TY - JOUR
T1 - Change in glycaemic control with structured diabetes self-management education in urban low-resource settings
T2 - multicentre randomised trial of effectiveness
AU - Lamptey, Roberta
AU - Amoakoh-Coleman, Mary
AU - Barker, Mary Moffett
AU - Iddi, Samuel
AU - Hadjiconstantinou, Michelle
AU - Davies, Melanie
AU - Darko, Daniel
AU - Agyepong, Irene
AU - Acheampong, Franklyn
AU - Commey, Mary
AU - Yawson, Alfred
AU - Grobbee, Diederick E
AU - Adjei, George Obeng
AU - Klipstein-Grobusch, Kerstin
N1 - Funding Information:
We acknowledge the support of MDS-Lancet laboratories Ghana, Leicester Diabetes Centre, National Institute for Health Research Applied Research Collaboration-East Midlands, Leicester General Hospital, Leicester, U.K and National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, UK for providing the intervention materials, Sedzro Kojo Mensah, for managing the generation of the randomisation codes.
Funding Information:
RL is supported by the UMC Utrecht Global Health Support PhD programme. This study was supported in part by Novo Nordisk. They had no role in the study design, collection, analysis, interpretation of data, writing of the report or decision to submit the article for publication.
Publisher Copyright:
© 2023, The Author(s).
PY - 2023/2/24
Y1 - 2023/2/24
N2 - 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: 22
nd until 29
th 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.
AB - 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: 22
nd until 29
th 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.
KW - DSME
KW - Diabetes
KW - HbA1c
KW - Low-resource
KW - Self-care
UR - http://www.scopus.com/inward/record.url?scp=85148965953&partnerID=8YFLogxK
U2 - 10.1186/s12913-023-09188-y
DO - 10.1186/s12913-023-09188-y
M3 - Article
C2 - 36829179
SN - 1472-6963
VL - 23
JO - BMC Health Services Research
JF - BMC Health Services Research
IS - 1
M1 - 199
ER -