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Purpose <p>DBLG1 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).</p> Methods <p>The 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&#xa0;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 (<i>N</i> = 36).</p> Results <p>The 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&#xa0;mg/dL [3.9–10.0 mmol/L] (time in range, TIR70-180) ​​increased significantly with DBLG1-DANAi, both in adults (+ 10.5%; <i>p</i> &lt; 0.0001) and adolescents (+ 16.0%; <i>p</i> &lt; 0.0001).</p> Conclusion <p>During the two-week study period, DBLG1 was interoperable with the DANA-i pump. This result requires confirmation in future long-term studies.</p> ClinicalTrials.gov ID <p>NCT04190277</p>

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Safety and glycemic outcomes of DBLG1 coupled to the DANA-i pump in adults and adolescents with type 1 diabetes mellitus. The SP8 trial

  • 期刊论文

  • 发表日期：

    2025年12月26日

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  • Sylvia Franc,
  • Y. Reznik,
  • C. Amadou,
  • A. Penfornis,
  • P. Schaepelynck,
  • H. Hanaire,
  • B. Delemer,
  • C. Le Tallec,
  • J. Beltrand,
  • N. Jeandidier,
  • S. Bensaid,
  • L. Orlando,
  • P. Hannaert,
  • P.-Y. Benhamou,
  • G. Charpentier

摘要

Purpose

DBLG1 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).

Methods

The 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).

Results

The 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).

Conclusion

During 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