Alice Adenis, France
Diabeloop Research and developmentAuthor Of 1 Presentation
OP016 - REAL LIFE RESULTS OF DBLG1 SYSTEM IN EUROPE (ID 812)
Abstract
Background and Aims
This study aims to assess the performance of DBLG1 System (Closed Loop) on patients equipped with DBLG1 System in Switzerland (CH), Germany (DE), Spain (ES), Italy (IT) and the Netherlands (NL). 6658 patients gave their consent to join the study.
Methods
The glycemic data of the patients are analyzed between April 2021 and April 2022. For each patient, the Time In Range 70-180 mg/dL (TIR), time below range 70 (TBR70) and 54 mg/dL (TBR54) and time above range (TAR) 180 and 250 mg/dL are computed. For comparison, the baseline TIR is estimated using the HbA1c measured before using the device (available for 4162 patients). The statistics are then aggregated by country and overall.
Results
For the 4162 patients, the overall median TIR is 71.79% [65.3, 78] – with a baseline TIR of 54.88% [40.2, 67.0]. For the 6658 patients, we observe a median TIR of 71% [63.8, 77.7]. The median TBR70 and TBR54 are 0.98% [0.5, 1.8] and 0.14% [0.06, 0.3] respectively. The results are similar across all the countries as shown in Fig. 1.
Conclusions
The use of DBLG1 system in real life in Europe keeps its promises. Results are consistent with previous clinical trials NCT02987556 (SP7) and NCT04190277 (SP8) and are in compliance with the international recommendations for the TIR (>70%) and the TBR (<4%) for 3515 patients.
Presenter of 1 Presentation
OP016 - REAL LIFE RESULTS OF DBLG1 SYSTEM IN EUROPE (ID 812)
Abstract
Background and Aims
This study aims to assess the performance of DBLG1 System (Closed Loop) on patients equipped with DBLG1 System in Switzerland (CH), Germany (DE), Spain (ES), Italy (IT) and the Netherlands (NL). 6658 patients gave their consent to join the study.
Methods
The glycemic data of the patients are analyzed between April 2021 and April 2022. For each patient, the Time In Range 70-180 mg/dL (TIR), time below range 70 (TBR70) and 54 mg/dL (TBR54) and time above range (TAR) 180 and 250 mg/dL are computed. For comparison, the baseline TIR is estimated using the HbA1c measured before using the device (available for 4162 patients). The statistics are then aggregated by country and overall.
Results
For the 4162 patients, the overall median TIR is 71.79% [65.3, 78] – with a baseline TIR of 54.88% [40.2, 67.0]. For the 6658 patients, we observe a median TIR of 71% [63.8, 77.7]. The median TBR70 and TBR54 are 0.98% [0.5, 1.8] and 0.14% [0.06, 0.3] respectively. The results are similar across all the countries as shown in Fig. 1.
Conclusions
The use of DBLG1 system in real life in Europe keeps its promises. Results are consistent with previous clinical trials NCT02987556 (SP7) and NCT04190277 (SP8) and are in compliance with the international recommendations for the TIR (>70%) and the TBR (<4%) for 3515 patients.