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

RecruitingOBSERVATIONAL
Enrollment

75

Participants

Timeline

Start Date

March 23, 2023

Primary Completion Date

May 31, 2025

Study Completion Date

September 30, 2025

Conditions
Type 1 DiabetesHypoglycemia
Interventions
OTHER

Mixed Meal Tolerance Test (MMTT)

At either Visit 1 or Visit 2, participants will be given Ensure HP or Fortisip (a drink containing the same amounts of carbohydrates, protein and fats as there would be in a meal; 6ml/kg to a max of 360mls), and have blood samples collected, to measure insulin (C-peptide), glucose, and glucagon, at specific intervals: -10, 0, 30, 60, 90, 120 minutes post meal. This test is used to measure how a participant's beta cells are working to produce insulin after a meal and to check for reactive hypoglycaemia.

OTHER

Arginine Stimulation Test (AST)

At either Visit 1 or Visit 2, and Visit 3, participants will be given a dose of Arginine Hydrochloride (5 g Arginine during 1 min) by intravenous injection, and have blood samples collected to measure insulin (C-peptide), glucose, and glucagon, at specific intervals: -10, 0, 2, 5, 10, 15 and 30 minutes following the Arginine bolus injection. This test is designed primarily to test the maximum insulin secretion capacity of a participant's beta cells.

OTHER

Home Finger Prick Sample

Participants will be provided with a kit to collect an optional home finger prick sample the day after each visit, and return the sample using the prepaid addressed padded envelope provided.

Trial Locations (1)

EX2 5DW

RECRUITING

Royal Devon University Healthcare NHS Foundation Trust, Exeter

All Listed Sponsors
collaborator

Royal Devon and Exeter NHS Foundation Trust

OTHER

lead

University of Exeter

OTHER