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Master Thesis

Évaluation d'un nouvel algorithme d'insulinothérapie en boucle semi-fermée, en période prandiale‎ : l'étude pilote Diabeloop SP6-0

Abstract : OBJECTIVE: There is room for improvement of the algorithms used in closed-loop insulin therapy over the prandial period. This pilot study evaluated the efficacy and safety of the Diabeloop algorithm (Model Predictive Control type) during the postprandial period. METHODS: A bicentric clinical trial consisted of the comparison of interstitial glucose levels for two 5-hour periods (with/without the algorithm) following ingestion of a standard lunch. On the control day, the amount of insulin delivered by the pump was determined in accordance with the patient's usual parameters. On the test day, 50 or 75% of the theoretical bolus required was delivered, while the algorithm, informed of carbohydrate intake, proposed changes to insulin delivery every 15 minutes using modelling to forecast glucose levels. The primary endpoint was percentage time spent at near normoglycemia (70-180 mg/dl). RESULTS: 12 patients with type I diabetes (9 men, age 35.6±12.7 years, HbA1c 7.3±0.8%) were included. The percentage time spent in the target range was 84.5±20.8 (test day) vs. 69.2±33.9% (control day) (p=0.11). The percentage time spent in hypoglycemia < 70 mg/dl was 0.2±0.8 (test) vs. 4.4±8.2% (control, p=0.18). Interstitial glucose at the end of the test (5h) was 127.5±40.1 (test) vs. 146±53.5 mg/dl (control, p=0.25). The insulin doses did not differ and no differences were observed between the 50% and 75% boluses. CONCLUSION: In a semi-closed configuration with manual priming boluses (25% or 50% reduction), the Diabeloop v1 algorithm was as successful as the manual method in determining the prandial bolus, without any exposure to excessive hypoglycemic risk.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-01062616
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Submitted on : Wednesday, September 10, 2014 - 10:46:58 AM
Last modification on : Wednesday, July 15, 2020 - 8:58:04 AM
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Marie-Aude Quémerais Durieu. Évaluation d'un nouvel algorithme d'insulinothérapie en boucle semi-fermée, en période prandiale‎ : l'étude pilote Diabeloop SP6-0. Médecine humaine et pathologie. 2014. ⟨dumas-01062616⟩

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