Kannenberg Swantje, Voggel Jenny, Thieme Nils, Witt Oliver, Pethahn Kim Lina, Schütt Morten, Sina Christian, Freckmann Guido, Schröder Torsten
Diabetes Plus, Diabetology Medical Practice, Lübeck, Germany.
Research & Development, Perfood GmbH, Lübeck, Germany.
J Diabetes Sci Technol. 2024 Jul 30:19322968241266821. doi: 10.1177/19322968241266821.
We present a digital therapeutic (DTx) using continuous glucose monitoring (CGM) and an advanced artificial intelligence (AI) algorithm to digitally personalize lifestyle interventions for people with type 2 diabetes (T2D).
A study of 118 participants with non-insulin-treated T2D (HbA ≥ 6.5%) who were already receiving standard care and had a mean baseline (BL) HbA of 7.46% (0.93) used the DTx for three months to evaluate clinical endpoints, such as HbA, body weight, quality of life and app usage, for a pre-post comparison. The study also included an assessment of initial long-term data from a second use of the DTx.
After three months of using the DTx, there was an improvement of 0.67% HbA in the complete cohort and -1.08% HbA in patients with poorly controlled diabetes (BL-HbA ≥ 7.0%) compared with standard of care ( < .001). The number of patients within the therapeutic target range (< 7.0%) increased from 38% to 60%, and 33% were on the way to remission (< 6.5%). Patients who used the DTx a second time experienced a reduction of -0.76% in their HbA levels and a mean weight loss of -6.84 kg after six months ( < .001) compared with BL.
These results indicate that the DTx has clinically relevant effects on glycemic control and weight reduction for patients with both well and poorly controlled diabetes, whether through single or repeated usage. It is a noteworthy improvement in T2D management, offering a non-pharmacological, fully digital solution that integrates biofeedback through CGM and an advanced AI algorithm.
我们提出一种数字疗法(DTx),它使用连续血糖监测(CGM)和先进的人工智能(AI)算法,为2型糖尿病(T2D)患者提供数字化的个性化生活方式干预。
一项针对118名未接受胰岛素治疗的T2D患者(糖化血红蛋白[HbA]≥6.5%)的研究,这些患者已在接受标准治疗,平均基线(BL)糖化血红蛋白为7.46%(0.93),使用该数字疗法三个月,以评估临床终点,如糖化血红蛋白、体重、生活质量和应用程序使用情况,进行前后比较。该研究还包括对第二次使用该数字疗法的初始长期数据的评估。
与标准治疗相比,使用该数字疗法三个月后,整个队列的糖化血红蛋白改善了0.67%,糖尿病控制不佳(BL-HbA≥7.0%)的患者糖化血红蛋白改善了-1.08%(P<0.001)。治疗目标范围内(<7.0%)的患者数量从38%增加到60%,33%的患者正在缓解(<6.5%)。与基线相比,第二次使用该数字疗法的患者在六个月后糖化血红蛋白水平降低了-0.76%,平均体重减轻了-6.84千克(P<0.001)。
这些结果表明,无论单次使用还是重复使用,该数字疗法对糖尿病控制良好和控制不佳的患者的血糖控制和体重减轻都具有临床相关效果。这是2型糖尿病管理方面值得注意的进步,提供了一种非药物的、完全数字化的解决方案,通过连续血糖监测和先进的人工智能算法整合生物反馈。