NCT07666581Not yet recruiting
Influence of the Use of Specific Nutritional Formulas on Time in Range in Patients With Type 2 Diabetes
Influence of the Use of Specific Nutritional Formulas for Diabetes on Time in Range in Patients With Type 2 Diabetes Mellitus With Obesity by Freestyle Continuous Glucose Monitoring
Source: ClinicalTrials.gov · Last updated 24 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 198 (estimated)
- First submitted
- 20 Feb 2026
- Start date
- Aug 2026
- Primary completion date
- Apr 2028
- Lead sponsor
- Hospital Universitario San Ignacio
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07666581
What you commit to
- Study type: Interventional
- Planned participants: 198
- From Aug 2026 to the primary completion date, Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Change in antidiabetic medication in the last 3 months.
- Initiation of treatment with oral or injectable GLP-1 analogues 3 months prior to enrollment.
Other illness
- Acute decompensation of diabetes in the past 3 months.
- History of bariatric surgery or gastrointestinal pathology associated with malabsorption syndromes.
Other
- Pregnancy or lactation or planning to become pregnant during the study period.
- Participation in another clinical trial.
- Use of glucocorticoids or insulin in the past 3 months or planned use in the coming months.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario San Ignacio Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.