JMIR Publications

ABSTRACT

Background:

Diabetes is associated with premature morbidity and mortality from its many complications. There is limited data on the chronic complications of diabetes in children and adolescents in sub-Saharan Africa.

Objective:

The study aims to: i) determine the burden and related factors of chronic systemic complications of diabetes, diabetic and non-diabetes ocular conditions in children and adolescents, and ii) the quality of life (QoL) of the participants compared to healthy controls. This manuscript describes the study methodology.

Methods:

Demographic, medical history, anthropometric measurements and laboratory characteristics were collected, and the participants screened for microvascular and macrovascular complications as well as non-diabetic ocular disease. QoL questionnaires were administered to participants, their care givers, and controls. Participants were followed up annually to up to 3 years to determine the natural history and trends in these conditions. The statistical package for social sciences (SPSS Version 25.0) will be used for data analysis. Continuous and categorical data will be presented as mean and standard deviation (SD) and as percentages (%), respectively. T-test and ANOVA will be used to compare means and Chi-square for categorical data. Correlation, regression, and logistic regression will be employed to establish linear associations and causal associations as appropriate. Relative risk and Odds ratios will be used to estimate risk. Quality of life (QoL) outcomes in Ghanaian children and adolescents with diabetes mellitus compared with caregivers and healthy controls will be assessed using the PedsQL™ inventory. Significance will be set at α = 0.05.

Results:

Institutional approval from the Ethical and Protocol Review Committee (EPRC) of the University of Ghana Medical School was received on the 22nd Aug 2014 (Protocol Identification Number: MS-Et/M.12-P4.5/2013-2014). Funding for the project was received 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 children and adolescents with diabetes mellitus have been recruited. Blood samples are stored at -80 degrees Celsius for analysis which is ongoing and should be completed by end of July 2020. Data analysis is ongoing and will be completed by the end of October 2020. Investigators plan to submit the results for publication by the end of December 2020.

Conclusions:

The prevalence, natural history, trends in diabetic complications and non-diabetic ocular disease, and quality of life will be provided. Our data may inform policies and interventions to improve care given to children and adolescents with diabetes.