Meal Frequency and Glycemic Control in Individuals With Type 1 Diabetes (NCT06934707) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Meal Frequency and Glycemic Control in Individuals With Type 1 Diabetes
Brazil27 participantsStarted 2025-04-20
Plain-language summary
The goal of this clinical trial is to examine the effect of 3 versus 6 daily meals of isocaloric diets on glycemic control and variability in individuals with type 1 diabetes. Participants will be randomized in a crossover clinical trial and will receive two different types of isocaloric diet interventions, in 3 meals/day (calorie distribution: 30% at breakfast, 40% at lunch and 30% at dinner) or 6 meals/day (calorie distribution: 20% at breakfast, 10% at morning snack, 30% at lunch, 10% at afternoon snack, 25% at dinner and 5% at evening snack), for three weeks, with a 4-week washout period between diets.
Who can participate
Age range
18 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:
* • Adults (18 to 60 years old) with a medical diagnosis of type 1 diabetes mellitus
* Individuals who perform carbohydrate counting
* Individuals diagnosed \> 12 months ago
* Perform daily glycemic control using a blood glucose monitor or use of a glucose sensor
* Have the ability to understand and be able to adhere to the proposed interventions.
* Complete a detailed 3-day food record for one week prior to the intervention and record episodes of hypoglycemia (\<70 mg/dL) and hyperglycemia (\>180 mg/dL)
* Able and willing to provide written informed consent and comply with the requirements of the study protocol.
Exclusion Criteria:
* Individuals with glycated hemoglobin ≥ 11%
* Individuals who are using NPH insulin
* Retinopathy with vision deficit that limits the activities proposed in the disciplines.
* Individuals with gastrointestinal disease such as celiac disease, Crohn's disease and Irritable Bowel Syndrome (IBS)
* History of bariatric surgery
* That you are following a carbohydrate, protein and/or fat restriction diet
* Individuals with BMI ≥ 40kg/m2
* Chronic kidney disease with estimated glomerular filtration \<30mL/min per 1.73 m2.
* Liver failure or chronic viral hepatitis
* Active or progressive neurodegenerative disease
* Use of medications that affect glucose metabolism (corticosteroids and immunosuppressants) or cause weight loss. ● Treatment with weight-reducing agents (e.g., orlistat, sibutramine, topiramate, liraglutide)…
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.