Could a High-Tech insulin system and Low-Carb diet fix a dangerous diabetes problem?
NCT ID NCT04614168
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether using an automated insulin delivery system (a smart insulin pump and continuous glucose monitor) along with a low-carbohydrate diet can help restore the body's natural glucagon response to low blood sugar in people with type 1 diabetes. The glucagon response is often lost after years of diabetes, raising the risk of severe hypoglycemia. Researchers will measure glucagon levels during controlled low blood sugar at the start and after 8 months of tight glucose control in 24 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Automated insulin delivery system and low carbohydrate diet
- What this could lead to
- If successful, this could point toward a way to restore the body's natural defense against dangerously low blood sugar in type 1 diabetes.
- What could go wrong
- This is a small, early-stage study with only 24 people, so results may not apply to everyone. It tests a theory, not a proven treatment, and the diet and technology may be hard to maintain long-term.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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24 people
The number who actually took part.
- Started
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Jul 2021
- Finished
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Dec 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Edinburgh Royal Infirmary/University of Edinburgh
Edinburgh, United Kingdom
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Other studies related to the condition(s) this trial covers.
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