Prospective Study of Non-Autoimmune Insulin-Deficient Diabetes Subtype in Young Individuals in sub-Saharan Africa (PANDA study): study protocol
Jean Claude Katte, Emmanuel Gwan, Mesmin Dehayem, Moffat Nyirenda, Andrew Hattersley, Angus Jones, Eugene SobngwiIntroduction
Diabetes affects over 24 million people in Africa, with type 1 and type 2 diabetes being the most recognised forms. Recent studies in sub-Saharan Africa have identified a substantial proportion of children and young adults with clinically diagnosed type 1 diabetes (T1D) who lack evidence of islet autoimmunity despite severe insulin deficiency, suggesting a distinct non-autoimmune insulin-deficient diabetes subtype (NAID). This study aims to characterise the clinical phenotype, assess the underlying pathophysiology and longitudinal progression of this diabetes subtype.
Methods and analysis
This is a prospective observational study comprising a cross-sectional comparative analysis and a 3-year longitudinal follow-up cohort. The study will recruit 355 children and young adults aged below 25 years with recently (diabetes duration ≤12 months) diagnosed T1D, with an anticipated estimate of 240 NAID and 115 autoimmune T1D cases. In addition, a minimum of 240 age-matched and sex-matched individuals without diabetes will be recruited as healthy controls. Participants will undergo detailed clinical phenotyping, laboratory assessment including islet autoantibody and C-peptide testing and biospecimen collection for biomarker analyses. A nested mechanistic substudy will include a mixed meal tolerance test and pancreatic MRI to assess pancreatic function and structure. Participants with diabetes will be followed for 3 years to assess longitudinal changes in endogenous insulin secretion, glycaemic response and acute metabolic complications. The study will provide the first prospective characterisation of NAID in sub-Saharan Africa and is expected to improve understanding of its clinical phenotype, natural history and underlying biology, thereby informing future diagnostic and therapeutic strategies.
Ethics and dissemination
This study protocol was approved by the National Ethics Committee for Human Health Research (IRB No 2026/05/1930/CE/CNERSH/SP/SPA). All participants will provide written informed consent or assent with parental consent, where appropriate, before enrolment into the study. Research findings will be disseminated through peer-reviewed publications, policy briefs, stakeholder meetings and presentations at national and international scientific conferences.
Trial registration number