Change in glycaemic control with structured diabetes self-management education in urban low-resource settings: multicentre randomised trial of effectiveness

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. Research design and methods. 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 Recruitment: 22nd until 29th 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.

Effectiveness of Diabetes Self-Management Education on Distress and HbA1C among Indian Type 2 Diabetes Mellitus Patients: A Randomized Controlled Trial

“…[ 21 ] A multicenter RCT conducted in an urban low-resource setting by Lamptey R et al . [ 29 ] studied the association between structured DSME and glycemic control. They found that structured DSME was not associated with a change in HbA1C at follow-up in low-resource settings.…”

The effectiveness of diabetes self-management education intervention on glycaemic control and cardiometabolic risk in adults with type 2 diabetes in low- and middle-income countries: A systematic review and meta-analysis

“…The characteristics of the included studies are reported in Table 1. Of the 44 studies, 21 were conducted in upper-middle-income countries , 21 in lower-middle-income countries [1,38,[72][73][74][75][76][77][78][79][80][81][82][83][84][85][86][87][88][89][90], and two were conducted in low-income countries [91,92], as grouped by the World Bank criteria [41]. The studies were conducted in diabetes clinics or hospitals (n = 15 [34%]), public or private hospitals/clinics (n = 21[48%]) and community settings/home-based locations (n = 8 [18%]).…”

“…Five trials used DM self-management-based coaching programmes [54,67,80,89,91], four trials used the empowerment approach and interactive teaching model [63,64,74,76], and three used the theory of self-efficacy as a theory or model to underpin intervention content [65,66,68]. Each of the following models was used by one trial only: the beliefs, attitudes, subjective norms and enabling factors (BASNEF) model [72]; the predisposing, reinforcing and enabling constructs in educational diagnosis and evaluation (PRECEDE) model [78]; the chronic care model [58]; clinic-based intensified diabetes management model (C-IDM) [60]; the healthbelief model [81]; the comprehensive systematic health education and promotion (SHEP) model [85]; the diabetes comprehensive care model (DCCM) [88]; the structured DSME model [38] and the lifestyle intervention holistic model (LIHM) [90]. The remaining 23 trials Approximately 73% (n = 32) of the interventions were delivered using a face-to-face format, 20% (n = 9) utilising face-to-face intervention with telephone follow-up and 7% (n = 3) using a remotely delivered text message/web-based intervention.…”

“…However, generalising evidence from HICs to LMICs needs to be interpreted with caution given cultural, ethnic, and economic disparities, as well as the variations among study populations [30,31]. Recent reviews conducted in LMICs demonstrated that DSME intervention, short-term nutrition education and/or lifestyle modification intervention may enhance glycaemic control [30,[32][33][34][35] and anthropometric measures [33]. However, to our knowledge, limited attempts have been made in the literature to assess the effectiveness of DSME interventions on a comprehensive outcome measures in LMICs [36][37][38][39], which include the effectiveness in the change in diabetes control and cardiometabolic risk, diabetes self-management behaviours and psychosocial well-being.…”

“…Recent reviews conducted in LMICs demonstrated that DSME intervention, short-term nutrition education and/or lifestyle modification intervention may enhance glycaemic control [30,[32][33][34][35] and anthropometric measures [33]. However, to our knowledge, limited attempts have been made in the literature to assess the effectiveness of DSME interventions on a comprehensive outcome measures in LMICs [36][37][38][39], which include the effectiveness in the change in diabetes control and cardiometabolic risk, diabetes self-management behaviours and psychosocial well-being. Thus, the aim of the present review is to comprehensively assess the effectiveness of DSME intervention on glycaemic control (eg.…”