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Could a High-Tech insulin system and Low-Carb diet fix a dangerous diabetes problem?

NCT ID NCT04614168

Knowledge-focused Sponsor: University of Edinburgh Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

24 people

The number who actually took part.

Started

Jul 2021

Finished

Dec 2025

Lead sponsor

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

21 to 65 years

Sex

Anyone

Healthy volunteers

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

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.

hypoglycemia Insulin Resistance type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Glucagon deficiency Hypoglycemia Hypoglycemia unawareness Insulin hypoglycemia Type 1 diabetes Type 1 diabetes mellitus with hypoglycemia

Contacts and locations

Locations

  • Edinburgh Royal Infirmary/University of Edinburgh

    Edinburgh, United Kingdom

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