Low-carbohydrate Diet in Children with Type 1 Diabetes (NCT05078658) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Low-carbohydrate Diet in Children with Type 1 Diabetes
Czechia35 participantsStarted 2021-09-22
Plain-language summary
The primary aim of this pilot study is to test whether low-carbohydrate diet (LCD) instituted in children/adolescents with type 1 diabetes (T1D) can improve their disease control. The primary objective of the trial is the change in continuous glucose monitoring time in target range 3.9-10.0 mmol/l (TIR) in a 5-week period on LCD as opposed to a 5-week period on recommended carbohydrate diet (RCD).
Secondary objectives are:
Changes in immune parameters during the LCD period; Differences in fecal microbiome during the LCD period; Differences in fecal, serum and urine metabolome during the LCD period;
Who can participate
Age range
6 Years – 20 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:
* T1D diagnosed according to the ADA (American Diabetes Assocciation) criteria
* T1D duration for at least 1 year prior to the intervention
* continuous glucose monitor (CGM) worn \> 70% time in the month prior to the intervention
Exclusion Criteria:
* last HbA1c \< 40 or \> 70 mmol/mol
* subject has celiac disease
* daily average carbohydrate intake \< 130 g/day from 14 days food record prior to the intervention
* any concomitant disease possibly affecting glucose control
* any chronic medication possibly affecting glucose control
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
Change in continuous glucose monitoring time in target range (3.9-10.0 mmol/l) during the LCD period compared to the RCD period