Change in glycaemic control with structured diabetes self-management education in urban low-resource settings: multicentre randomised trial of effectiveness
Roberta Lamptey, Mary Amoakoh‐Coleman, Mary Moffett Barker, Samuel Iddi, Michelle Hadjiconstantinou, Melanie J. Davies, Daniel Darko, Irène Akua Agyepong, Franklyn Acheampong, Mary Commey, Alfred Edwin Yawson, Diederick E. Grobbee, George Adjei, Kerstin Klipstein‐Grobusch
Abstract
BACKGROUND: In high-resource settings, structured diabetes self-management education is associated with improved outcomes but the evidence from low-resource settings is limited and inconclusive. AIM: To compare, structured diabetes self-management education to usual care, in adults with type 2 diabetes, in low-resource settings. DESIGN: Single-blind randomised parallel comparator controlled multi-centre trial. Adults (> 18 years) with type 2 diabetes from two hospitals in urban Ghana were randomised 1:1 to usual care only, or usual care plus a structured diabetes self-management education program. Randomisation codes were computer-generated, and allotment concealed in opaque numbered envelopes. The intervention effect was assessed with linear mixed models. MAIN OUTCOME: Change in HbA1c after 3-month follow-up. Primary analysis involved all participants. CLINICALTRIAL: gov identifier:NCT04780425, retrospectively registered on 03/03/2021. RESULTS: January 2021. We randomised 206 participants (69% female, median age 58 years [IQR: 49-64], baseline HbA1c median 64 mmol/mol [IQR: 45-88 mmol/mol],7.9%[IQR: 6.4-10.2]). Primary outcome data was available for 79 and 80 participants in the intervention and control groups, respectively. Reasons for loss to follow-up were death (n = 1), stroke(n = 1) and unreachable or unavailable (n = 47). A reduction in HbA1c was found in both groups; -9 mmol/mol [95% CI: -13 to -5 mmol/mol], -0·9% [95% CI: -1·2% to -0·51%] in the intervention group and -3 mmol/mol [95% CI -6 to 1 mmol/mol], -0·3% [95% CI: -0·6% to 0.0%] in the control group. The intervention effect was 1 mmol/mol [95%CI:-5 TO 8 p = 0.726]; 0.1% [95% CI: -0.5, 0.7], p = 0·724], adjusted for site, age, and duration of diabetes. No significant harms were observed. CONCLUSION: In low-resource settings, diabetes self-management education might not be associated with glycaemic control. Clinician's expectations from diabetes self-management education must therefore be guarded.