Morbidity and Complications of Diabetes Mellitus in Children andAdolescents in Ghana:Protocol for a Longitudinal Study
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Date
2021
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JMIR Research Protocols
Abstract
Background: Diabetes is associated with premature morbidity and mortality from its many complications. There are limiteddata on the chronic complications of diabetes in children and adolescents in sub-Saharan Africa.Objective: The study aims to determine the (1) burden and related factors of chronic systemic complications of diabetes,including diabetic and nondiabetic ocular conditions in children and adolescents, and (2) quality of life (QoL) of participantscompared to healthy controls. This manuscript describes the study methodology.Methods: Demographic information, medical history, anthropometric measurements, and laboratory characteristics werecollected, and the participants were screened for microvascular and macrovascular complications as well as nondiabetic oculardisease. QoL questionnaires were administered to participants, their caregivers, and controls. Participants were followed upannually up to 3 years to determine the natural history of and trends in these conditions. SPSS Version 25.0 will be used for dataanalysis. Continuous and categorical data will be presented as mean (SD) and as percentages (%), respectively. t tests and analysisof variance will be used to compare means, and chi-square tests will be used to compare categorical data. Correlation, regression,and logistic regression analyses will be employed to establish linear associations and causal associations as appropriate. Relative risk and odds ratios will be used to estimate risk. QoL outcomes in Ghanaian children and adolescents with diabetes mellituscompared with caregivers and healthy controls will be assessed using the Pediatric Quality of Life inventory. Significance willbe set at α=.05.Results: Institutional approval from the Ethical and Protocol Review Committee of the University of Ghana Medical Schoolwas received on August 22, 2014 (Protocol Identification Number: MS-Et/M.12-P4.5/2013-2014). Funding for the project wasreceived from the University of Ghana Research Fund (#UGRF/9/LMG-013/2015-2016) in March 2016. Patient recruitment,clinical examination, and data collection commenced in August 2016 and was completed in September 2019. A total of 58 childrenand adolescents with diabetes mellitus have been recruited. Blood samples were stored at –80 °C for analysis, which was completedat the end of July 2020. Data analysis is ongoing and will be completed by the end of December 2020. Investigators plan to submitthe results for publication by the end of February 2021.Conclusions: The prevalence, natural history, trends in diabetic complications and nondiabetic ocular disease, and QoL willbe provided. Our data may inform policies and interventions to improve care given to children and adolescents with diabetes.
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Keywords
Diabetes Mellitus, Type 1 Diabetes, Type 2 Diabetes, Microvascular