Efficacy of the digital therapeutic glucura combined with CGM in the treatment of type 2 diabetes: a randomised controlled trial over 6 months

IF 10.4 1区医学 Q1 ENDOCRINOLOGY & METABOLISM

Diabetologia Pub Date : 2026-10-01 DOI:10.1007/s00125-026-06880-6

Guido Freckmann,Inke R. König,Hanna Grube,Maren Vens,Oliver Witt,Vanessa Kappelmeier,Kim L. Pethahn,Christian Sina,Othmar Moser,Torsten Schröder

{"title":"Efficacy of the digital therapeutic glucura combined with CGM in the treatment of type 2 diabetes: a randomised controlled trial over 6 months","authors":"Guido Freckmann,Inke R. König,Hanna Grube,Maren Vens,Oliver Witt,Vanessa Kappelmeier,Kim L. Pethahn,Christian Sina,Othmar Moser,Torsten Schröder","doi":"10.1007/s00125-026-06880-6","DOIUrl":null,"url":null,"abstract":"Abstract Aims/hypothesis CGM is increasingly recommended for non-insulin-treated type 2 diabetes according to the ADA Standards of Care 2026. However, its clinical benefit in high-quality standard care remains limited. This study evaluated whether addition of the digital therapeutic glucura, which delivers personalised lifestyle intervention and self-management guidance, improves glycaemic outcomes beyond CGM and standard care. Methods The study was a 6-month, multicentre, open-label RCT conducted at 24 sites in Germany (ID: DRKS00032537). Adults (≥18 years) with non-insulin-treated type 2 diabetes (HbA 1c 53–97 mmol/mol [7.0–11.0%], BMI≥25 kg/m 2 ) receiving standard care were randomly assigned (1:1) by centralised stratified block randomisation to glucura or a control app. Participants and study personnel were not masked to group assignment. Both groups used intermittent CGM every 3 months during the study. CGM sensors were not used prior to the study. The primary endpoint was the change in HbA 1c from baseline to 6 months. Secondary outcomes included weight change and patient-centric measures. Results Of 327 randomised participants (intervention: n =165; control: n =162), 320 were analysed (ITT population). The standalone CGM control group improved HbA 1c levels by 3.3 mmol/mol (0.30 percentage points); however, the intervention group showed greater reductions of 8.7 mmol/mol (0.80 percentage points) with an adjusted difference of –5 mmol/mol (−0.46 percentage points; 95% CI −7, −3 mmol/mol; p =0.00003). Within the intervention group, more participants achieved HbA 1c targets (<53 mmol/mol [<7.0%]: 55% vs 31%, OR 3.38, exploratory p =0.0002; <48 mmol/mol [<6.5%]: 27% vs 7%, OR 6.63, exploratory p =0.0001). The mean weight loss was also greater in the intervention group (4.11% vs 1.79%, p <0.0001). Significant improvements in mental health and diabetes-related distress were also observed. The positive effects were consistent across all subgroups. No device-related serious adverse events were observed. Conclusions/interpretation In non-insulin-treated type 2 diabetes, CGM plus standard care yielded less metabolic benefit than CGM combined with glucura. The combination of glucura and CGM also translated into improvements beyond glycaemic management. Trial registration German Clinical Trials Register DRKS00032537 Funding The study was funded by Perfood Laboratories GmbH","PeriodicalId":11164,"journal":{"name":"Diabetologia","volume":"175 1","pages":""},"PeriodicalIF":10.4000,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Diabetologia","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00125-026-06880-6","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}

