Patient-centered communication and shared decision making to reduce HbA1c levels of patients with poorly controlled type 2 diabetes mellitus - results of the cluster-randomized controlled DEBATE trial

BACKGROUND: Does an intervention designed to foster patient-centered communication and shared decision making among GPs and their patients with poorly controlled type 2 diabetes mellitus reduce the level of HbA1c.

METHODS: The DEBATE trial is a cluster-randomized controlled trial conducted in German primary care and including patients with type 2 diabetes mellitus having an HbA1c level of 8.0% (64 mmol/mol) or above at the time of recruitment. Data was measured before intervention (baseline, T0), 6-8 months (T1), 12-14 months (T2), 18-20 months (T3), and 24-26 months (T4) after baseline. Main outcome measure is the level of HbA1c.

RESULTS: In both, the intervention and the control group the decline of the HbA1c level from T0 to T4 was statistically significant (- 0.67% (95% CI: - 0.80,-0.54%; p < 0.0001) and - 0.64% (95% CI: - 0.78, - 0.51%; p < 0.0001), respectively). However, there was no statistically significant difference between both groups.

CONCLUSIONS: Although the DEBATE trial was not able to confirm effectiveness of the intervention tested compared to care as usual, the results suggest that patients with poorly controlled type 2 diabetes are able to improve their blood glucose levels. This finding may encourage physicians to stay on task to regularly approach this cohort of patients.

TRIAL REGISTRATION: The trial was registered at ISRCTN registry under the reference ISRCTN70713571 .