AIMS Although conventional interventions for people at high risk of developing type 2 diabetes are usually conducted face-to-face, such interventions are burdensome for healthcare providers. We developed a lifestyle intervention program combining lifestyle coaching via a smartphone application augmented by intermittently scanned continuous glucose monitoring (isCGM) without burdening healthcare providers. Its effectiveness for glycemic control and body weight reduction in people at risk of type 2 diabetes was investigated. MATERIALS AND METHODS For this 12-week randomized unblinded trial with offline recruitment, participants with HbA1c 5.6-6.4% or fasting blood glucose 110-125 mg/dl and body mass index (BMI) > 23 kg/m2 but <40 kg/m2 were randomly assigned to the Intervention group (App) and Control group (C). Primary endpoint was the difference in time in range (TIR) of blood glucose 70-140 mg/dL (3.9-7.8 mmol/L) before and after the study period between the two groups. RESULTS Among 168 patients (mean age 48.1 y, mean BMI 26.6 kg/m2, and male 80.4%), 82 and 86 were assigned to the App group and C group, respectively. After 12 weeks, TIR of blood glucose 70-140 mg/dL significantly improved in the App group compared to the C group (-2.6 min/day vs. + 31.5 min/day, p = 0.03). Changes in time above range did not differ, whereas time below range (blood glucose <70 mg/dL;  + 23.5 min/day vs. -8.9 min/day, p = 0.02) improved in the App group. BMI (-0.26 vs. -0.59, p = 0.017) was reduced in the App group compared to the C group. CONCLUSION Intervention with a smartphone app and isCGM increased glycemic control accompanied by decreased carbohydrate intake and weight loss. Further trials are needed to confirm whether these interventions can reduce incident type 2 diabetes.

中文翻译：

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“利用智能手机应用程序和 isCGM 对 2 型糖尿病高危人群进行生活方式干预：随机试验”。

目的 虽然针对 2 型糖尿病高风险人群的常规干预措施通常是面对面进行的，但此类干预措施对医疗保健提供者来说是负担。我们开发了一种生活方式干预计划，通过智能手机应用程序结合生活方式指导，并通过间歇扫描连续血糖监测 (isCGM) 进行增强，而不会给医疗保健提供者带来负担。研究了其对有 2 型糖尿病风险的人群控制血糖和减轻体重的有效性。材料和方法 在这项为期 12 周的离线随机非盲试验中，参与者的 HbA1c 为 5.6-6.4% 或空腹血糖为 110-125 mg/dl，体重指数 (BMI) > 23 kg/m2 但 <40 kg/m2随机分为干预组（App）和对照组（C）。主要终点是两组研究前后血糖70-140 mg/dL (3.9-7.8 mmol/L)的时间范围(TIR)差异。结果 168 名患者（平均年龄 48.1 岁，平均 BMI 26.6 kg/m2，男性 80.4%）中，分别有 82 名和 86 名被分配到 App 组和 C 组。12 周后，与 C 组相比，App 组血糖 70-140 mg/dL 的 TIR 显着改善（-2.6 分钟/天 vs. + 31.5 分钟/天，p = 0.03）。App 组中高于范围的时间变化没有差异，而低于范围的时间（血糖 <70 mg/dL；+ 23.5 分钟/天 vs. -8.9 分钟/天，p = 0.02）有所改善。与 C 组相比，App 组的 BMI（-0.26 与 -0.59，p = 0.017）降低。结论 使用智能手机应用程序和 isCGM 进行干预可增强血糖控制，同时减少碳水化合物摄入量并减轻体重。需要进一步的试验来确认这些干预措施是否可以减少 2 型糖尿病的发生。