Barnard-Kelly Katharine, Thienel Florian, Mader Julia K, Oliver Nick, Franek Edward, Vesper Iris, Dagenbach Nicole, Vogt Gerhard, Etter Tobias, Künsting Thomas
Southern Health NHS Foundation Trust, Calmore, UK.
Spotlight-AQ Ltd, Fareham, UK.
J Diabetes Sci Technol. 2024 Mar 8:19322968241234055. doi: 10.1177/19322968241234055.
The aim of this study was to compare patient-reported outcomes (PROs) in people with type 1 diabetes using either continuous subcutaneous insulin infusion (CSII) with two different insulin patch pumps or multiple daily injections (MDIs).
In this randomized three-arm study, people with type 1 diabetes on MDI therapy were included and used either MDI, the Accu-Chek Solo micropump system (Solo) or Omnipod for 26 weeks. From weeks 26 to 39, all participants used CSII with Solo. Patient-reported outcomes were assessed using the diabetes technology questionnaire (DTQ); in addition, HbA values were measured.
Overall, 181 participants were randomized (61 MDI arm, 62 Solo arm, 58 Omnipod arm) and 142 completed the study. After 26 weeks in the study, the DTQ "change" score in the Solo group (105.9 [100.6-111.2]; baseline-adjusted mean [95% confidence interval]) was significantly higher than in the MDI group (94.8 [89.6-100.0]) ( = .001). The comparison between the Solo group (105.1 [99.1-111.1]) and the Omnipod group (108.7 [103.1-114.4]) showed no significant differences ( = .382). HbA increased by 0.2% ± 0.7% in the MDI group and decreased in both pump groups (Solo group -0.2% ± 0.8% and Omnipod group -0.1% ± 0.8%). Differences in HbA between the Solo group and the MDI group were significant ( = .009), but not between the Solo group and the Omnipod group ( = .896).
This study showed that switching from MDI to CSII improves both psychosocial well-being and physiological outcomes. Furthermore, there were no substantial differences between the established and the recently released patch pump. Trial registration at www.clinicaltrials.gov is NCT03478969.
本研究旨在比较使用两种不同胰岛素贴片泵进行持续皮下胰岛素输注（CSII）或多次皮下注射（MDI）的1型糖尿病患者的患者报告结局（PROs）。
在这项随机三臂研究中，纳入接受MDI治疗的1型糖尿病患者，并让他们使用MDI、安准易泵微泵系统（Solo）或Omnipod持续26周。从第26周到第39周，所有参与者均使用Solo进行CSII治疗。使用糖尿病技术问卷（DTQ）评估患者报告结局；此外，还测量了糖化血红蛋白（HbA）值。
总体而言，181名参与者被随机分组（MDI组61人，Solo组62人，Omnipod组58人），142人完成了研究。研究26周后，Solo组的DTQ“变化”评分（105.9[100.6 - 111.2]；基线调整后均值[95%置信区间]）显著高于MDI组（94.8[89.6 - 100.0]）（P = 0.001）。Solo组（105.1[99.1 - 111.1]）与Omnipod组（108.7[103.1 - 114.4]）之间的比较未显示出显著差异（P = 0.382）。MDI组的HbA升高了0.2%±0.7%，两个泵组的HbA均下降（Solo组-0.2%±0.8%，Omnipod组-0.1%±0.8%）。Solo组与MDI组之间的HbA差异显著（P = 0.009），但Solo组与Omnipod组之间无显著差异（P = 0.896）。
本研究表明，从MDI转换为CSII可改善心理社会幸福感和生理结局。此外，已上市的和最近发布的贴片泵之间没有实质性差异。在www.clinicaltrials.gov上的试验注册号为NCT03478969。
