Clinical evaluation of a decision support system for glucose infusion in hypoglycaemic clamp experiments

Abstract Aim To provide a preliminary evaluation of the accuracy and safety of Gluclas decision support system suggestions in a hypoglycaemic clamp study. Methods This analysis was performed using data from 32 participants (four groups with different glucose‐insulin regulation: post Roux‐en‐Y gastri...

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Published in:Diabetes, obesity & metabolism obesity & metabolism, 2023-12, Vol.25 (12), p.3709-3715
Main Authors: Pavan, Jacopo, Herzig, David, Tripyla, Afrodity, Dalla Man, Chiara, Bally, Lia, Del Favero, Simone
Format: Article
Language:English
Subjects:
Accuracy
Clinical decision making
Decision support systems
Diabetes
Gastrectomy
Gastric bypass
Gastrointestinal surgery
Glucose
Glucose monitoring
Hypoglycemia
Insulin
Obesity
Safety
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Summary:Abstract Aim To provide a preliminary evaluation of the accuracy and safety of Gluclas decision support system suggestions in a hypoglycaemic clamp study. Methods This analysis was performed using data from 32 participants (four groups with different glucose‐insulin regulation: post Roux‐en‐Y gastric bypass with and without postprandial hypoglycaemia syndrome, postsleeve gastrectomy and non‐operated controls) undergoing Gluclas‐assisted hypoglycaemic clamps (target: 2.5 mmol/L for 20 minutes at 150 minutes after oral glucose ingestion). Gluclas provided glucose infusion rate suggestions upon manual entry of blood glucose values (every 5 minutes), which were either followed or overruled by investigators after critical review. Accuracy and safety were evaluated by mean absolute error (MAE), mean absolute percentage error (MAPE), average glucose level, coefficient of variation (CV) and minimal glucose level during the 20‐minute hypoglycaemic period. Results Investigators accepted 84% of suggestions, with a mean deviation of 30.33 mg/min. During the hypoglycaemic period, the MAE was 0.16 (0.12‐0.24) (median [interquartile range]) mmol/L and the MAPE was 6.12% (4.80%‐9.29%). CV was 4.90% (3.58%‐7.27%), with 5% considered the threshold for sufficient quality. The minimal glucose level was 2.40 (2.30‐2.50) mmol/L. Conclusions Gluclas achieved sufficiently high accuracy with minimal safety risks in a population with differences in glucose‐insulin dynamics, underscoring its applicability to various patient groups.
ISSN:1462-8902
1463-1326
DOI:10.1111/dom.15265