《在斋月期间使用 fasting algorithm for singaporeans with type 2 diabetes（fast）治疗新加坡 2 型糖尿病患者的疗效和安全性：一项前瞻性、多中心、随机对照试验》。
Efficacy and Safety of Use of the Fasting Algorithm for Singaporeans With Type 2 Diabetes (FAST) During Ramadan: A Prospective, Multicenter, Randomized Controlled Trial.
机构信息
Department of Pharmacy, Faculty of Science, National University of Singapore.
Department of Pharmacy, Tan Tock Seng Hospital, Singapore.
出版信息
Ann Fam Med. 2020 Mar;18(2):139-147. doi: 10.1370/afm.2500.
PURPOSE
We aimed to evaluate the efficacy and safety of use of the Fasting Algorithm for Singaporeans with Type 2 Diabetes (FAST) during Ramadan.
METHODS
We performed a prospective, multicenter, randomized controlled trial. The inclusion criteria were age ≥21 years, baseline glycated hemoglobin (HbA) level ≤9.5%, and intention to fast for ≥10 days during Ramadan. Exclusion criteria included baseline estimated glomerular filtration rate <30 mL/min, diabetes-related hospitalization, and short-term corticosteroid therapy. Participants were randomized to intervention (use of FAST) or control (usual care without FAST) groups. Efficacy outcomes were HbA level and fasting blood glucose and postprandial glucose changes, and the safety outcome was incidence of major or minor hypoglycemia during the Ramadan period. Glycemic variability and diabetes distress were also investigated. Linear mixed models were constructed to assess changes.
RESULTS
A total of 97 participants were randomized (intervention: n = 46, control: n = 51). The HbA improvement during Ramadan was 4 times greater in the intervention group (-0.4%) than in the control group (-0.1%) ( = .049). The mean fasting blood glucose level decreased in the intervention group (-3.6 mg/dL) and increased in the control group (+20.9 mg/dL) ( = .034). The mean postprandial glucose level showed greater improvement in the intervention group (-16.4 mg/dL) compared to the control group (-2.3 mg/dL). There were more minor hypoglycemic events based on self-monitered blood glucose readings in the control group (intervention: 4, control: 6; = .744). Glycemic variability was not significantly different between the 2 groups ( = .284). No between-group differences in diabetes distress were observed ( = .479).
CONCLUSIONS
Our findings emphasize the importance of efficacious, safe, and culturally tailored epistemic tools for diabetes management.
目的
我们旨在评估在斋月期间使用新加坡 2 型糖尿病禁食算法（FAST）的疗效和安全性。
方法
我们进行了一项前瞻性、多中心、随机对照试验。纳入标准为年龄≥21 岁，基线糖化血红蛋白（HbA）水平≤9.5%，并打算在斋月期间禁食≥10 天。排除标准包括基线估算肾小球滤过率<30 mL/min、糖尿病相关住院治疗和短期皮质类固醇治疗。参与者被随机分配到干预（使用 FAST）或对照组（不使用 FAST 的常规护理）。主要疗效终点为 HbA 水平和空腹血糖及餐后血糖变化，安全性终点为斋月期间主要或次要低血糖的发生率。还研究了血糖变异性和糖尿病困扰。采用线性混合模型评估变化。
结果
共有 97 名参与者被随机分配（干预组：n=46，对照组：n=51）。干预组在斋月期间的 HbA 改善幅度（-0.4%）是对照组的 4 倍（-0.1%）（=0.049）。干预组的空腹血糖水平下降（-3.6 mg/dL），对照组升高（+20.9 mg/dL）（=0.034）。干预组餐后血糖水平改善幅度较大（-16.4 mg/dL），对照组为（-2.3 mg/dL）。根据自我监测血糖读数，对照组发生的轻微低血糖事件更多（干预组：4 例，对照组：6 例；=0.744）。两组间血糖变异性无显著差异（=0.284）。未观察到两组间糖尿病困扰存在差异（=0.479）。
结论
我们的研究结果强调了针对糖尿病管理的有效、安全和文化适应性认知工具的重要性。
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