Type 1 Diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
This is a double blind, crossover, placebo controlled, exploratory physiological study. It is a single site study on 18 participants with T1D, who will be recruited over a 12 month period. The aim is
Sponsors
Leona M. and Harry B. Helmsley Charitable Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants with T1D with C-peptide levels less than 100pmol/L 2. Age 21-65 years 3. T1D for 5 years or more
Exclusion criteria
Exclusion criteria: 1. Proliferative retinopathy 2. History of Diabetic ketoacidosis in the preceding 6 months 3. Severe hypoglycaemic episode requiring external assistance in the preceding 6 months 4. History of Haemophilia, Cystic Fibrosis, pancreatic disease or complete pancreatectomy, ischaemic heart disease, cardiac arrhythmia, epilepsy or hypoglycaemia induced seizure 5. History of severe reaction or allergy to adhesive necessary to this study 6. Unable to adhere to study timetable 7. Unable to give informed consent 8. Pregnancy or planning pregnancy. We will perform a pregnancy test on all eligible participants at baseline 9. Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas). These may lower insulin requirements and predispose to diabetic ketoacidosis 10. Hypothyroidism 11. Concurrent use of medication that may affect blood glucose such as SSRIs 12. Inability to understand or speak English. Time is of the essence during the clamp procedure, there is no time for translation 13. A condition, which in the opinion of the investigator, would put the patient or study at risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucagon, measured during insulin clamp procedures | — |
Secondary
| Measure | Time frame |
|---|---|
| Cortisol, Adrenaline, Noradrenaline, Insulin and Glucose concentrations, measured during insulin clamp procedures | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactShareen Forbes
Outcome results
None listed