Kessler Laurence, Thivolet Charles, Penfornis Alfred, Gouet Didier, Coffin Christine, Moret Myriam, Borot Sophie, Bekka Saïd, Sonnet Emmanuel, Joubert Michael, Lablanche Sandrine, Burtin Geoffrey, Di Piazza Fabio, van den Heuvel Tim, Cohen Ohad
CHRU Strasbourg, Strasbourg, France.
HCL (Lyon Sud) - Diab-eCare, Lyon, France.
Diabetes Ther. 2025 Mar;16(3):413-427. doi: 10.1007/s13300-024-01673-9. Epub 2024 Dec 17.
The MiniMed™ 780G system uses an advanced hybrid closed loop algorithm to improve outcomes in people with type 1 diabetes (T1D). The MiniMed™ 780G Glycemic Control and Quality of Life (EQOL) study aimed to provide routine clinical practice data on system effectiveness and associated patient-reported outcomes (PROs) in France.
Individuals aged ≥ 7 years with T1D were enrolled. A 14-day run-in phase in Manual mode preceded a 12-month study phase using Auto mode. The primary endpoint was absolute change in time in range (TIR) from baseline to 6 months. Secondary endpoints included changes in glycemic targets, glycated hemoglobin (HbA1c), and hypoglycemia. PROs included treatment satisfaction, quality of life (QoL), and fear of hypoglycemia.
Two-hundred seventy participants formed the intent-to-treat population at 6 months. TIR increased by 11.8 percentage points (standard deviation [SD] 8.96, 95% confidence interval 10.7 to 12.9, p < 0.0001), from 61.9% (SD 11.0) to 73.7% (SD 7.4), equivalent to 2.8 h per day more in range. Time < 70 mg/dL decreased by 1.5 percentage points (p < 0.0001), from 4.0% to 2.5%. All glycemic parameters significantly improved. HbA1c decreased by 0.52% and 0.42% at 6 and 12 months, respectively. More patients met glycemic targets, while severe hypoglycemia was reduced. At 12 months, treatment satisfaction increased across age groups, and QoL improved in adults. Fear of hypoglycemia decreased in adults and children.
In France, people with T1D initiating the MiniMed™ 780G system demonstrated sustained TIR and HbA1c improvements. System usage reduced hypoglycemia and fear of hypoglycemia, and increased treatment satisfaction.
ClinicalTrials.gov identifier, NCT04308291.
美敦力780G系统采用先进的混合闭环算法，以改善1型糖尿病（T1D）患者的治疗效果。美敦力780G血糖控制与生活质量（EQOL）研究旨在提供关于该系统在法国的有效性及相关患者报告结局（PROs）的常规临床实践数据。
纳入年龄≥7岁的T1D患者。在使用自动模式进行12个月的研究阶段之前，先进行为期14天的手动模式磨合阶段。主要终点是从基线到6个月时血糖达标时间（TIR）的绝对变化。次要终点包括血糖目标、糖化血红蛋白（HbA1c）和低血糖的变化。PROs包括治疗满意度、生活质量（QoL）和低血糖恐惧。
270名参与者构成了6个月时的意向性治疗人群。TIR从61.9%（标准差[SD]11.0）增加到73.7%（SD 7.4），增加了11.8个百分点（SD 8.96，95%置信区间10.7至12.9，p<0.0001），相当于每天血糖达标时间多了2.8小时。血糖<70mg/dL的时间从4.0%下降到2.5%，下降了1.5个百分点（p<0.0001）。所有血糖参数均显著改善。6个月和12个月时，HbA1c分别下降了0.52%和0.42%。更多患者达到血糖目标，同时严重低血糖减少。在12个月时，各年龄组的治疗满意度均有所提高，成人的生活质量得到改善。成人和儿童的低血糖恐惧均有所降低。
在法国，启动美敦力780G系统的T1D患者的TIR和HbA1c持续改善。系统的使用减少了低血糖和低血糖恐惧，并提高了治疗满意度。
ClinicalTrials.gov标识符，NCT04308291。
