Meal Frequency and Glycemic Control in Individuals With Type 1 Diabetes

Launched by HOSPITAL DE CLINICAS DE PORTO ALEGRE · Apr 11, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how the number of meals people with Type 1 Diabetes (T1D) eat each day affects their blood sugar control. Participants will be asked to follow two different meal plans: one with three meals a day and another with six meals a day, both providing the same total calories. Each meal plan will be followed for three weeks, with a four-week break in between. The goal is to see which meal frequency helps better manage blood sugar levels and reduces fluctuations.

To be eligible for this study, participants need to be adults aged 18 to 60 who have been diagnosed with Type 1 Diabetes for over a year and regularly monitor their blood sugar levels. They should also be comfortable counting carbohydrates in their meals. However, some individuals won't be able to participate, such as those with certain health issues related to diabetes or other medical conditions. If you decide to join, you'll need to keep a record of what you eat and any high or low blood sugar events before starting the meal plans. This trial is not yet recruiting participants, but it aims to provide valuable insights into diet management for those living with T1D.

Gender

ALL

Eligibility criteria

• 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) in the last 12 weeks prior to screening.
• • Treatment with thyroid hormone that has not been maintained at a stable dose in the last 12 weeks prior to screening.
• • History of active substance abuse (including alcohol) in the last year.
• • Serious psychiatric illness: Mood disorders, anxiety disorders, severe psychotic disorders, and personality disorders that are revealed or identified in the clinical evaluation, listed or reported in the medical record, and that have no clinical findings.
• • Predisposition to or diagnosis of eating disorders.
• • Women who are pregnant, intending to become pregnant during the study period, or who are breastfeeding.
• • Hyperglycemia characterized by acute symptoms: polyuria, polydipsia, and/or weight loss in the last 3 months. ● Metabolic and acute complications of diabetes such as ketoacidosis or hyperosmolar coma.
• • Night workers who work after 10 pm.