Capillary markers to predict type 1 diabetes

Determining minimally invasive alternatives to glucose, proinsulin and C-peptide in early-stage type 1 diabetes

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18189469

Enrollment

Registered

2025-12-10

Start date

2025-12-01

Completion date

Unknown

Last updated

2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes Nutritional, Metabolic, Endocrine

Interventions

49 children with two or more diabetes autoantibodies and aged <18 years of age, will be invited to take part. They will be identified from research established research monitoring programmes where the

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1. Willing and able to give informed consent for participation, or assent with parental consent 2. Aged =2 islet antibodies)

Exclusion criteria

Exclusion criteria: 1. On insulin treatment for diabetes 2. On any medication that may interfere with glucose metabolism (including but not limited to steroids)

Design outcomes

Secondary

Measure	Time frame
Secondary (Part A): 1. Sensitivity and specificity of capillary glucose at 5.6 mmol/L, 7.0 mmol/L (fasting), and 7.8 mmol/L and 11.1 mmol/L (120 min) using classification by venous samples as the reference standard. 2. Agreement between OGTT readings after individualised glucose load and weight-banded, standardised glucose load on the capillary device in two separate visits taking place within clinically acceptable time interval using Bland and Altman method and in classification of glycaemic stages by Cohen's Kappa. Measured using baseline (fasting), 0 and 120 minutes at visit 1 and visit 2. Primary (Part B): Agreement between capillary and venous serum proinsulin and C-peptide measures using Bland and Altman plot method and intraclass correlation. Measured at baseline (fasting) and 0 and 120 minutes post glucose load.	—

Measure

Time frame

Secondary (Part A): 1. Sensitivity and specificity of capillary glucose at 5.6 mmol/L, 7.0 mmol/L (fasting), and 7.8 mmol/L and 11.1 mmol/L (120 min) using classification by venous samples as the reference standard. 2. Agreement between OGTT readings after individualised glucose load and weight-banded, standardised glucose load on the capillary device in two separate visits taking place within clinically acceptable time interval using Bland and Altman method and in classification of glycaemic stages by Cohen's Kappa. Measured using baseline (fasting), 0 and 120 minutes at visit 1 and visit 2. Primary (Part B): Agreement between capillary and venous serum proinsulin and C-peptide measures using Bland and Altman plot method and intraclass correlation. Measured at baseline (fasting) and 0 and 120 minutes post glucose load.

—

Countries

Czech Republic, England, Germany, Portugal, United Kingdom

Contacts

Public ContactClaire Scudder

edent1fi_wp3@ndm.ox.ac.uk+44 1865 287664

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 22, 2026