 in control] No DKA events [0 in control] |
TIR ↑9 percentage points HbA1c ↔ |
Median 84% | Benhamou 2019 [29] |
| N=17 | 6 weeks | SAP | 7.0-7.6% | No SH or DKA events [0 in control] | TIR ↑ (no mean difference stated) HbA1c not measured |
Not stated | Kariyawasam 2022 [82] |
[CL – closed-loop. HCL – hybrid closed-loop. MDI – multiple daily injections. DKA – diabetic ketoacidosis. SH – severe hypoglycaemia. TIR – time in range (3.9-10.0mmol/L). HbA1c – glycated haemoglobin.AHCL – advanced hybrid closed-loop. SAP – sensor-augmented pump. PLGM – predictive low glucose management.]