ArticleJournal of endocrinological investigation2026
Safety and glycemic outcomes of DBLG1 coupled to the DANA-i pump in adults and adolescents with type 1 diabetes mellitus. The SP8 trial.
Article in Journal of endocrinological investigation, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04190277 (Safety Assessment of DBLUS System in Adolescent and Adult Patients With Type 1 Diabetes and Assessment of Its Clinical Efficacy in a Randomized Trial for 3 Months Followed by an Extension Period), which is not on this map. Not yet cited in PubMed.
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Safety Assessment of DBLUS System in Adolescent and Adult Patients With Type 1 Diabetes and Assessment of Its Clinical Efficacy in a Randomized Trial for 3 Months Followed by an Extension Period
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15 authors.
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Abstract
purposeDBLG1 is a hybrid closed-loop (CL) system interoperable with ViCentra Kaleido and Roche Insight pumps. The SP8 trial investigated the safety and glycemic outcomes of DBLG1 coupled to the DANA-i pump (DBLG1-DANAi) in adults and adolescents with type 1 diabetes mellitus (T1D).
methodsThe safety of DBLG1-DANAi (primary outcome of SP8) was evaluated using two criteria: (i) the incidence of serious adverse device events (SADEs) and (ii) the time spent in hypoglycemia (time below range 70 mg/dL [3.9 mmol/L], TBR70) with DBLG1-DANAi compared to an SAP (sensor-augmented pump) system. Secondary outcomes included non-serious adverse events and standard glycemic metrics. Five months after its start, the trial was halted due to the COVID-19 crisis. One hundred and forty (140) of the 148 planned adults had already been included in the study, as well as all planned adolescents (N = 36).
resultsThe intention-to-treat (ITT) population included 105 adult and 36 adolescent participants in whom no SADE was observed with DBLG1-DANAi. The per-protocol (PP) population consisted of 73 adults and 18 adolescents who spent two weeks with SAP, followed by two weeks with DBLG1-DANAi. No increase in TBR70 was observed during the DBLG1-DANAi period. Furthermore, the time spent in the glucose level range of 70-180 mg/dL [3.9-10.0 mmol/L] (time in range, TIR70-180) increased significantly with DBLG1-DANAi, both in adults (+ 10.5%; p < 0.0001) and adolescents (+ 16.0%; p < 0.0001).
conclusionDuring the two-week study period, DBLG1 was interoperable with the DANA-i pump. This result requires confirmation in future long-term studies. CLINICALTRIALS: GOV ID: NCT04190277.
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