The effect of a primary care intervention on diabetes distress in individuals with newly diagnosed type 2 diabetes: a cluster-randomized controlled trial

Little is known about how best to intervene against diabetes distress in patients recently diagnosed with type 2 diabetes mellitus. We evaluate the effect of a structured, inter-sectoral primary care intervention on diabetes distress in individuals during the 12 months following diagnosis. In a cluster-randomized controlled trial, 30 general practice clinics in the Region of Southern Denmark were randomized 1:1 to an intervention or routine diabetes care. The intervention was designed to improve continuity of care, quality of care, and patient diabetes literacy. Patients completed the 17-item Diabetes Distress Scale (DDS-17) shortly after diagnosis and again 12 months later. The primary outcome was between-group changes in DDS scores over time. Secondary outcomes included between-group changes in HbA1c and HDL cholesterol levels between diagnosis and follow-up. A total of 193 patients completed the baseline questionnaire (58 control; 136 intervention), 87 also completed 12-month follow-up (23 control, 64 intervention). The initial DDS indicated that 28.4% of the entire sample experienced distress. This increased to 32.1% at follow-up. No significant group differences were found in changes of overall DDS scores (β = − 0.25, 95% CI = − 0.49, 0.00). A statistically significant effect was observed on interpersonal diabetes distress, with a group x time interaction (β = − 0.30, 95% CI = − 0.54, − 0.06). Reductions in the number of patients with abnormal baseline HbA1c were greater in the control group (OR = 4.25, 95% CI = 1.08, 16.80). Reductions in the number of patients with abnormal HDL were not significantly different between groups. This study provides novel insight into prevalence and severity of diabetes distress in the first year following diagnosis. While the intervention did not reduce overall diabetes distress, it appeared to stabilize diabetes-related interpersonal distress. We discuss these results in the context of the limited literature on diabetes distress in the first year following diagnosis, noting that low baseline distress, participant attrition, high quality of routine diabetes care, and design limitations may have muted intervention effects. ClinicalTrial.gov NCT05571306. Registered October 7, 2022.