Paolo Rossetti1, Carmen Quirós2, Vanessa Moscardó3, Anna Comas4, Marga Giménez2, F Javier Ampudia-Blasco5, Fabián León4, Eslam Montaser3, Ignacio Conget2, Jorge Bondia3, Josep Vehí4. 1. 1 Internal Medicine Department, Hospital Francesc de Borja , Gandía, Spain . 2. 2 Diabetes Unit, Endocrinology Department, Hospital Clínic i Universitari , Barcelona, Spain . 3. 3 Instituto Universitario de Automática e Informática Industrial, Universitat Politècnica de València , Valencia, Spain . 4. 4 Institute of Informatics and Applications, University of Girona , Girona, Spain . 5. 5 Diabetes Reference Unit, Endocrinology and Nutrition Department, Hospital Clínico Universitario de Valencia , Valencia, Spain .
Abstract
BACKGROUND: Postprandial (PP) control remains a challenge for closed-loop (CL) systems. Few studies with inconsistent results have systematically investigated the PP period. OBJECTIVE: To compare a new CL algorithm with current pump therapy (open loop [OL]) in the PP glucose control in type 1 diabetes (T1D) subjects. METHODS: A crossover randomized study was performed in two centers. Twenty T1D subjects (F/M 13/7, age 40.7 ± 10.4 years, disease duration 22.6 ± 9.9 years, and A1c 7.8% ± 0.7%) underwent an 8-h mixed meal test on four occasions. In two (CL1/CL2), after meal announcement, a bolus was given followed by an algorithm-driven basal infusion based on continuous glucose monitoring (CGM). Alternatively, in OL1/OL2 conventional pump therapy was used. Main outcome measures were as follows: glucose variability, estimated with the coefficient of variation (CV) of the area under the curve (AUC) of plasma glucose (PG) and CGM values, and from the analysis of the glucose time series; mean, maximum (Cmax), and time to Cmax glucose concentrations and time in range (<70, 70-180, >180 mg/dL). RESULTS: CVs of the glucose AUCs were low and similar in all studies (around 10%). However, CL achieved greater reproducibility and better PG control in the PP period: CL1 = CL2<OL1<OL2 (PGmean 123 ± 47 and 125 ± 44 vs. 152 ± 53 and 159 ± 54 mg/dL) and Cmax OL 217.1 ± 67.0 mg/dL versus CL 183.3 ± 63.9 mg/dL, P < 0.0001. Time-in-range was higher with CL versus OL (80% vs. 64%; P < 0.001). Neither the time below 70 mg/dL (CL 6.1% vs. OL 3.2%; P > 0.05) nor the need for oral glucose was significantly different (CL 40.0% vs. OL 22.5% of meals; P = 0.054). CONCLUSIONS: This novel CL algorithm effectively and consistently controls PP glucose excursions without increasing hypoglycemia. Study registered at ClinicalTrials.gov : study number NCT02100488.
RCT Entities:
BACKGROUND: Postprandial (PP) control remains a challenge for closed-loop (CL) systems. Few studies with inconsistent results have systematically investigated the PP period. OBJECTIVE: To compare a new CL algorithm with current pump therapy (open loop [OL]) in the PP glucose control in type 1 diabetes (T1D) subjects. METHODS: A crossover randomized study was performed in two centers. Twenty T1D subjects (F/M 13/7, age 40.7 ± 10.4 years, disease duration 22.6 ± 9.9 years, and A1c 7.8% ± 0.7%) underwent an 8-h mixed meal test on four occasions. In two (CL1/CL2), after meal announcement, a bolus was given followed by an algorithm-driven basal infusion based on continuous glucose monitoring (CGM). Alternatively, in OL1/OL2 conventional pump therapy was used. Main outcome measures were as follows: glucose variability, estimated with the coefficient of variation (CV) of the area under the curve (AUC) of plasma glucose (PG) and CGM values, and from the analysis of the glucose time series; mean, maximum (Cmax), and time to Cmax glucose concentrations and time in range (<70, 70-180, >180 mg/dL). RESULTS: CVs of the glucose AUCs were low and similar in all studies (around 10%). However, CL achieved greater reproducibility and better PG control in the PP period: CL1 = CL2<OL1<OL2 (PGmean 123 ± 47 and 125 ± 44 vs. 152 ± 53 and 159 ± 54 mg/dL) and Cmax OL 217.1 ± 67.0 mg/dL versus CL 183.3 ± 63.9 mg/dL, P < 0.0001. Time-in-range was higher with CL versus OL (80% vs. 64%; P < 0.001). Neither the time below 70 mg/dL (CL 6.1% vs. OL 3.2%; P > 0.05) nor the need for oral glucose was significantly different (CL 40.0% vs. OL 22.5% of meals; P = 0.054). CONCLUSIONS: This novel CL algorithm effectively and consistently controls PP glucose excursions without increasing hypoglycemia. Study registered at ClinicalTrials.gov : study number NCT02100488.