NCT04614168Completed
Maximising Time With a Normal Blood Glucose to Restore the Glucagon Response in Type 1 Diabetes
Can Maximising Time in Range Using Automated Insulin Delivery and a Low Carbohydrate Diet Restore the Glucagon Response to Hypoglycaemic in Type 1 Diabetes?
Source: ClinicalTrials.gov · Last updated 28 Jan 2026
Brief summary (registry, in English)
Almost all people who have had type 1 diabetes for 5 years have a defect in secretion of the hormone Glucagon. This hormone is involved in the body's response to low blood glucose (hypoglycaemia). It works by releasing glucose stores from the liver to bring the blood glucose back to normal. This defect therefore increases the risk of severe hypoglycaemia. The reason for this Glucagon defect in people with Type 1 diabetes is currently unknown. This study aims to look at the Glucagon response to hypoglycaemia in 24 people with type 1 diabetes to ascertain whether tight blood glucose control over a period of time improves this response. The investigators aim to achieve good blood glucose control using new generation Automated Insulin Delivery systems (AIDs). This system is made of: an insulin pump, a continuous glucose monitor (CGM) and an algorithm that allows adjustment of insulin delivery based on the blood glucose readings from the CGM. This is the most up to date technology that there is in the management of type 1 diabetes. However, people using this technology often still have problems with high blood glucose after eating. To ensure a very good blood glucose control participants will also follow a low carbohydrate diet to prevent this blood glucose rise after meals. The Glucagon response to low blood glucose will be measured at zero and eight months using the hyperinsulinaemic hypoglycaemic clamp technique.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 7 Oct 2020
- Start date
- 26 Jul 2021
- Primary completion date
- 22 Sept 2023
- Lead sponsor
- University of Edinburgh
- Diseases
- Type 1 diabetes
- NCT number
- NCT04614168
What you commit to
- Study type: Interventional
- Participants enrolled: 24
- From 26 Jul 2021 to the primary completion date, 22 Sept 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of Diabetic ketoacidosis in the preceding 6 months.
- 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.
- A condition, which in the opinion of the investigator, would put the patient or study at risk
Lab values
- Current use of a non-approved closed loop / AID system or those on a predictive low glucose suspend insulin pump.
- 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
- HbA1c greater than or equal to 75 mmol/mol
Other
- Proliferative retinopathy
- Regular use of real time CGM in the preceding 3 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)
- Unable to adhere to study timetable.
- Unable to give informed consent.
- Pregnancy. We will perform a pregnancy test on all eligible participants at baseline.
Who the study is looking for
- 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
Age in the registry: 21 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Edinburgh Royal Infirmary/University of Edinburgh Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.