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Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Copyright © 2017 Korean Endocrine Society
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
CONFLICTS OF INTEREST: No potential conflict of interest relevant to this article was reported.
Study | Feature | Patient characteristic | Primary endpoint | Intervention and result | Study design and setting | ||
---|---|---|---|---|---|---|---|
At screening | Run-in period | Control group (or period) | Intervention group (or period) | ||||
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 |
HbA1c, glycated hemoglobin; CGM, continuous glucose monitoring; SAP, sensor-augmented insulin pump; MPC, model predictive control; PID, proportional integral derivative; FDA, U.S. Food and Drug Administration; CSII, continuous subcutaneous insulin infusion.
aAllowing but not requiring qualitative meal announcement; bAn alarm was provided to study staff if the glucose level remained <50 mg/dL for >15 minutes.