Abstract：
UNASSIGNED: In a randomized controlled trial, the efficacy of a digital diabetes diary regarding a reduction of diabetes distress was evaluated.
UNASSIGNED: A randomized controlled trial with a 12-week follow-up was conducted in 41 study sites across Germany. Key eligibility criteria were a diagnosis of type 1, type 2, or gestational diabetes and regular self-monitoring of blood glucose. Participants were randomly assigned (2:1 ratio) to either use the digital diabetes logbook (mySugr PRO), or to the control group without app use. The primary outcome was the reduction in diabetes distress at the 12-week follow-up. All analyses were based on the intention-to-treat population with all randomized participants. The trial was registered at the German Register for Clinical Studies (DRKS00022923).
UNASSIGNED: Between February 11, 2021, and June 24, 2022, 424 participants (50% female, 50% male) were included, with 282 being randomized to the intervention group (66.5%) and 142 to the control group (33.5%). A total of 397 participants completed the trial (drop-out rate: 6.4%). The median reduction in diabetes distress was 2.41 (interquartile range [IQR]: -2.50 to 8.11) in the intervention group and 1.25 (IQR: -5.00 to 7.50) in the control group. The model-based adjusted between-group difference was significant (-2.20, IQR: -4.02 to -0.38, P = .0182) favoring the intervention group. There were 27 adverse events, 17 (6.0%) in the intervention group, and 10 (7.0%) in the control group.
UNASSIGNED: The efficacy of the digital diabetes logbook was demonstrated regarding improvements in mental health in people with type 1, type 2, and gestational diabetes.
UNASSIGNED: A randomized controlled trial with a 12-week follow-up was conducted in 41 study sites across Germany. Key eligibility criteria were a diagnosis of type 1, type 2, or gestational diabetes and regular self-monitoring of blood glucose. Participants were randomly assigned (2:1 ratio) to either use the digital diabetes logbook (mySugr PRO), or to the control group without app use. The primary outcome was the reduction in diabetes distress at the 12-week follow-up. All analyses were based on the intention-to-treat population with all randomized participants. The trial was registered at the German Register for Clinical Studies (DRKS00022923).
UNASSIGNED: Between February 11, 2021, and June 24, 2022, 424 participants (50% female, 50% male) were included, with 282 being randomized to the intervention group (66.5%) and 142 to the control group (33.5%). A total of 397 participants completed the trial (drop-out rate: 6.4%). The median reduction in diabetes distress was 2.41 (interquartile range [IQR]: -2.50 to 8.11) in the intervention group and 1.25 (IQR: -5.00 to 7.50) in the control group. The model-based adjusted between-group difference was significant (-2.20, IQR: -4.02 to -0.38, P = .0182) favoring the intervention group. There were 27 adverse events, 17 (6.0%) in the intervention group, and 10 (7.0%) in the control group.
UNASSIGNED: The efficacy of the digital diabetes logbook was demonstrated regarding improvements in mental health in people with type 1, type 2, and gestational diabetes.
摘要：
■在一项随机对照试验中，评估了数字糖尿病日记在减少糖尿病困扰方面的疗效.
■一项为期12周随访的随机对照试验在德国41个研究中心进行。关键的合格标准是诊断为1型，2型或妊娠期糖尿病，并定期自我监测血糖。参与者被随机分配（2：1比例）使用数字糖尿病日志（mySugrPRO），或不使用应用程序的控制组。主要结果是12周随访时糖尿病困扰的减少。所有分析均基于所有随机参与者的意向治疗人群。该试验在德国临床研究注册中心（DRKS00022923）注册。
■在2021年2月11日至2022年6月24日之间，424名参与者（50％为女性，包括50％的男性），282人被随机分配到干预组（66.5％），142人被随机分配到对照组（33.5％）。共有397名参与者完成了试验（辍学率：6.4%）。干预组糖尿病困扰的中位数减少为2.41（四分位距[IQR]：-2.50至8.11），对照组为1.25（IQR：-5.00至7.50）。基于模型的校正组间差异显著(-2.20,IQR:-4.02至-0.38,P=.0182)有利于干预组。有27个不良事件，干预组17人（6.0%），对照组10例(7.0%)。
■数字糖尿病日志在改善1型、2型和妊娠糖尿病患者心理健康方面的功效得到了证明。
■一项为期12周随访的随机对照试验在德国41个研究中心进行。关键的合格标准是诊断为1型，2型或妊娠期糖尿病，并定期自我监测血糖。参与者被随机分配（2：1比例）使用数字糖尿病日志（mySugrPRO），或不使用应用程序的控制组。主要结果是12周随访时糖尿病困扰的减少。所有分析均基于所有随机参与者的意向治疗人群。该试验在德国临床研究注册中心（DRKS00022923）注册。
■在2021年2月11日至2022年6月24日之间，424名参与者（50％为女性，包括50％的男性），282人被随机分配到干预组（66.5％），142人被随机分配到对照组（33.5％）。共有397名参与者完成了试验（辍学率：6.4%）。干预组糖尿病困扰的中位数减少为2.41（四分位距[IQR]：-2.50至8.11），对照组为1.25（IQR：-5.00至7.50）。基于模型的校正组间差异显著(-2.20,IQR:-4.02至-0.38,P=.0182)有利于干预组。有27个不良事件，干预组17人（6.0%），对照组10例(7.0%)。
■数字糖尿病日志在改善1型、2型和妊娠糖尿病患者心理健康方面的功效得到了证明。
