Maximising Time With a Normal Blood Glucose to Restore the Glucagon Response in Type 1 Diabetes (NCT04614168) | Clinical Trial Compass
CompletedNot Applicable
Maximising Time With a Normal Blood Glucose to Restore the Glucagon Response in Type 1 Diabetes
United Kingdom24 participantsStarted 2021-07-26
Plain-language summary
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.
Who can participate
Age range
21 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Concurren…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Change in Plasma Glucagon Levels (Pmol/L) Measured During Normoglycaemic and Hypoglycaemia
Timeframe: Clamp 1 at baseline and clamp 2 at 8 months