Maximising Time With a Normal Blood Glucose to Restore the Glucagon Response in Type 1 Diabetes
Type 1 Diabetes, Type 1 Diabetes Mellitus With Hypoglycemia, Hypoglycemia
About this trial
This is an interventional basic science trial for Type 1 Diabetes focused on measuring Type 1 diabetes, Hypoglycaemia, Hypoglycemia, Glucagon, Insulin, Low carbohydrate diet, Stable isotope
Eligibility Criteria
Inclusion Criteria:
- Participants with Type 1 diabetes with C-peptide levels less than 200pmol/L.
- Type 1 diabetes for 5 years or more.
- HbA1c greater than or equal to 53 mol/mol.
- Normal renal function.
- Normal thyroid function.
- Gold Score 4-7 (indicating impaired awareness of hypoglycaemia)
- Willingness to monitor blood ketones daily.
- Use of freestyle libre device is permitted at study entry and may be continued in participants in group 1
Exclusion Criteria:
- Current use of a non-approved closed loop / AID system or those on a predictive low glucose suspend insulin pump.
- Proliferative retinopathy
- Regular use of real time CGM in the preceding 3 months.
- History of Diabetic ketoacidosis in the preceding 6 months.
- Severe hypoglycaemic episode requiring external assistance in the preceding 6 months.
- Inability to safely use technology used in this study (e.g. impaired vision, memory or dexterity that prevents safe operation of CGM or insulin pump.)
- Inability to support the technology requirements for the study (e.g. unable to upload study device at home)
- History of Haemophilia, Cystic Fibrosis, pancreatic disease or complete pancreatectomy, ischaemic heart disease, epilepsy or hypoglycaemia induced seizure
- History of severe reaction or allergy to adhesive necessary to this study.
- Unable to adhere to study timetable.
- Unable to give informed consent.
- Pregnancy. We will perform a pregnancy test on all eligible participants at baseline.
- 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.
- Concurrent use of medication that may affect blood glucose such as SSRIs
- A condition, which in the opinion of the investigator, would put the patient or study at risk
- HbA1c greater than or equal to 75 mmol/mol
Sites / Locations
- Edinburgh Royal Infirmary/University of EdinburghRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Group 1 - Standard Care
Group 2- Automated insulin delivery and low carbohydrate diet
This group will continue on their standard diabetes care. They will be required to undergo three periods of blinded continuous glucose monitoring each lasting 20-days at: baseline, 4 months and 8 months. Participants in this group will undergo a hyperinsulinaemic hypoglycaemic clamp study at baseline and 8 months. They will also complete quality of life and diabetes treatment questionnaires at baseline and 8 months.
This group will be placed on an automated insulin delivery system: Tandem t:slim x2 insulin pump with Control IQ technology and Dexcom G6 continuous glucose monitor. They will also be asked to follow a low-carbohydrate diet of 30-40g of carbohydrate per main meal. At baseline they will have a 20-day period of blinded continuous glucose monitoring. Participants in this group will undergo a stepped hyperinsulinaemic hypoglycaemic clamp study at baseline and 8 months. They will also complete quality of life and diabetes treatment questionnaires at baseline and 8 months.