{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T14:57:35Z","timestamp":1790866655051,"version":"4.1.0"},"reference-count":43,"publisher":"Springer Science and Business Media LLC","license":[{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Perfood Laboratories"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Diabetologia"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims\/hypothesis<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      The study was a 6-month, multicentre, open-label RCT conducted at 24 sites in Germany (ID: DRKS00032537). Adults (\u226518 years) with non-insulin-treated type 2 diabetes (HbA\n                      <jats:sub>1c<\/jats:sub>\n                      53\u201397 mmol\/mol [7.0\u201311.0%], BMI\u226525 kg\/m\n                      <jats:sup>2<\/jats:sup>\n                      ) 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\n                      <jats:sub>1c<\/jats:sub>\n                      from baseline to 6 months. Secondary outcomes included weight change and patient-centric measures.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Of 327 randomised participants (intervention:\n                      <jats:italic>n<\/jats:italic>\n                      =165; control:\n                      <jats:italic>n<\/jats:italic>\n                      =162), 320 were analysed (ITT population). The standalone CGM control group improved HbA\n                      <jats:sub>1c<\/jats:sub>\n                      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 \u20135 mmol\/mol (\u22120.46 percentage points; 95% CI \u22127, \u22123 mmol\/mol;\n                      <jats:italic>p<\/jats:italic>\n                      =0.00003). Within the intervention group, more participants achieved HbA\n                      <jats:sub>1c<\/jats:sub>\n                      targets (&lt;53 mmol\/mol [&lt;7.0%]: 55% vs 31%, OR 3.38, exploratory\n                      <jats:italic>p<\/jats:italic>\n                      =0.0002; &lt;48 mmol\/mol [&lt;6.5%]: 27% vs 7%, OR 6.63, exploratory\n                      <jats:italic>p<\/jats:italic>\n                      =0.0001). The mean weight loss was also greater in the intervention group (4.11% vs 1.79%,\n                      <jats:italic>p<\/jats:italic>\n                      &lt;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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions\/interpretation<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                    <jats:p>\n                      <jats:bold>Trial registration<\/jats:bold>\n                      German Clinical Trials Register DRKS00032537\n                    <\/jats:p>\n                    <jats:p>\n                      <jats:bold>Funding<\/jats:bold>\n                      The study was funded by Perfood Laboratories GmbH\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00125-026-06880-6","type":"journal-article","created":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T14:24:12Z","timestamp":1790864652000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy of the digital therapeutic glucura combined with CGM in the treatment of type 2 diabetes: a randomised controlled trial over 6 months"],"prefix":"10.1007","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0406-9529","authenticated-orcid":false,"given":"Guido","family":"Freckmann","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0504-6465","authenticated-orcid":false,"given":"Inke R.","family":"K\u00f6nig","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3179-7895","authenticated-orcid":false,"given":"Hanna","family":"Grube","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maren","family":"Vens","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-8665-9137","authenticated-orcid":false,"given":"Oliver","family":"Witt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vanessa","family":"Kappelmeier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kim L.","family":"Pethahn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Sina","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Othmar","family":"Moser","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-4897-1481","authenticated-orcid":false,"given":"Torsten","family":"Schr\u00f6der","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,10,1]]},"reference":[{"issue":"9467","key":"6880_CR1","doi-asserted-by":"publisher","first-page":"1333","DOI":"10.1016\/S0140-6736(05)61032-X","volume":"365","author":"M Stumvoll","year":"2005","unstructured":"Stumvoll M, Goldstein BJ, van Haeften TW (2005) Type 2 diabetes: principles of pathogenesis and therapy. 