Understanding the Characteristics of Young-onset Diabetes in Sub-Saharan Africa

The specific objectives will be to; (1) characterise a population with clinically diagnosed type 1 diabetes and to determine the proportion of islet autoantibody positivity rates and to compare with a similar cohort of patients in the UK, (2) to determine the proportion of participants with retained endogenous insulin secretion (C-peptide > 600pmol/l) and whether they have evidence of autoimmunity as assessed by islet autoantibody and the type 1 diabetes genetic risk score

Study setting: This study will be a multi-center cross-sectional study of clinically diagnosed type 1 diabetes patients who are currently on insulin treatment who are being followed-up in existing diabetes care centers in 4 sub-Saharan African countries; Cameroon, Uganda, Tanzania and South Africa. Recruitment will take place at regional diabetes care centers which usually serve as the main diabetes treatment hub for many smaller spoke clinics in the sub-region. In Cameroon, the Yaounde Central Hospital and the Bafoussam Regional Hospital will serve as main clinical sites. In Uganda the clinical sites involved are the Mulago National Referral and Teaching Hospital, St. Francis Hospital Nsambya, all in Kampala and the Masaka Regional Referral Hospital. The Muhimbili National Hospital in Dar Es Salaam will serve as the main clinical site in Tanzania. Cameroon, Uganda and Tanzania will carry out primary data collection over the study period while South Africa (University of Witwatersrand Medical School) will provide secondary data consisting of a minimal dataset and relevant collected samples for analysis. All these centers have existing diabetes care clinics with experienced staff who are used to collecting and providing data for research purposes.

Eligibility: All patients with a clinical diagnosis of type 1 diabetes or young-onset insulin treated diabetes, who were diagnosed before the age of 30 years will be eligible to be enrolled into the study. We estimated a minimum total sample size of 500 participants will have a high precision with 95% confidence intervals of 17-25% around a prevalence of 20% for a clinical or biological characteristics (e.g. retained C-peptide or presence of islet auto-antibodies) and 46-54% around a prevalence of 50%.

Sampling method: We will follow a systematic sampling method, enrolling consecutive eligible participants from the different primary collection clinical sites.

Enrollment: All consented patients will be interviewed using a structured pre-tested questionnaire (Data Collection Form) by a trained study staff to collect relevant information; demographic, socioeconomic, lifestyle, family history, history of diabetes and diabetes complications. The questionnaire used in this study is available in English and has been translated into the major local language(s); the appropriate questionnaire is used according to the participant's preference. After the interview, a short clinical examination will be performed to record anthropometric characteristics (weight, height, waist and hip circumferences) and blood pressure.