Clinically diagnosed type 1 diabetes, non-autoimmune insulin-deficient diabetes (NAID), autoimmune type 1 diabetes, diabetes heterogeneity in children and young adults Nutritional, Metabolic, Endocrine
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of type 1 diabetes made before 25 years of age 2. Diabetes duration less than 12 months at enrolment 3. Receiving insulin treatment only 4. Registered within the Changing Diabetes in Children (CDiC) programme in Cameroon 5. Able and willing to provide informed consent or assent with parental/legal representative consent where applicable Healthy controls: Age- and sex-matched individuals without diabetes and unrelated to diabetes participants
Exclusion criteria
Exclusion criteria: 1. Critically ill patients requiring urgent hospital admission or emergency intervention 2. Pregnant participants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical and metabolic characteristics distinguishing NAID from autoimmune type 1 diabetes measured using islet autoantibody status (GADA, IA-2A, ZnT8A), random or stimulated C-peptide concentrations, clinical and anthropometric phenotyping, and pancreatic imaging measurements at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Beta-cell function measured using C-peptide concentrations measured using direct electrochemiluminescence immunoassay on the 601 module of the Roche Cobas 8000 automated instrument (Roche Diagnostics, Manheim, Germany) at baseline, 6 months, 1 year, 2 years, and 3 years;Glycaemic control measured using HbA1c at baseline, 1 year, 2 years, and 3 years;Severe hypoglycaemia and diabetic ketoacidosis (DKA) episodes measured using self report at 6 months, 1 year, 2 years, and 3 years;Pancreatic shape, volume and architecture measured using a standardised MRI protocol at 6 months;Beta-cell function during a mixed meal tolerance test measured using direct electrochemiluminescence immunoassay on the 601 module of the Roche Cobas 8000 automated instrument (Roche Diagnostics, Manheim, Germany) at 6 months | — |
Countries
Cameroon