697-P: Insulin Pump Interoperability of the Diabeloop DBLG1 System

First Generation of a Modular Interoperable Closed-Loop System for Automated Insulin Delivery in Patients With Type 1 Diabetes: Lessons From Trials and Real-Life Data

“…This report includes all available sources of data, that is, three randomized control trials (RCTs) and five surveys on real-life data. [9][10][11][12][13][14][15][16] Among the three RCTs, SP7 was the pivotal trial that led to CE-marking of the product. SP7 was a randomized, crossover trial performed within 12 centers in 63 adult patients, with two periods of 12 weeks each under either open-loop or closed-loop therapy, separated with an eight-week washout period.…”

“…13 In other European countries, the distribution was set with the Roche Insight pump, starting March 2021, leading to several real-life reports among 62 patients in Spain after three months, 14 3706 patients in Germany after one year of use 15 and 6658 patients in Europe after one year. 16 Of note, this latter report included patients from the following countries: Belgium, Germany, Italy, Netherland, Spain, and Switzerland. When reporting the sum of the patients, we excluded the numbers in Spain and Germany in order for them not be counted twice.…”

“…We looked at the percentage of patients achieving the international recommendations for TIR and TBR 17,18 among our three largest cohorts: 47.5% of the 62 patients in the Spanish cohort, 55.9% of the 3706 patients in the German cohort and 53% of the 6658 patients in the European cohort, respectively, achieved both a TIR>70% and a TBR<4%. [14][15][16] Finally, an important point raised in the pivotal SP7 study was a positive correlation between improvement in outcome and baseline HbA1c. Thus, improvements were observed across the whole range of baseline HbA1c values: patients with hyperglycemic concern spent a longer time in the target glucose range, and patients with lower glucose values at baseline spent a reduced proportion of time in the low glucose range.…”