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Among 63 adults with type 1 diabetes who completed both 12-week periods, time in the 70-180 mg/dL range was 68.5% with DBLG1 against 59.4% with pump and sensor alone. Time below 70 mg/dL fell from 4.3% to 2.0%. HbA1c and patient satisfaction did not differ. The committee rated the system a moderate improvement (ASA III) for adults whose HbA1c stayed at 8% or above on pump therapy. It noted that most trial patients had a lower HbA1c and that the trial used an earlier generation of the system. Trial patients also had 48 hours in hospital and round-the-clock support from a nurse and an engineer. 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HAS describes the module that the maker calls physiological machine learning as predefined equations whose 15 parameters a genetic algorithm adapts to 48 hours of the patient's data. It calls the other modules, including long-term self-learning, deterministic. In the maker's simulation, that module made better dosing decisions than the expert-system module 61.81% of the time."},"evidence":[{"kind":"assessment report","citation":"Haute Autorité de santé, Commission nationale d'évaluation des dispositifs médicaux et des technologies de santé (CNEDiMTS). Avis de la CNEDiMTS du 28 janvier 2020, DBLG1, système de boucle semi-fermée dédié à la gestion automatisée du diabète de type 1 (dossier 5998, version publiée après occultation). 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Les données disponibles mettent en évidence un effet favorable sur différents paramètres de suivi instantané de l'équilibre glycémique."}],"replication":{"produced_by":["A sensor measured interstitial glucose every 5 minutes and sent it to the smartphone.","The algorithm drove the insulin pump automatically, and patients confirmed mealtime doses.","Trial patients had 48 hours of training in hospital and round-the-clock support from a nurse and a Diabeloop engineer."],"must_hold":["Patients are adults with type 1 diabetes on pump therapy who receive specific training and education.","Patients use the system in closed-loop mode at least 75% of the time, the threshold that HAS set for continuing."],"echoes":[]},"paired_incident":null,"headline":"*DBLG1* closed loop kept glucose in range longer in a French trial","metric":"68.5% of the time in the target glucose range against 59.4%","comparator":{"against":"Open-loop systems in which an insulin pump and a glucose sensor work independently","before":"59,4 (± 1,3) % of time in 70-180 mg/dL with pump and sensor in the SP7 trial","after":"68,5 (± 1,2) % with DBLG1, rated amélioration modérée du service attendu (ASA III)","basis":"measured","quote":"En raison des limites des études analysées, la Commission s'est prononcée pour une amélioration modérée du service attendu (ASA III) du système DBLG1 par rapport aux systèmes (dits en boucle ouverte), composés d'une pompe à insuline externe et d'un capteur de mesure du taux de glucose interstitiel fonctionnant indépendamment, dans les indications et conditions d'utilisation retenues.","url":"https://www.has-sante.fr/upload/docs/evamed/CNEDIMTS-5998_DBLG1%205998_occultation.pdf"},"later":null,"value":null,"developer_country":"France","deployer_country":"France","unrated_because":"HAS backed reimbursement on the strength of a 12-week trial of an earlier version, before the system was on the market, so the benefit in routine use is intended.","brief_notes":null,"brief":null,"revisions":[{"date":"2026-10-31","change":"Added the record from the finding of Haute Autorité de santé (CNEDiMTS).","source":"https://www.has-sante.fr/upload/docs/evamed/CNEDIMTS-5998_DBLG1%205998_occultation.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by an assessment body","claim_basis":"Sources: one independent assessment report. 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