Clinical Trial

Influence of the Use of Specific Nutritional Formulas on Time in Range in Patients With Type 2 Diabetes

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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.
Trial Details
NCT Number NCT07666581
Lead Sponsor Hospital Universitario San Ignacio
Collaborators: Abbott Nutrition
Conditions Type 2 Diabetes, Obesity & Overweight, Time in Range
Enrollment 198 participants
Start Date 2026-08
Primary Completion 2028-04 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-24