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The authors would like to thank the clinicians, study investigators and study site personnel (see\n                      \n                      for list of participating investigators). Additionally, we would like to acknowledge the study centres and the Centre for Clinical Trials L\u00fcbeck (ZKS), including the study monitors, for their valuable contributions to the success of this study. Special thanks are extended to D. Burziwoda-von Papen from Perfood Laboratories for his unwavering support, and to A. Droste, N. Cascante, K. Schultes, F. Schliess and J. Ajendra from Perfood Laboratories for their excellent scientific support, project and trial management, and support of clinical data management.","order":1,"name":"Ethics","label":"Acknowledgements","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"The anonymised dataset underlying the findings of this study may be available upon reasonable written request to the sponsor (Perfood GmbH, L\u00fcbeck, Germany). Requests must include a description of the proposed scientific analysis and will be subject to a data use agreement consistent with applicable GDPR requirements. Data sharing is restricted to non-commercial academic research conducted within the European Union, and requires approval by the study's ethics committee. Data will be available for a maximum of 5 years following study completion. The trial protocol and statistical analysis plan can be downloaded from\n                      \n                      ..","order":2,"name":"Ethics","label":"Data availability","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"This work was funded by Perfood Laboratories GmbH, the manufacturer of the prescription digital therapeutic glucura. The funder was involved in study design and data collection but did not impose any restrictions regarding publication.","order":3,"name":"Ethics","label":"Funding","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"VK, KLP, OW and TS are employed at Perfood Laboratories GmbH. TS and OW are co-founders of Perfood Laboratories GmbH and minority shareholders. GF is general manager and medical director of the Institute for Diabetes Technology (IfDT, Institut f\u00fcr Diabetes-Technologie Ulm GmbH, Germany), which carries out clinical studies, e.g. of medical devices for diabetes therapy, on its own initiative and on behalf of various companies. GF and the Institut f\u00fcr Diabetes-Technologie Ulm have received speakers\u2019 honoraria, research support and\/or consulting fees in the last 3 years from the following companies: Abbott, Ascensia, Bionime, Boydsense, Dexcom, Glucoset, Insulet, I-Sens, Lilly Deutschland, Menarini, Perfood, Pharmasens, Roche, Sinocare, Vertex and Ypsomed. OM declares clinical trial support from the S\u00ear Cymru\u00a0II COFUND Fellowship\/European Union, Novo Nordisk A\/S, Novo Nordisk AT, Abbott Diabetes Care, Sanofi, Dexcom, Team Novo Nordisk, SAIL, Maisels Brauerei, Medtronic AT, the European Foundation for the Study of Diabetes (EFSD)\/European Association for the Study of Diabetes (EASD), Falke, BISp, Perfood, Ypsomed, Sinocare, Roche and OneTwenty; presenter honoraria from Medtronic AT, Medtronic International, Eli Lilly, Novo Nordisk, Sanofi, TAD Pharma, the ADA, Diatec, Berufsverband deutscher Internist*innen, Dexcom, Astra Zeneca, Ypsomed, Insulet, Diabetologen Hessen and Abbott; conference travel support from Novo Nordisk A\/S, Novo Nordisk AT, Novo Nordisk UK, Medtronic AT, Sanofi, the EASD, Austrian Diabetes Association (OEDG) and German Diabetes Society (DDG); and advisory board for Sanofi, TAD Pharma, Dexcom, Perfood, Medtronic, Hedia, Roche, Tandem and mylife Diabetes Care. The remaining authors declare that there are no relationships or activities that might bias, or be perceived to bias, their work.","order":4,"name":"Ethics","label":"Authors\u2019 relationships and activities","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"IRK and TS conceived and designed the study. GF and OM were responsible for clinical oversight and contributed to data acquisition and interpretation. VK, KLP, CS and OW contributed to study coordination, data management and data interpretation. IRK, HG and MV performed the statistical analyses and interpreted the data. OM and TS drafted the first version of the manuscript. All authors contributed to data interpretation, critically reviewed and edited the manuscript for important intellectual content, and approved the final version of the manuscript. TS is the guarantor of this work.","order":5,"name":"Ethics","label":"Contribution statement","group":{"name":"EthicsHeading","label":"Ethics"}}]}}