Kropff et al. (2015) [16] |
Evening and night closed-loop control of insulin |
Age 18–69, HbA1c 7.5%–10.0%; experienced insulin pump users, trained in carbohydrate counting (n=32) |
2 Weeks, open loop training, ability to manage CGM data and pump |
% Time spent in the target range (glucose 70–180 mg/dL) |
SAP, using built-in bolus calculator; 58.1%±9.4% |
SAP plus evening and night closed loop insulin delivery; 66.7%±10.1% (P<0.0001) |
8-Week, free-living conditions, multi-center, randomized crossover study |
Thabit et al. (2015) [17] |
Day and night hybrid closed-loop control of insulin |
Age ≥18, HbA1c 7.5%–10.0%; C-peptide <0.1 ng/mL, long-term use of insulin pump (n=58) |
4–6 Weeks, weekly visit with adjustment of pump therapy |
% Time spent in the target range (glucose 70–180 mg/dL) |
SAP, standard bolus calculator; 56.8%±14.2% |
Day and night hybrid closed-loop insulin delivery, MPC treat-to-target algorithm; 67.7%±10.6% (P<0.001) |
12-Week, free-living conditions, multi-center, randomized crossover study |
Bergenstal et al. (2016) [13] |
Day and night hybrid closed-loop control of insulin |
Type 1 diabetes >2 years, insulin pump >6 months, HbA1c <10% |
2 Weeks without automated feature |
Not applicable (safety study) |
None (safety study) |
Day and night hybrid closed-loop insulin delivery, PID algorithm |
12-Week, single arm safety study of the first FDA-approved artificial pancreas |
El-Khatib et al. (2017) [15] |
Fully-automated bihormonal bionic pancreas |
Age ≥18, type 1 diabetes >1 year, insulin pump >6 months (59% using SAPs at baseline) |
Washout period between period of 3 or 10 days depending on centers |
Mean sensor glucose and % time spent in glucose <60 mg/dL in day 2–11 |
CSII with or without SAP; mean 162±28 mg/dL, <60 mg/dL in 1.9% |
Fully-automateda bihormonal bionic pancreas; 140±11 mg/dL, <60 mg/dL in 0.6% (P<0.0001) |
11-Day, free-living conditionsb, multi-center, randomized crossover study |