Table 7.
Bihormonal Closed-Loop Studies in Various Settings
| System | n | Study Outcomes: Closed Loop vs Open Loop | ||
|---|---|---|---|---|
| Average Glucose ± SD [mg/dL (mmol/L)] | % CGM Time 70–180 mg/dL (3.9–10.0 mmol/L) | % CGM Time <70 mg/dL (3.9 mmol/L) | ||
| Median (IQR1, IQR3) or Median (IQR) | ||||
| Bionic Pancreas 2010 (33)a | 6 | Fast PK controller 140 ± 9 (7.8 ± 0.5) | Fast PK controller 74% | Fast PK controller <1% |
| Slow PK controller 173 ± 18 (9.6 ± 1.0) | Slow PK controller 56% | Slow PK controller <1% | ||
| Bionic Pancreas 2014 (120)b | 24 | Meal priming 129 ± 8 (7.2 ± 0.4) | Meal priming 80% | 5.1% vs 3.6% |
| No meal priming 140 ± 8 (7.8 ± 0.4) | No meal priming 70% | |||
| Bionic Pancreas 2014 (121) | 20 | Adults (no control group) 138 ± 14 (7.7 ± 0.8) | Day 2–5 86.5% | 4.8% |
| 32 | Adolescents 138 ± 18 (7.7 ± 1.0) vs 157 ± 27 (8.7 ± 1.5) | Day 2–5 86.9% vs 66.7% | 2.6% vs 3.3% | |
| Bionic Pancreas 2016 (122) | 19 | Day 2–5 136.8 ± 10.8 (7.6 ± 0.6) vs 167.4 ± 30.6 (9.3 ± 1.7) | 80.6% vs 57.6% | <2.9% vs 6.1% |
| Bionic Pancreas 2017 (34) | 43 | 140.4 ± 10.8 (7.8 ± 0.6) vs 162 ± 28.8 (9.0 ± 1.6) | 78.4% vs 61.9% | <60 mg/dL (3.3 mmol/L) |
| 0.65% vs 1.9% | ||||
| Inreda bihormonal closed loop 2010 (123) | 5 | Not reported | 60% vs 31% | 11% vs 19% |
| Inreda bihormonal closed loop 2012 (124) | 10 | 156.6 vs 162 (8.7 vs 9.0) (SD not reported) | 61.2% vs 62.3% | 4.1% vs 5.3% |
| Bihormonal: Oregon University 2014 (125) | 7 | 153 (8.5) | 73.10% | 1.30% |
| Inreda bihormonal closed loop 2014 (126) | 11 | Day 1: 132 (40) [7.38 (2.23)] vs 149 (15) [8.27 (0.83)] | Day 1: 79.2% vs 67.2% | Day 1: 2.1% vs 0.7% |
| Day 2: 139 (41) [7.70 (2.29)] vs 159 (16) [8.84 (0.87)] | Day 2: 76.5% vs 66.0% | Day 2: 0% vs 2.8% | ||
| Inreda Diabetic 2016 (127) | 10 | 133.2 (131.4–145.8) [7.4 (7.3–8.1)] vs 145.8 (133.2–167.4) [8.1 (7.4–9.3)] | 84.7% vs 68.5% | 1.3% vs 2.4% |
| Haidar 2013 (128) | 15 | 140 ± 20 (7.8 ± 1.1) vs 142 ± 34 (7.9 ± 1.9) | 70.7% (46.4%–88.4%) vs 57.3 (25.2–71.8) | 0.0% (0.0%–3.0%) vs 10.2% (0.0%–13.0%) |
| Haidar 2015 (129) | 25 | 167.4 ± 25.2 (9.3 ± 1.4) | 72–180 mg/dL (4.0–10 mmol/L) | <72 mg/dL (4.0 mmol/L) |
| Single hormone: 145.8 ± 30.6 (8.1 ± 1.7) | Conventional 29% | 3.4% (0–11.0) conventional therapy | ||
| Dual hormone: 138.6 ± 30.6 (7.7 ± 1.7) | Single hormone 55% | 3.1% (0.0–6.9) insulin only | ||
| Dual hormone 63% | 0% dual hormone | |||
| Haidar 2016 (130) | 28 | Open Loop 121 (104–140) [6.7 (5.8–7.8)] | 72–180 mg/dL (4.0–10 mmol/L) | <72 mg/dL (4.0 mmol/L) |
| Single hormone 112 (104–122) [6.2 (5.8–6.8)] | Open loop 70% (58%–81%) | Open loop 14% (4%–28%) | ||
| Dual hormone 112 (104–126) [6.2 (5.8–7.0)] | Single hormone 91% (76%–97%) | Single hormone 5% (0%–13%) | ||
| Dual hormone 93% (81%–99%) | Dual hormone 1% (0%–8%) | |||
We use italics when our accepted standards for time in range and hypoglycemia thresholds were not used.
Abbreviation: IQR, interquartile range.
a
“Fast PK Group”: Model parameters include a 33-min time-to-peak (tmax) and 3.25-h time to 95% clearance (t95%). “Slow PK Group”: tmax of 65 min, t95% of 6.5 h.
b
Participants were randomized either to receive or not receive automatically adaptive meal-priming boluses.