Table 2.
Hybrid closed loop systems that are approved, pending approval or in the clinical trial phase.
| Closed loop system | Safety | Efficacy | Approval status | Key references |
|---|---|---|---|---|
| Medtronic 670G Hybrid Closed Loop System | No severe adverse events related to algorithm | No controlled trial data available | Approved in the USA and Europe; Commercially available |
Garg 2017 (30) Forlenza 2019 (33) |
| Tandem Control-IQ | 1 DKA event unrelated to algorithm, no severe hypoglycaemia |
TIR increased 11 percentage points1 (95% CI, 9 to 14; p<0.001) TIR 11 increased percentage points2 (p<0.0001) HbA1c reduction of 0.33%1 (95% CI, 0.53 to 0.13; p=0.001) |
Approved in the USA and Europe; Commercially available |
1Brown 2019 (43) 2Kovatchev 2020 (41) |
| CamAPS FX (CamDiab) | 1 DKA event unrelated to algorithm, 1 severe hypoglycaemia unrelated to algorithm |
TIR increased 11 percentage points
3 (95% CI, 8 to 14; p<0.001) TIR increased 11 percentage points4 (95% CI, 8 to 13; p<0.0001) HbA1c reduction of 0.36%4 (95% CI, 0.53 to 0.19; p<0.0001) |
Approved in Europe; Commercially available in the UK |
3Thabit 2015 (48) 4Tauschmann 2018 (49) |
| DLBG1 Hybrid Closed Loop System (Diabeloop) | 9 severe hypoglycaemia events unrelated to algorithm, no DKA events |
TIR increased 9 percentage points (95% CI, 6 to 12; p<0.0001) HbA1c reduction not significant |
Approved in Europe; Not yet commercially available |
Benhamou 2019 (85) |
| Omnipod Horizon Closed Loop System (Insulet) | No severe adverse events reported | No controlled trial data available | Awaiting approval | Sherr 2019 (61) |
| iLet (insulin-only; Beta Bionics) | No severe adverse events reported | No controlled trial data available | Awaiting approval | Ekhlaspour 2019 (13) |
| Tidepool Loop | No data available | No data available | Awaiting approval | No published data |
[TIR – time in range]