WithdrawnNot Applicable

Exogenous Ketones in People With Type 1 Diabetes

Stopped: Prioritization of other projects

0Started 2023-08

Plain-language summary

The aim of this pilot study is to investigate the metabolic effects of exogenous ketone ester food supplements, by assessing the change in blood acid-base balance, and the level of blood beta-hydroxy-butyrate in people with type 1 diabetes during resting conditions.

Who can participate

Age range

18 Years – 45 Years

Sex

MALE

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: * Type 1 diabetes for \>1 year * Male and female aged 18-45 years old * HbA1c \<8.5% (69 mmol/mol) based on analysis from the central laboratory unit of Bern University Hospital * Using either continuous subcutaneous insulin infusion or multiple daily injections * Wearing a continuous glucose monitor (CGM) or flash glucose monitor (fGM) * Written informed consent Exclusion Criteria: * Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the results as judged by the investigator * Current treatment with drugs known to interfere with metabolism e.g. systemic corticosteroids, statins, SGLT2 inhibitors, GLP1 agonists * Relevant diabetic complications as judged by the investigator * Body mass index \> 30 kg/m2 * Uncontrolled hypertension (\>180/100 mmHg)

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

Change in venous blood pH

Timeframe: Over a 3 hour period from baseline following ingestion of a ketone ester drink in people with type 1 diabetes.

Trial details

NCT IDNCT04487678

SponsorInsel Gruppe AG, University Hospital Bern

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11

View on ClinicalTrials.gov More Ketosis, Diabetic trials