患者偏好的（每日1单位）与ADA/EASD指南推荐的（每3天2单位）基础胰岛素滴定算法的疗效和依从性比较：多中心、随机、临床研究。
Comparison of Efficacy and Adherence of Patient-Preferred (1 Unit Daily) and ADA/EASD Guideline-Recommended (2 Units Every 3 Days) Basal Insulin Titration Algorithms: Multicenter, Randomized, Clinical Study.
作者信息
Li Ling, Zhang Xiaodan, Zhang Tong, Zeng Liankun, Lin Mingrun, Li Yanli, Li Wangen
机构信息
Department of Endocrinology, The Second Affiliated Hospital, Guangzhou Medical University, Guangzhou, People's Republic of China.
Department of Endocrinology, The Third Affiliated Hospital, Southern Medical University, Guangzhou, People's Republic of China.
出版信息
Patient Prefer Adherence. 2024 Mar 18;18:687-694. doi: 10.2147/PPA.S446855. eCollection 2024.
AIM
Insulin titration often faces inertia, hindering glycemic control. A patient-centered approach empowers patients to overcome this inertia. This study aims to compare the effectiveness of patient-preferred and guideline-recommended self-titration algorithms in achieving glycemic targets and improving adherence.
METHODS
Outpatients with type 2 diabetes (T2D) who did not respond to oral antihyperglycemic drugs (OAD) were assessed. They were randomly assigned to patient-preferred and guideline-recommended groups. In the patient-preferred group, individuals selected an algorithm to self-adjust their insulin glargine dosage by 2 units every 3 days if the mean fasting blood glucose (FBG) over the past 3 consecutive days was ≥7.0 mmol/L, or by 1 unit daily if the FBG on the same day was ≥7.0 mmol/L. In the guideline-recommended group, insulin glargine was titrated by 2 units every 3 days if the mean FBG over the past 3 consecutive days was ≥7.0 mmol/L. The FBG target was set below <7.0 mmol/L.
RESULTS
Thirty-nine participants in the patient-preferred group and 42 in the guideline-recommended group completed the study. The cumulative rates of achieving the FBG target in the patient-preferred group compared to the guideline-recommended group were 69.2% vs 54.8% (²=1.792, p=0.181) in week 1, 89.7% vs 73.8% (²=3.403, p = 0.065) in week 2, 94.9% vs 76.2% (²=17.638, p=0.000) in week 3, and 100.0% vs 88.1% (²=4.405, p=0.036) in week 4. Adherence rates were significantly higher in the patient-preferred group (97.4%, 37/38) compared to the guideline-recommended group (66.7%, 28/42) (²=12.688, p=0.000). Insulin glargine dosage at FBG target achievement was 21.2±4.3 U in the patient-preferred group and 18.8±6.7 U in the guideline-recommended group (t=1.888, p=0.063). Hypoglycemia was reported in 1 patient in the guideline-recommended group, with no instances in the patient-preferred group.
CONCLUSION
The patient-preferred self-titration algorithm demonstrates a higher rate of reaching glucose targets and improved adherence.
TRIAL REGISTRATION NUMBER
ChiCTR2100050805.
目的
胰岛素滴定常常面临惰性，这阻碍了血糖控制。以患者为中心的方法能使患者克服这种惰性。本研究旨在比较患者偏好的和指南推荐的自我滴定算法在实现血糖目标及提高依从性方面的有效性。
方法
对口服降糖药（OAD）治疗无效的2型糖尿病（T2D）门诊患者进行评估。他们被随机分为患者偏好组和指南推荐组。在患者偏好组中，如果过去连续3天的平均空腹血糖（FBG）≥7.0 mmol/L，个体选择一种算法，每3天将甘精胰岛素剂量自行调整2单位；如果当天FBG≥7.0 mmol/L，则每天自行调整1单位。在指南推荐组中，如果过去连续3天的平均FBG≥7.0 mmol/L，每3天将甘精胰岛素滴定2单位。FBG目标设定为低于<7.0 mmol/L。
结果
患者偏好组39名参与者和指南推荐组42名参与者完成了研究。在第1周，患者偏好组与指南推荐组实现FBG目标的累积率分别为69.2%对54.8%（²=1.792，p=0.181）；在第2周，分别为89.7%对73.8%（²=3.403，p = 0.065）；在第3周，分别为94.9%对76.2%（²=17.638，p=0.000）；在第4周，分别为100.0%对88.1%（²=4.405，p=0.036）。患者偏好组的依从率（97.4%，37/38）显著高于指南推荐组（66.7%，2 /42）（²=12.688，p=0.000）。达到FBG目标时，患者偏好组的甘精胰岛素剂量为21.2±4.3 U，指南推荐组为18.8±6.7 U（t=1.888，p=0.063）。指南推荐组有1例患者报告发生低血糖，患者偏好组无此情况。
结论
患者偏好的自我滴定算法实现血糖目标的比率更高，且依从性更好。
试验注册号
ChiCTR2100050805。
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