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.
Patients over 18 years of age.
Diagnosis of diabetes mellitus type 2.
HbA1c >7% to <11%.
BMI >27 kg/mt2 <35 kg/mt2
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.
Map coordinates are unavailable for these locations. Locations are shown below instead.
ColombiaHospital Universitario San Ignacio
Lead sponsor
Abbott Nutrition
Collaborator