Effects of data management system with online coaching intervention or usual care on glycemic control in patients with type 2 diabetes: a multicenter, randomized controlled trial

Background: Integrating a digital health 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 optimizing outcomes and adherence by monitoring changes in HbA1c levels and vital parameters over 26 weeks.

Methods: Patients with T2DM, an HbA1c>7.5%, and no coaching session in the past year were enrolled in this multicenter, randomized, controlled trial. They were randomly assigned in a 1:1 ratio to either use a DMS with online coaching or receive usual care by their diabetologist for 26 weeks. DMS could connect to various devices, such as blood pressure monitors, blood glucose meters, pedometers, etc. DMS stores the data and displays it over time, enabling the patient and the treating clinician to see the changes over time in individual parameters, such as glucose, blood pressure, weight, and number of steps. Online coaching, by a diabetes care educator, addressed the patient’s needs by discussing daily issues, identifying behaviors and barriers that may positively or negatively impact them, and determining whether additional support is needed. The online coaching sessions occurred weekly in the first month, every two weeks for months 2 and 3, and then monthly. At baseline and 26 weeks, HbA1c was measured and patients filled out a diabetes treatment satisfaction questionnaire (DTSQ).

Results: A total of 92 participants (40 female, age: 58±11 years old [mean±standard deviation], HbA1c: 8.3%±0.7%, body mass index [BMI]: 35.2±7.5 kg/m², diabetes duration: 13±5 years) were included. Participants in the intervention group (n=45, 17 female, mean age 59±10 years) had a mean BMI of 36.4±8.7 kg/m², a diabetes duration of 12±4 years, and an HbA1c of 8.3%±0.6%, with a DTSQ score of 33.6±6.9. In comparison, the control group (n=47, 23 female, mean age 58±12 years) had a moderately lower BMI (34.1±6.2 kg/m²) and a slightly longer diabetes duration (14±6 years) but a similar HbA1c (8.3%±0.7%) and slightly higher DTSQ score (35.2±5.4). However, these differences were not significant. A reduction in HbA1c levels was observed in the intervention group compared to the control group after 26 weeks. 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). Moreover, the score of DTSQ after 26 weeks improved significantly in the intervention group than in the control group (1.6±5.9 vs. -1.6±5.0, p=0.008). The average number of coaching sessions was 10±5. The top three topics of the coaching session were weight reduction, diabetes management and nutrition assessment.

Conclusions: DMS with coaching may improve glycaemic control and treatment satisfaction compared to usual care in patients with T2DM.

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Artikel online veröffentlicht:
28. Mai 2025