Brown Sue A, Laffel Lori M, Akturk Halis K, Forlenza Gregory P, Shah Viral N, Wadwa R Paul, Cobry Erin C, Isganaitis Elvira, Schoelwer Melissa, Lu Virginia S, Rueda Ricardo, Sherer Nicholas, Corbett John P, Sasson-Katchalski Ravid, Pinsker Jordan E
Division of Endocrinology, Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia, USA.
Research Division, Joslin Diabetes Center and Department of Pediatrics, Harvard Medical School, Boston, Massachusetts, USA.
Diabetes Technol Ther. 2025 Mar;27(3):187-193. doi: 10.1089/dia.2024.0501. Epub 2024 Nov 26.
We evaluated a modified version of Control-IQ technology with a lower treatment range and a modified meal bolus module in adults, adolescents, children, and preschoolers with type 1 diabetes in a multicenter, randomized, and crossover trial. After a 2-week run-in with Control-IQ technology v1.5, the modified system was evaluated for 2 weeks using treatment range of 112.5-160 mg/dL (standard range [SR]), and for 2 weeks using lower treatment range of 90-130 mg/dL (lower range, LR), at home in random order. Two late bolus meal challenges were performed in each 2-week period, bolusing 45 min after meals with and without a new late bolus feature. Overall, 72 participants aged 3-57 years completed the study. There were no diabetic ketoacidosis or severe hypoglycemia events. All meal challenges were completed safely. Time in range (TIR) 70-180 mg/dL improved the most with LR to 68.0% (+3.1%, < 0.001, for LR vs. run-in and +2.1%, < 0.001, for LR vs. SR). Similar improvements were observed for time in tight range (TITR) 70-140 mg/dL (+3.3%, < 0.001, for LR vs. run-in and +4.0%, < 0.001, for LR vs. SR), time >180 mg/dL, and mean glucose. Participants with lower baseline hemoglobin A1c (HbA1c) achieved the highest TIR and TITR with LR use, while the greatest improvements in TIR and TITR were evident in those with higher baseline HbA1c. The lower treatment range and late bolus feature of the modified Control-IQ system were safe for use in all age-groups. TIR and TITR improved with LR regardless of baseline HbA1c.
在一项多中心、随机、交叉试验中，我们对1型糖尿病成人、青少年、儿童和学龄前儿童使用了治疗范围更低的改良版Control-IQ技术以及改良后的餐时大剂量模块。在使用Control-IQ技术v1.5进行2周导入期后，在家中以随机顺序对改良系统进行评估，使用112.5-160mg/dL的治疗范围（标准范围[SR]）评估2周，使用90-130mg/dL的更低治疗范围（更低范围，LR）评估2周。在每个2周期间进行两次延迟大剂量餐食挑战，在有和没有新的延迟大剂量功能的情况下，餐后45分钟给予大剂量。总体而言，72名年龄在3至57岁的参与者完成了研究。没有糖尿病酮症酸中毒或严重低血糖事件。所有餐食挑战均安全完成。血糖在70-180mg/dL范围内的时间（TIR）在使用更低范围时改善最为明显，达到68.0%（与导入期相比增加3.1%，P<0.001，与标准范围相比增加2.1%，P<0.001）。血糖在70-140mg/dL的严格范围内的时间（TITR）、血糖>180mg/dL的时间以及平均血糖也有类似改善（与导入期相比，LR组TITR增加3.3%，P<0.001，与标准范围相比增加4.0%，P<0.001）。基线糖化血红蛋白（HbA1c）较低的参与者在使用更低范围时TIR和TITR最高，而TIR和TITR改善最大的是基线HbA1c较高的参与者。改良版Control-IQ系统的更低治疗范围和延迟大剂量功能在所有年龄组中使用都是安全的。无论基线HbA1c如何，使用更低范围时TIR和TITR均有所改善。
