Diabetes nutrition drink versus standard low-calorie diet in type 2 diabetes with overweight
Compares a diabetes nutrition drink with a standard diet in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: Influence of the Use of Specific Nutritional Formulas on Time in Range in Patients With Type 2 Diabetes
Key facts
- Where
- Bogotá, ColombiaSee the site
Where in Colombia
- Hospital Universitario San IgnacioBogotá, ColombiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital Universitario San Ignacio
- Trial code
- NCT07666581
- Record updated
- 24 June 2026
- Original description
Who can participate?Read full original descriptionShow less
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
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.
Inclusion: 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: Change in antidiabetic medication in the last 3 months; Initiation of treatment with oral or injectable GLP-1 analogues 3 months prior to enrollment; Acute decompensation of diabetes in the past 3 months; History of bariatric surgery or gastrointestinal pathology associated with malabsorption syndromes; 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.