Table 2: Clinical and real-world studies involving Medtronic's MiniMed 780G9–12.
| Study | System | Study design | Sample | TIR (baseline, final, change, p-value) | HbA1c (baseline, final, change, p-value) | Time below range (baseline, final, change, p-value) | Time above range (baseline, final, change, p-value) | Adverse events |
|---|---|---|---|---|---|---|---|---|
| Carlson et al. (2021)9 | MiniMed™ 780G (Medtronic, Dublin, Ireland) | Single-arm, multicentre prospective clinical study | People with T1DM (N=157; age range: 14–75 yrs) | 68.8% | 7.5% | 3.3% | 27.9% | Three serious adverse events, all unrelated to the system: one severe hypoglycaemic event during run-in, one case of appendicitis and one of sepsis |
| 74.5% | 7.0% | 2.3% | 23.1% | |||||
| +5.7% (+1.4 hrs/day) | -0.5% | -1.0% (+14 mins/day) | -4.8% (-1.1 hrs/day) | |||||
| p<0.001 | p<0.001 | p<0.001 | p<0.001 | |||||
| Collyns et al. (2021)10 | MiniMed 780G | Dual centre randomized crossover trial consisting of two 4-week periods, with Medtronic's MiniMed 780G (closed-loop) system during one 4-week period and SAP + PLGM therapy during the other | People with T1DM (N=59; age range: 7–80 yrs) | Overall: 59.0% | Overall: 7.6% | Overall: 3.1% | Overall: 37.9% | A total of 5 of the 37 adverse events were related to the device; all were skin reactions |
| PLGM: 57.9%; closed-loop: 70.4% | N/A | PLGM: 2.5%; closed-loop: 2.1% | PLGM: 39.6%; closed-loop: 27.5% | |||||
| PLGM: -1.1% (-14 mins/day); closed-loop: +11.4% (+2.6 hrs/day) | N/A | PLGM: -0.6% (-9 mins/day); closed-loop: -1.0% (+14 mins/day) | PLGM: +1.7% (+24 mins/day); closed-loop: -10.4% (-2.5 hrs/day) | |||||
| PLGM: p<0.001; closed-loop: p<0.001 | N/A | PLGM: p<0.001; closed-loop: p<0.001 | PLGM: p<0.001; closed-loop: p<0.001 | |||||
| Nimri et al. (2021)11 | MiniMed 780G | Single-arm prospective clinical study | Adolescents and adults with T1DM (N=12; median age: 17 yrs) | 68.4% | 7.1% | 4.0% | 27.6% | No serious adverse events occurred |
| 74.0% | 6.8% | 2.6% | 23.4% | |||||
| +5.6% (+1.4 hrs/day) | -0.3% | -1.4% (-20 mins/day) | -4.2% (-1.0 hrs/day) | |||||
| p=0.06 | p=0.0027 | p=0.27 | N/A | |||||
| Beato-Víbora et al. (2021)12 | MiniMed 780G | Single-arm prospective clinical study | Participants with T1DM (N=52; mean age: 43 yrs) | 67.3% | 7.2% | N/A | N/A | N/A |
| 79.6% | N/A | N/A | N/A | |||||
| +12.3% (+3.1 hrs/day) | N/A | No differences found | No differences found | |||||
| p=0.001 | N/A | N/A | N/A |
HbA1c = glycated haemoglobin; hrs = hours; mins = minutes; N/A = not applicable; PLGM = predictive low glucose management; SAP = sensor-augmented pump; T1DM = type 1 diabetes; TIR = time in range; yrs = years.