A digital health application (DiGA) has been shown to relieve the distress that patients can experience when managing diabetes, which can compromise their care, in a randomised clinical trial.

在一项随机临床试验中，数字健康应用（DiGA）已被证明可以缓解患者在管理糖尿病时可能遇到的痛苦，这可能会影响他们的护理。

Diabetes distress is an emotional reaction specific to the demands of diabetes and diabetes therapy – leading to feelings of hopelessness, discouragement and exhaustion – which is not necessarily pathological but can become so if present at an elevated level, according to study investigator Dominic Ehrmann of the FIDAM diabetes research institute in Germany..

德国FIDAM糖尿病研究所的Dominic Ehrmann研究人员表示，糖尿病困扰是一种情绪反应，特定于糖尿病和糖尿病治疗的需求-导致绝望，沮丧和疲惫的感觉-这不一定是病理性的，但如果出现在高水平，可能会变得如此。。

He told the EASD meeting this week that it is clinically relevant to monitor diabetes distress as high levels have been linked to a risk of depression, poorer quality-of-life, and suboptimal management of diabetes that can worsen blood glucose control, as measured by higher haemoglobin A1c levels. It is estimated that around 35% of patients with type 1 and type 2 diabetes have elevated distress levels..

他告诉本周的EASD会议，监测糖尿病困扰具有临床意义，因为高水平与抑郁症风险，较差的生活质量以及可能恶化血糖控制的糖尿病管理不理想有关，血红蛋白A1c水平较高。据估计，约35%的1型和2型糖尿病患者的窘迫水平升高。。

DiGAs can relieve distress in several ways, for example by providing a simple overview of glucose control, making data easier to interpret, and providing motivational feedback and positive reinforcement when goals are achieved, said Ehrmann.

Ehrmann说，DiGAs可以通过几种方式缓解痛苦，例如通过提供葡萄糖控制的简单概述，使数据更容易解释，并在实现目标时提供激励反馈和积极强化。

The new trial investigated the role of the Pro version of the mySugr app, a digital diabetes logbook which Roche acquired along with its developer in 2017 and – in a defining moment for digital health within pharma – positioned it at the heart of its diabetes management ecosystem alongside products like its Accu-Chek blood glucose testing range..

这项新的试验调查了mySugr应用程序的专业版本的作用，这是罗氏在2017年与其开发者一起收购的数字糖尿病日志，并且-在制药公司数字健康的决定性时刻-将其定位于其糖尿病管理生态系统的核心与Accu-Chek血糖测试范围等产品一起。。

The study was specifically designed to test the effects of the app on diabetes distress, the primary endpoint, with the app compared to no digital intervention and patients followed up after 12 weeks. It included nearly 400 evaluable patients with type 1 and 2 as well as gestational diabetes who were asked to carry out daily blood glucose measurements and input the results into the app..

该研究专门用于测试app对糖尿病困扰（主要终点）的影响，app与无数字干预和12周后随访的患者相比。它包括近400名可评估的1型和2型患者以及妊娠糖尿病患者，他们被要求进行每日血糖测量并将结果输入应用程序。。

Diabetes distress was assessed using a standard patient-reported outcome (PRO) questionnaire called PAID, with various secondary measures including Hba1C to give an indication of blood glucose control.

使用称为PAID的标准患者报告结果（PRO）问卷评估糖尿病困扰，并采用各种次要措施（包括Hba1C）来指示血糖控制。

There was an improvement in diabetes distress with mySugr Pro – a reduction of around 3.6 on the PAID scale versus a slight increase in the control group – which met the threshold for statistical significance with a p-value of 0.0182.

mySugr Pro改善了糖尿病困扰-PAID量表减少了约3.6，而对照组略有增加-达到了统计学显着性阈值，p值为0.0182。

There were no significant improvements on secondary endpoints in the study, including HbA1c, although Ehrmann noted there were 80 women with gestational diabetes who might not be expected to see a significant change in the biomarker over the course of the study.

研究中的次要终点没有显着改善，包括HbA1c，尽管Ehrmann指出有80名患有妊娠糖尿病的女性在研究过程中可能不会看到生物标志物的显着变化。

If only type 1 and type 2 patients were assessed, there was a 2.2 higher chance of achieving a target Hba1c level of 6.5% or lower, along with evidence for lower rates of very high or very low blood sugar, which provided some evidence of improved glycaemic control.

如果仅评估1型和2型患者，则达到6.5%或更低的目标Hba1c水平的机会高2.2倍，同时证据显示非常高或非常低的血糖率较低，这提供了一些改善的证据血糖控制。

There was also a high degree of patient satisfaction with the app, with a very low drop-out rate of 6.4 – unusual for studies of digital interventions - backed up by user data which showed that it was used as directed on 93% of days overall.

患者对该应用程序的满意度也很高，辍学率非常低，为6.4-数字干预研究不常见-由用户数据支持，这表明它被用于整体93%的天数。

“We hope that we can now go all the way to making the mySugr Pro app a prescribable digital health application in Germany,” said Ehrmann.

Ehrmann说：“我们希望我们现在能够一直在使mySugr Pro应用程序成为德国可开处方的数字健康应用程序。”。

There is a well-defined framework for approval and reimbursement of DiGAs in Germany, where there are 55 prescribable products on the market including five in the metabolic disease area, including apps to support lifestyle changes, manage obesity and help patients deal with depression caused by diabetes..

德国有一个明确的DiGAs批准和报销框架，市场上有55种可处方产品，其中包括代谢疾病领域的5种，包括支持生活方式改变，管理肥胖和帮助患者治疗抑郁症的应用。由糖尿病引起。。

In the first nine months of 2022, the latest period for which data is available, there were more than 200,000 prescriptions for DiGA products, out of which around 80% (164,000) were redeemed.

在2022年的前9个月，即可获得数据的最新时期，DiGA产品的处方超过200000张，其中约80%（164000）被赎回。

Around 31,000 of those were for diabetes-related apps at a cost of roughly €15 million to the German healthcare system, out of total spending on DiGAs of €55 million since the law was enacted.

其中约有31000个用于糖尿病相关应用程序，德国医疗保健系统的费用约为1500万欧元，自法律颁布以来，DiGAs总支出为5500万欧元。

mySugr Pro is aiming to plug a gap in the category with its focus on diabetes self-management and glucose control, said Ehrmann.

Ehrmann说，mySugr Pro旨在填补这一类别的空白，专注于糖尿病自我管理和血糖控制。