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NCT05616273Completed

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

Source: ClinicalTrials.gov · Last updated 19 Dec 2025

Brief summary (registry, in English)

Type 1 diabetes (T1D) results from destruction of insulin producing beta cells by the body's own immune system (autoimmunity) causing an individual to lose the ability to make enough insulin to control their blood sugar levels and need to have insulin injections to lower blood glucose levels. Whilst high blood sugar level is a problem for people with Type 1 diabetes, taking insulin medication to lower sugar levels, delayed meals and exercise can all result in dangerously low blood sugar levels (hypoglycaemia). The biological causes of hypoglycaemia, and ways to prevent it are poorly understood. In non-diabetic individuals, a hormone called glucagon is secreted naturally to raise blood glucose levels but it is unclear why glucagon secretion is impaired during hypoglycaemia in individuals with T1D. The aim of this prospective observational study is to test the relationship between a glucagon stimulation test and risk of hypoglycaemia in T1D. It is hoped this research will establish whether this relationship could be used as a blood test and be a clinically useful biomarker of hypoglycaemia risk and, therefore, directly inform clinical care of people with T1D, particularly those with highest risk of hypoglycaemia. Assessment of beta cell decline has traditionally relied on timed C-peptide measures following a standardised liquid meal known as the mixed meal tolerance test (MMTT). Home finger prick blood spot C-peptide measurement might be a practical, cheap, and non-invasive alternative to a MMTT and would allow regular assessment of beta cell function over time. If proven that this sample type is a robust alternative to the gold standard MMTT venous C-peptide, it would dramatically decrease the cost and participant burden of T1D research into beta cell function.

Status (registry)
Completed
Study type
Observational
Enrollment
62 (actual)
First submitted
7 Nov 2022
Start date
3 May 2023
Primary completion date
28 Jan 2025
Lead sponsor
University of Exeter
NCT number
NCT05616273

What you commit to

  • Study type: Observational
  • Participants enrolled: 62
  • From 3 May 2023 to the primary completion date, 28 Jan 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Any medical condition that, in the opinion of the investigator, would affect the safety of the subject's participation, or validity of results.

Age

  • Age less than 16 year or over 65 years

Other

  • Pregnant or lactating (as this may limit blood sampling and affect T cell function)

Who the study is looking for

  • 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.

Age in the registry: 16 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Devon University Healthcare NHS Foundation Trust
Coordinator of this site? Confirm its status
ExeterUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.