Chawla Rajeev, Jaggi Shalini, Gupta Amit, Bantwal Ganapathi, Patil Suhas
North Delhi Diabetes Centre, Delhi, India.
Lifecare Diabetes Centre, Delhi, India.
JMIR Diabetes. 2022 Oct 31;7(4):e41401. doi: 10.2196/41401.
Patients with type 2 diabetes mellitus (T2DM) having elevated levels of blood glucose and glycated hemoglobin (HbA) are at higher risk of macro- and microvascular complications. Nonetheless, the goal of achieving glycemic control cannot be met with the use of pharmacotherapy alone. The recent emergence of digital therapeutic tools has shown the possibility of improving the modifiable risk factors and self-management of diabetes.
The aim of this study was to examine the clinical utility of a digital therapeutic intervention as an add-on therapy to achieve glycemic control in patients with T2DM.
This was a 12-week prospective, single-arm digital intervention study in patients with T2DM receiving regular antidiabetic treatment. The eligibility criteria included male and female patients with HbA≥6.5%, functional English literacy, and a mobile phone capable of running the intervention app. Outcome measures of the study were mean changes in HbA, fasting blood glucose (FBG), postprandial blood glucose (PPBG), BMI, and Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) index at the end of 12 weeks.
A total of 128 participants completed the study period of 12 weeks. There were 54.7% (70/128) men and 45.3% (58/128) women with a mean age of 48.48 years (SD 10.27). At the end of 12 weeks, the mean change in HbA, FBG, PPBG, and BMI for the overall study population was -0.84% (P<.001), -8.39 mg/dl (P=.02), -14.97 mg/dl (P<.001), and -0.24 kg/m (P=.06), respectively. Among the participants showing improvement in the HbA value at the end of 12 weeks (responders), the mean change in HbA, FBG, PPBG, and BMI was -1.24% (P<.001), -12.42 mg/dl (P=.003), -21.45 mg/dl (P<.001), and -0.34 kg/m (P=.007), respectively. There was an increase in HOMA-IR values for the overall study population (0.54, P=.29). HbA response showed a significant association with a baseline HbA level ≥7.5%, no prior history of smoking, and no prior COVID-19 infection, as well as with higher levels of program engagement.
A digital therapeutic intervention when used alongside standard medications significantly reduces HbA, FBG, and PPBG levels in patients with T2DM.
2型糖尿病（T2DM）患者血糖和糖化血红蛋白（HbA）水平升高，发生大血管和微血管并发症的风险更高。然而，仅使用药物治疗无法实现血糖控制目标。近年来出现的数字治疗工具显示出改善糖尿病可改变风险因素和自我管理的可能性。
本研究旨在探讨数字治疗干预作为辅助治疗手段在T2DM患者中实现血糖控制的临床效用。
这是一项为期12周的前瞻性单臂数字干预研究，研究对象为接受常规抗糖尿病治疗的T2DM患者。纳入标准包括HbA≥6.5%的男性和女性患者、具备实用英语读写能力以及拥有可运行干预应用程序的手机。研究的结局指标为12周结束时HbA、空腹血糖（FBG）、餐后血糖（PPBG）、体重指数（BMI）和胰岛素抵抗稳态模型评估（HOMA-IR）指数的平均变化。
共有128名参与者完成了12周的研究期。男性占54.7%（70/128），女性占45.3%（58/128），平均年龄为48.48岁（标准差10.27）。12周结束时，整个研究人群的HbA、FBG、PPBG和BMI的平均变化分别为-0.84%（P<0.001）、-8.39mg/dl（P=0.02）、-14.97mg/dl（P<0.001）和-0.24kg/m²（P=0.06）。在12周结束时HbA值有所改善的参与者（反应者）中，HbA、FBG、PPBG和BMI的平均变化分别为-1.24%（P<0.001）、-12.42mg/dl（P=0.003）、-21.45mg/dl（P<0.001）和-0.34kg/m²（P=0.007）。整个研究人群的HOMA-IR值有所增加（0.54，P=0.29）。HbA反应与基线HbA水平≥7.5%、无吸烟史、无新冠病毒感染史以及更高的项目参与度显著相关。
数字治疗干预与标准药物联合使用时，可显著降低T2DM患者的HbA、FBG和PPBG水平。
