Diabetes, obesity & metabolism · 2026
Effects of coaching with data management system intervention or usual care on glycemic control in patients with type 2 diabetes: A multicentre, randomised controlled trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Verket Marlo, Buitkamp Larissa F, Kanna Niveditha Daneeza Dinesh, Thomas Andreas, Denger Ralf, Petry Friedrich, Schubert-Olesen Oliver, Stütz Wolfgang, Simon Jörg, Pihusch Monika, Dötsch Iris, Krob Gabriela, Tews Dietrich, Stolz David, Bergis Dominik, Lenthe Thorsten, Schmidt-Mergenthaler Frank, Dahlmann Elke, Boehm Kathrin, Jacobsen Malte, Müller-Wieland Dirk, Brandts Julia
Аннотация
AIMS: Integrating a diabetes management system (DMS) and personal coaching in patient care may reduce the burden of type 2 diabetes (T2DM) on patients and help address the multifaceted challenges associated with diabetes management. This study aims to assess the impact of the DMS with online coaching in patients with T2DM on changes in HbA1c levels, quality of life, and usability over 26 weeks.
MATERIALS AND METHODS: In a multicentre, randomised, controlled trial, adults with T2DM were randomised 1:1 to either 52 weeks of DMS with remote coaching or to usual care by their diabetologist. The DMS enabled a digital diary of blood pressure, blood glucose, and other health parameters, while coaching sessions included structured assessments of individual patient needs. The primary endpoint was changes in the HbA1c level from baseline to 26 weeks. Secondary endpoints included health-related quality of life (SF-12), diabetes-related problems (PAID), and DMS usability (System Usability Scale) at 26-week follow-up.
RESULTS: One hundred and fourteen participants (49 females, 58 ± 11 years old [mean ± standard deviation], HbA1c: 8.3% ± 0.7%, body mass index [BMI]: 35.3 ± 7.9 kg/m2, diabetes duration: 13.6 ± 7.7 years) were randomised and completed baseline. Ninety participants (39 female, age: 58 ± 11 years old, HbA1c: 8.3% ± 0.7%, BMI: 35.2 ± 7.6 kg/m2, diabetes duration: 14 ± 8 years) completed 26-week follow-up. The HbA1c levels improved significantly in the intervention group in comparison to the control group (-0.9% ± 1.0% vs. -0.5% ± 1.0%, p = 0.044). No significant differences were observed in SF-12 and PAID scores at 26-week follow-up. Thirty-two of forty-three participants who used DMS completed the SUS questionnaire with an average score of 55.4 ± 27.9.
CONCLUSIONS: DMS with coaching improved glycaemic control compared to usual care in patients with T2DM at 26-week follow-up.
MATERIALS AND METHODS: In a multicentre, randomised, controlled trial, adults with T2DM were randomised 1:1 to either 52 weeks of DMS with remote coaching or to usual care by their diabetologist. The DMS enabled a digital diary of blood pressure, blood glucose, and other health parameters, while coaching sessions included structured assessments of individual patient needs. The primary endpoint was changes in the HbA1c level from baseline to 26 weeks. Secondary endpoints included health-related quality of life (SF-12), diabetes-related problems (PAID), and DMS usability (System Usability Scale) at 26-week follow-up.
RESULTS: One hundred and fourteen participants (49 females, 58 ± 11 years old [mean ± standard deviation], HbA1c: 8.3% ± 0.7%, body mass index [BMI]: 35.3 ± 7.9 kg/m2, diabetes duration: 13.6 ± 7.7 years) were randomised and completed baseline. Ninety participants (39 female, age: 58 ± 11 years old, HbA1c: 8.3% ± 0.7%, BMI: 35.2 ± 7.6 kg/m2, diabetes duration: 14 ± 8 years) completed 26-week follow-up. The HbA1c levels improved significantly in the intervention group in comparison to the control group (-0.9% ± 1.0% vs. -0.5% ± 1.0%, p = 0.044). No significant differences were observed in SF-12 and PAID scores at 26-week follow-up. Thirty-two of forty-three participants who used DMS completed the SUS questionnaire with an average score of 55.4 ± 27.9.
CONCLUSIONS: DMS with coaching improved glycaemic control compared to usual care in patients with T2DM at 26-week follow-up.