A study investigating a new form of insulin-deficient diabetes in children and young adults in Cameroon

ISRCTN	ISRCTN15312527
DOI	https://doi.org/10.1186/ISRCTN15312527
Internal reference number assigned by funder	Wellcome Trust Early Career Fellowship Award: 326531/Z/25/Z
Sponsors	University of Exeter, Recherche Santé et Développement (RSD) Institute, Cameroon, Central Hospital of Yaoundé
Funders	Wellcome Trust, University of Exeter, Changing Diabetes in Children Programme Cameroon (in-kind support)

Submission date: 09/07/2026
Registration date: 16/07/2026
Last edited: 10/07/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Many children and young adults in sub-Saharan Africa who are diagnosed with type 1 diabetes appear to have a different form of diabetes that causes severe insulin deficiency but lacks the autoimmune features usually seen in type 1 diabetes. This study aims to understand this newly recognised condition and determine how it differs from classical type 1 diabetes.

Who can participate?
Children and young adults aged below 25 years diagnosed with type 1 diabetes within the previous year and healthy volunteers of similar age and sex.

What does the study involve?
Participants will complete questionnaires, physical examinations and blood tests. Individuals with diabetes will be followed for three years. Some participants will also undergo specialised pancreatic function testing and MRI scans.

What are the possible benefits and risks?
Participants may benefit from detailed diabetes assessment and closer follow-up. Risks include minor discomfort associated with blood sampling and inconvenience related to study visits and imaging procedures.

Where is the study run from?
Changing Diabetes in Children Clinic, Yaoundé Central Hospital (Cameroon)

When is the study starting and how long is it expected to run for?
September 2026 to December 2030

Who is funding the study?
1. Wellcome Trust Early Career Fellowship Award through the University of Exeter Medical School (UK)
2. Changing Diabetes in Children Programme Cameroon (in-kind support)

Who is the main contact?
Dr Jean Claude Njabou Katte, j.njabou-katte@exeter.ac.uk

Contact information

Dr Jean Claude Njabou Katte
Principal investigator, Scientific

University of Exeter Medical School
RILD Building, RD&E Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom

Phone	+44 (0)7918153184
Email	j.njabou-katte@exeter.ac.uk

Dr Emmanuel Gwan
Public

Maison Rose Damas
Yaoundé
0000
Cameroon

Phone	+237 (0)673411724
Email	emmagwan73@gmail.com

Study information

Primary study design	Observational
Observational study design	Cohort study
Scientific title	Prospective study of non-Autoimmune insuliN-Deficient diabetes subtype in young individuals in sub-saharan Africa
Study acronym	PANDA
Study objectives	1. To characterise the clinical features and underlying pathophysiological mechanisms associated with the non-autoimmune insulin-deficient diabetes subtype (NAID) at diagnosis and to understand the early clinical course of the condition in children and young adults in Cameroon. 2. To determine the risk factors and clinical and metabolic characteristics that are associated with the non-autoimmune insulin-deficient diabetes subtype at diagnosis. 3. To assess for differences in the progression of beta-cell loss, glycaemic changes and rates of metabolic complications between non-autoimmune insulin-deficient diabetes and autoimmune type 1 diabetes over 3 years from diabetes diagnosis. 4. To determine the pancreatic architectural and functional (exocrine/endocrine) disorders associated with the non-autoimmune insulin-deficient diabetes subtype.
Ethics approval(s)	Approved 21/05/2026, Cameroon National Ethics Committee for Research on Human Health (Ministry of Public Health, Yaoundé, P.O Box 1937, Cameroon; +237 (0)690 99 67 81; setcominae@gmail.com), ref: 2026/05/1930/CE/CNERSH/SP/SPA
Health condition(s) or problem(s) studied	Clinically diagnosed type 1 diabetes, non-autoimmune insulin-deficient diabetes (NAID), autoimmune type 1 diabetes, diabetes heterogeneity in children and young adults
Methodology	Eligible participants will be identified from the national Changing Diabetes in Children (CDiC) registry and through consecutive recruitment of newly diagnosed cases attending the Yaoundé Central Hospital CDiC clinic. At baseline, participants will undergo the following: 1. Informed consent procedures 2. Structured interviews collecting demographic, clinical, environmental and socioeconomic information 3. Physical examination and anthropometric measurements 4. Collection of blood, urine, stool and saliva samples for laboratory analyses 5. Assessment of diabetes complications Participants with diabetes will subsequently be followed according to routine clinical review schedules approximately every 3 months for 3 years, with annual study assessments including glycaemic measurements, insulin requirements and beta-cell function evaluation. A subset of participants will undergo the following: 1. Mixed Meal Tolerance Testing (MMTT) to assess endogenous insulin secretion 2. Magnetic Resonance Imaging (MRI) to evaluate pancreatic morphology and exocrine pancreatic function No study interventions will be administered, and participants will continue receiving standard clinical care throughout the study.
Intervention type	Other
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2030

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	1 Year
Upper age limit	25 Years
Sex	All
Target sample size at registration	595
Key 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
Key exclusion criteria	1. Critically ill patients requiring urgent hospital admission or emergency intervention 2. Pregnant participants
Date of first enrolment	01/09/2026
Date of final enrolment	31/10/2029

Locations

Countries of recruitment

Cameroon

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

10/07/2026: Study's existence confirmed by the University of Exeter.