引用次数: 0

Abstract

Abstract Aims/hypothesis CGM is increasingly recommended for non-insulin-treated type 2 diabetes according to the ADA Standards of Care 2026. However, its clinical benefit in high-quality standard care remains limited. This study evaluated whether addition of the digital therapeutic glucura, which delivers personalised lifestyle intervention and self-management guidance, improves glycaemic outcomes beyond CGM and standard care. Methods The study was a 6-month, multicentre, open-label RCT conducted at 24 sites in Germany (ID: DRKS00032537). Adults (≥18 years) with non-insulin-treated type 2 diabetes (HbA 1c 53–97 mmol/mol [7.0–11.0%], BMI≥25 kg/m 2 ) receiving standard care were randomly assigned (1:1) by centralised stratified block randomisation to glucura or a control app. Participants and study personnel were not masked to group assignment. Both groups used intermittent CGM every 3 months during the study. CGM sensors were not used prior to the study. The primary endpoint was the change in HbA 1c from baseline to 6 months. Secondary outcomes included weight change and patient-centric measures. Results Of 327 randomised participants (intervention: n =165; control: n =162), 320 were analysed (ITT population). The standalone CGM control group improved HbA 1c levels by 3.3 mmol/mol (0.30 percentage points); however, the intervention group showed greater reductions of 8.7 mmol/mol (0.80 percentage points) with an adjusted difference of –5 mmol/mol (−0.46 percentage points; 95% CI −7, −3 mmol/mol; p =0.00003). Within the intervention group, more participants achieved HbA 1c targets (<53 mmol/mol [<7.0%]: 55% vs 31%, OR 3.38, exploratory p =0.0002; <48 mmol/mol [<6.5%]: 27% vs 7%, OR 6.63, exploratory p =0.0001). The mean weight loss was also greater in the intervention group (4.11% vs 1.79%, p <0.0001). Significant improvements in mental health and diabetes-related distress were also observed. The positive effects were consistent across all subgroups. No device-related serious adverse events were observed. Conclusions/interpretation In non-insulin-treated type 2 diabetes, CGM plus standard care yielded less metabolic benefit than CGM combined with glucura. The combination of glucura and CGM also translated into improvements beyond glycaemic management. Trial registration German Clinical Trials Register DRKS00032537 Funding The study was funded by Perfood Laboratories GmbH

查看原文本刊更多论文

数字治疗胰高血糖联合CGM治疗2型糖尿病的疗效：超过6个月的随机对照试验

根据ADA护理标准2026，CGM越来越多地被推荐用于非胰岛素治疗的2型糖尿病。然而，它在高质量标准护理中的临床效益仍然有限。这项研究评估了数字治疗性血糖，提供个性化的生活方式干预和自我管理指导，是否改善了血糖治疗和标准治疗之外的血糖结局。方法：该研究是一项为期6个月、多中心、开放标签的随机对照试验，在德国24个地点进行（ID: DRKS00032537）。接受标准治疗的非胰岛素治疗2型糖尿病成人（≥18岁）（HbA 1c 53-97 mmol/mol [7.0-11.0%], BMI≥25 kg/ m2）通过集中分层块随机分配（1:1）随机分配到glucura或对照应用程序。参与者和研究人员不受组分配的影响。两组在研究期间每3个月进行一次间歇CGM。研究前未使用CGM传感器。主要终点是HbA 1c从基线到6个月的变化。次要结局包括体重变化和以患者为中心的测量。结果在327名随机受试者（干预组：n =165，对照组：n =162）中，分析了320名（ITT人群）。独立CGM对照组的HbA 1c水平提高了3.3 mmol/mol（0.30个百分点）；然而，干预组表现出更大的减少8.7 mmol/mol（0.80个百分点），调整后差异为-5 mmol/mol（- 0.46个百分点；95% CI - 7, - 3 mmol/mol; p =0.00003）。在干预组中，更多的参与者达到了HbA 1c目标（53 mmol/mol [<7.0%]: 55% vs 31%, OR 3.38，探索性p =0.0002; 48 mmol/mol [<6.5%]: 27% vs 7%, OR 6.63，探索性p =0.0001）。干预组的平均体重减轻也更大（4.11% vs 1.79%, p <0.0001）。还观察到心理健康和糖尿病相关痛苦方面的显著改善。在所有的亚组中，积极的影响是一致的。未观察到与器械相关的严重不良事件。结论/解释：在非胰岛素治疗的2型糖尿病中，CGM +标准治疗的代谢益处低于CGM +血糖升高。葡萄糖醛酸和CGM的结合也转化为血糖管理以外的改善。试验注册德国临床试验注册DRKS00032537资助本研究由Perfood Laboratories GmbH资助

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Diabetologia 医学-内分泌学与代谢

CiteScore

18.10

自引率

2.40%

发文量

193

审稿时长

1 months

期刊介绍： Diabetologia, the authoritative journal dedicated to diabetes research, holds high visibility through society membership, libraries, and social media. As the official journal of the European Association for the Study of Diabetes, it is ranked in the top quartile of the 2019 JCR Impact Factors in the Endocrinology & Metabolism category. The journal boasts dedicated and expert editorial teams committed to supporting authors throughout the peer review process.