Abstract
Background: Unlike in developed countries, the clinical effectiveness of diabetes self-management education (DSME) is not well-studied in the African context. Thus, this study sought to determine effects of DSME on clinical outcomes among type 2 diabetic (T2DM) patients in Ethiopia. Methods: Before-and-after controlled study design was employed, with random assignment of 116 T2DM adult patients to a nurse-led DSME group and 104 to a treatment-as-usual (comparison) group. A nurse-led DSME with six sessions supported with illustrative pictures handbooks and fliers was customized to local conditions and delivered by trained nurses over 9 months. Our primary outcome was a change in the proportion of people with target glycated hemoglobin (HbA1c ≤ 7%). We used chi-square test and mixed model analysis. Results: Seventy-eight (67%) and 64 (62%) participants assigned to intervention and comparison, respectively completed the study, and included in the final analysis. Mean HbA1c was significantly reduced by 2.88% within the intervention group and by 2.57% within the comparison group. However, change in the proportion of participants with target HbA1c and end-line mean HbA1c difference between the groups were not significant. Adjusted end-line fasting blood sugar (FBS), systolic blood pressure (SBP), and diastolic blood pressure (DBP) were significantly lower in the intervention group, by 27 ± 9 mg/dL, 12 ± 3, and 8 ± 2 mmHg, respectively. Conclusion: After 9 months of nurse-led DSME, HbA1c was significantly reduced within both groups but there was no significant difference in HbA1c between groups. The intervention also showed some clinically significant effects on blood pressure and FBS. Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT03185689, retrospectively registered on June 14, 2017 on ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03185689.