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New study hopes to predict dangerous low blood sugar in type 1 diabetes

NCT ID NCT05616273

Knowledge-focused Sponsor: University of Exeter Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 62 people with type 1 diabetes to see if a test that measures the hormone glucagon can predict the risk of dangerously low blood sugar (hypoglycemia). Participants drank a special liquid meal or received an arginine injection to stimulate glucagon release, and their blood sugar levels were tracked. The goal is to develop a simple blood test that could help doctors identify those at highest risk for hypoglycemia and improve their care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple blood test to predict hypoglycemia risk in people with type 1 diabetes, helping doctors tailor care.
What could go wrong
This is a small observational study, not a treatment trial. The findings may not translate into a reliable clinical test or benefit all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

62 people

The number who actually took part.

Started

May 2023

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

75 individuals with long duration T1D, identified from participation in the TIGI study (UK IRAS ID: 141756, REC Number: 13/SW/0312), with consent to be contacted for future research. The TIGI participants have a clinical diagnosis of T1D, were on insulin from diagnosis and, if BMI was \>30, were autoantibody positive. We will aim to recruit 50 people with undetectable C-peptide and 25 with detectable C-peptide. The selection of people with absent C-peptide allows a secondary analysis focussed on stimulated glucagon without any potential interaction with endogenous insulin secretion. It also focusses on a group of people known to be at high hypoglycaemia risk due to lack of endogenous insulin.

Ages

16 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hyperglycemia hypoglycemia type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypoglycemia Type 1 diabetes

Contacts and locations

Locations

  • Royal Devon University Healthcare NHS Foundation Trust

    Exeter, Devon, EX2 5DW, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.