Stimulated Glucagon As a Biomarker of Hypoglycemic Risk in Type 1 Diabetes

Launched by UNIVERSITY OF EXETER · Nov 7, 2022

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ClinConnect Summary

This clinical trial is studying how a hormone called glucagon can help predict the risk of low blood sugar (hypoglycemia) in people with Type 1 diabetes (T1D). In T1D, the body cannot produce enough insulin, which is necessary to control blood sugar levels. While insulin helps lower high blood sugar, factors like missed meals or exercise can lead to dangerous drops in blood sugar. The researchers want to see if a glucagon stimulation test can serve as a reliable blood test to identify people at higher risk of hypoglycemia, which could improve their care and safety.

To participate in this study, individuals must be between 16 and 65 years old, diagnosed with Type 1 diabetes, and currently using insulin. They should also have a known urine C-peptide status, which helps assess their beta cell function. Participants will undergo tests to measure their glucagon levels and may have their C-peptide levels assessed in a less invasive way, which could make future research easier and more affordable. It's important to note that pregnant or breastfeeding individuals and those with certain medical conditions may not be eligible for this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Clinical diagnosis of Type 1 diabetes
• • Insulin treated
• • Known urine C-peptide status (using Urinary C-Peptide Creatinine Ratio \[UCPCR\], positive/negative defined by UCPCR 0.2nmol/mmol cut-off)
• • Age 16-65 years inclusive
• • Able and willing to provide informed consent/assent.
• Exclusion Criteria:
• • Age less than 16 year or over 65 years
• • Pregnant or lactating (as this may limit blood sampling and affect T cell function)
• • Any medical condition that, in the opinion of the investigator, would affect the safety of the subject's participation, or validity of results.