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. Author manuscript; available in PMC: 2019 Feb 1.
Published in final edited form as: Diabetes Obes Metab. 2017 Aug 10;20(2):245–256. doi: 10.1111/dom.13052

Table 1.

Fully automated closed-loop system studies

Reference Study design and CLS type Control arms N Setting Duration Meals Exercise Main outcomes and postprandial outcomes
Steil GM et al. 2006 26 Nonrandomized; single-hormone CSII (3-day) 10 Adults Inpatient 28 to 30-h Individualized: average between 45 and 88g of CHO - No difference in mean glucose between CSII and CLS; 2-h postprandial glycemia is higher than target with CLS, especially after breakfast.
Weinzimer SA et al. 2008 40 Randomized; single-hormone CLS + pre-meal priming bolus (25 to 50% of a CHO-matched bolus) 17 Adolescents (8 fully automated vs. 9 with meal priming bolus) Inpatient 34-h Unspecified - No difference in 24-h mean glucose levels and in night-time glucose levels; daytime plasma glucose levels and postprandial peak glucose levels were significantly reduced with CLS + pre-meal priming bolus compared with fully automated CLS
Atlas E et al. 2010 44 Uncontrolled; single-hormone - 7 Adults Inpatient 8-h or 24-h sessions Three mixed meals of 17.5 to 70g of CHO - Mean peak postprandial glucose levels = 12.4 ± 1.2 mmol/L; 73% of time in target range (3.9 – 10.0 mmol/L) and 27% of time > 10.0 mmol/L.
El-Khatib FH et al. 2010 45 Uncontrolled; dual-hormone - 11 Adults Inpatient 27-h Three meals, individualized (45–60% of kcal from CHO per meal) - Seventeen hypoglycemia episodes in 5 patients with slower insulin pharmacokinetic (PK) (0 episode in repeated experiment following adjustments of insulin PK parameter settings); hyperglycemic excursion following each meal; following adjustments, average time spent in target range was 74% and 51% for the faster and the slower PK groups, respectively.
Breton M et al. 2012 46 Randomized cross-over; single-hormone CSII 11 Adolescents and 27 adults Inpatient 22-h Variable meal CHO content (1.08 ± 0.24g of CHO per kg of body weight) 30-min 2 Algorithms were tested: standard control to range (sCTR) and enhanced control to range (eCTR): both CLS significantly improved overall time between 3.9 and 10.0 mmol/L with no difference for overall time between 4.4 and 7.8 mmol/L compared with CSII; reduced hypoglycemic risk with sCTR and no difference with eCTR compared with CSII
Ruiz JL et al. 2012 34 Nonrandomized; single-hormone Proportional-integral-derivative (PID) + insulin feedback (IFB) 4 Adolescents or adults Inpatient 24-h PID vs. 24-h PID + IFB Variable CHO content (254 ± 42g for 3 meals) with identical meals on both days - Higher mean blood glucose with PID control compared to PID + IFB; no difference in post-meal BG excursions or area under the curve between both controllers; reduced hypoglycemic event occurrence with PID + IFB (0 event) compared to PID alone (8 events).
Weinzimer SA et al. 2012 41 Randomized; single-hormone or insulin + pramlintide CLS + pre-meal pramlintide injections (30μg) 8 Adolescents or adults Inpatient 24-h CLS vs. 24-h CLS + pramlintide Variable CHO-content (84 +− 26g / meal) with identical meals on both days - With fully automated CLS, 75% of sensor glucose values were within target range, although lower during the day (63%); in CLS + pramlintide, there was a significant delay in time to peak prandial blood glucose and glycemic excursions were reduced.
Dassau E et al. 2013 42 Uncontrolled; single-hormone CSII (outpatient) 15 Adults (18 tests) Inpatient 6.3-h (3.4 to 8.3-h) 30 ± 5 g of CHO - Average time in target (4.4 – 10.0 mmol/L) = 70%; no hypoglycemic event; improved blood glucose control as compared with outpatient CSII in uncontrolled conditions.
Mauseth R et al. 2013 47 Uncontrolled; single-Hormone - 7 Adults Inpatient 24-h 30g CHO breakfast and 60g CHO lunch - Mean blood glucose through experiment = 9.2 mmol/L with 65% of time spent in target range (3.9 – 10.0 mmol/L); 4-h post-meal blood glucose was within target for 64% and 16% of the time following the 30 and 60g meals, respectively.
Turksoy K et al. 2013 48 Uncontrolled; single-hormone - 3 Adults (7 tests) Inpatient 32- or 60-h 8 meals, variable CHO content (30–115g) Yes, variable duration Glucose remained within target range (3.9 – 10.0 mmol/L) 62% of the time, and 56% of the time following meals.
Cameron F et al. 2014 49 Uncontrolled; single-hormone - 2 Cohorts with distinctive algorithms; 4 and 6 Adults Inpatient 32-h Five meals of 0.8 to 1.2g CHO/kg bodyweight Walking only Results for the second cohort, following algorithm improvements : mean sensor glucose = 8.0 ± 2.4 mmol/L with 75% of sensor readings between 3.9 and 10.0 mmol/; 9% of time spent >13.9 mmol/L after 3 hours postprandial; one hypoglycemic event.
Blauw H et al. 2016 39; Previous studies 38,37,50 Randomized cross-over; dual-hormone CSII 10 Adults Outpatient 72-h Unspecified (uncontrolled) Unspecified (Allowed) No difference in median glucose levels; increased time spent in target range (3.9 – 10.0 mmol/L) with the CLS compared with CSII; no difference for postprandial median glucose or time spent in hyperglycemia (>10.0 mmol/L) for breakfast and dinner but improved postprandial glucose control for lunch with CLS compared with CSII.

CSII: continuous subcutaneous insulin infusion; CLS: closed-loop system; CHO: carbohydrate