NCT03976271

Who might be able to join this trial:

• You are able to give written consent to take part in the study
• You can speak and read Danish (if joining at the Hillerød site) or Dutch (if joining at the Nijmegen site)
• You are managing your diabetes with a basal-bolus insulin routine, either by injections or an insulin pump (this does not apply to group 5)
• Your Body Mass Index (a measure of body weight relative to height) is between 19 and 40
• You are aged between 18 and 80 years old
• Your blood pressure is below 140/90 mmHg (confirm with trial site if unsure)
• You have had diabetes for more than 1 year (this does not apply to group 5)
• Your long-term blood sugar level (HbA1c) is below a certain threshold (confirm with trial site for your specific group)

Group-specific requirements (confirm with trial site which group applies to you):

• Group 1: Your long-term blood sugar level is above a certain higher range
• Group 2: You have reduced ability to notice when your blood sugar is low, based on specific questionnaire scores
• Group 3: You have a normal ability to notice when your blood sugar is low, based on specific questionnaire scores
• Group 4: You have been on insulin treatment for at least 1 year
• Groups 5/6: Your long-term blood sugar level is within a lower range (confirm with trial site)

Who may not be able to join:

• You have a serious medical or mental health condition (other than reduced awareness of low blood sugar) that affects your ability to notice low blood sugar, such as a brain injury, epilepsy, a major heart condition, or an anxiety disorder
• You are currently taking medicines that affect the immune system or antibiotics
• You are taking medicines that affect blood sugar levels, other than insulin, certain diabetes tablets (SGLT-2 inhibitors or metformin)
• You are currently taking antidepressant medicines
• You are pregnant, breastfeeding, or unwilling to use contraception during the trial
• You are currently taking statins (cholesterol-lowering medicines), unless you are able to stop taking them more than 2 weeks before blood samples are taken (confirm with trial site)
• You have had a heart attack, stroke, heart failure, or serious circulation problems in the past 5 years
• You have a condition where your immune system attacks your own body (such as an autoimmune or auto-inflammatory disease)
• You have had any infection in the past 3 months
• You have had any vaccination in the past 3 months
• You have had laser eye treatment for a diabetes-related eye condition in the past 6 months
• You currently have a serious diabetes-related eye condition (proliferative retinopathy)
• You have diabetes-related kidney problems, shown by specific blood or urine test results (confirm with trial site)
• You have a history of pancreas inflammation (pancreatitis) or pancreatic cancer

Important: Always verify eligibility with the trial site directly before applying.