Influence of the Use of Specific Nutritional Formulas on Time in Range in Patients With Type 2 Di… (NCT07666581) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Influence of the Use of Specific Nutritional Formulas on Time in Range in Patients With Type 2 Diabetes
Colombia198 participantsStarted 2026-08
Plain-language summary
Who can participate?
Individuals may be eligible to join this study if they meet the following criteria:
* Are 18 years or older.
* Have Type 2 diabetes with an A1c level higher than 7%.
* Have a Body Mass Index (BMI) between 27 and 35 (considered overweight or Class 1 obesity).
* Have used a continuous glucose monitor (CGM) successfully in the past.
How the study works:
If eligible individuals decide to join and sign the consent form, a computer will randomly assign them into one of two groups:
The Formula Group: Participants will replace their usual breakfast and one snack with a specific diabetes nutritional drink (Glucerna®).
The Standard Diet Group: Participants will follow a standard low-calorie meal plan without using the nutritional drink.
Both groups will aim for a specific daily calorie goal (1,200-1,500 for women; 1,500-1,800 for men) and will receive expert nutritional counseling.
Monitoring and Follow-up
Over the course of 3 months, close contact will be maintained to support participants:
Every 2 weeks: A nutrition expert will call participants to check on their diet and help with their glucose monitor.
Every month: Participants will meet with the study team in person to review glucose monitor data.
Tests: At the start and end of the study, weight, body composition, blood sugar (A1c), and cholesterol levels will be measured to see how the plans worked.
Who can participate
Age range
18 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:
* Patients over 18 years of age.
* Diagnosis of diabetes mellitus type 2.
* HbA1c \>7% to \<11%.
* BMI \>27 kg/mt2 \<35 kg/mt2
* Current use of continuous glucose monitoring with adherence greater than 70%.
* Access to technology to download data from CGM in a timely manner.
* Ability to follow the study protocol and provide informed consent (Appendix 3).
Exclusion criteria:
* Change in antidiabetic medication in the last 3 months.
* Pregnancy or lactation or planning to become pregnant during the study period.
* Acute decompensation of diabetes in the past 3 months.
* Participation in another clinical trial.
* Use of glucocorticoids or insulin in the past 3 months or planned use in the coming months.
* Initiation of treatment with oral or injectable GLP-1 analogues 3 months prior to enrollment.
* History of bariatric surgery or gastrointestinal pathology associated with malabsorption syndromes.
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.