Dwibedi Chinmay, Abrahamsson Birgitta, Rosengren Anders H
Department of Neuroscience and Physiology, Sahlgrenska Academy at the University of Gothenburg, Medicinaregatan 11, 40530, Gothenburg, Sweden.
Wallenberg Centre for Molecular and Translational Medicine, University of Gothenburg, Gothenburg, Sweden.
Diabetes Ther. 2022 Mar;13(3):423-439. doi: 10.1007/s13300-022-01214-2. Epub 2022 Feb 12.
The lack of effective, scalable solutions for lifestyle treatment is a global clinical problem, causing severe morbidity and mortality. Digital tools could enable broad utility, but long-term metabolic outcomes and the influence on quality of life are unclear.
We developed a new method for lifestyle treatment that promotes self-reflection and iterative behavioural change, provided as a digital tool, and evaluated its effect on glycaemic control in patients with type 2 diabetes with HbA1c below 52 mmol/mol (n = 297). As a secondary analysis, its effect on quality of life (using SF-12) was examined in both participants with and without diabetes (total n = 1914). The tool was evaluated during a 12-week randomization period to assess the existence of effect, with a subsequent open-label follow-up to study long-term outcomes.
Participants were randomized to wait or access the intervention tool. The mean difference in HbA1c was 2 mmol/mol (95% CI - 4 to 0; P = 0.02) after 12 weeks in participants with type 2 diabetes. The groups were then merged to enable all participants to use the tool. The mean HbA1c reduction from baseline in patients with type 2 diabetes using the tool was 2 mmol/mol compared with matched controls (95% CI - 3 to 0; P = 0.005). In users with HbA1c above 45 mmol/mol, the mean difference between the groups was 4 mmol/mol (95% CI - 7 to - 2). The improvements were sustained during the follow-up of 1 year on average. Users of the tool also had improved quality of life from baseline to 6 months, mainly observed in non-diabetic participants.
The tool does not require in-person reinforcement or increased healthcare resources, and the marginal cost is fundamentally lower than pharmacological treatment and most existing lifestyle interventions. The results therefore open a new means for self-managed lifestyle treatment with long-term metabolic efficacy that can benefit large numbers of people.
ClinicalTrials.gov NCT04624321 and NCT05006508.
缺乏有效、可扩展的生活方式治疗方案是一个全球性的临床问题，会导致严重的发病率和死亡率。数字工具可能具有广泛的实用性，但长期代谢结果以及对生活质量的影响尚不清楚。
我们开发了一种新的生活方式治疗方法，该方法促进自我反思和迭代行为改变，并作为一种数字工具提供。我们评估了其对糖化血红蛋白（HbA1c）低于52 mmol/mol的2型糖尿病患者血糖控制的影响（n = 297）。作为一项次要分析，我们在有糖尿病和无糖尿病的参与者中（总计n = 1914）研究了其对生活质量（使用SF - 12）的影响。在为期12周的随机分组期间对该工具进行评估以评估效果的存在情况，随后进行开放标签随访以研究长期结果。
参与者被随机分为等待组或使用干预工具组。2型糖尿病参与者在12周后HbA1c的平均差异为2 mmol/mol（95%CI - 4至0；P = 0.02）。然后将两组合并，使所有参与者都能使用该工具。与匹配的对照组相比，使用该工具的2型糖尿病患者HbA1c从基线的平均降低值为2 mmol/mol（95%CI - 3至0；P = 0.005）。在HbA1c高于45 mmol/mol的使用者中，两组之间的平均差异为4 mmol/mol（95%CI - 7至 - 2）。这些改善在平均1年的随访期间得以持续。该工具的使用者从基线到6个月时生活质量也有所改善，主要在非糖尿病参与者中观察到。
该工具不需要亲自强化或增加医疗资源，边际成本从根本上低于药物治疗和大多数现有的生活方式干预措施。因此，这些结果为具有长期代谢疗效的自我管理生活方式治疗开辟了一种新方法，可使大量人群受益。
ClinicalTrials.gov NCT04624321和NCT05006508。
