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

A randomized controlled clinical trial will be conducted with two parallel groups, which will include patients over 18 years of age with type 2 DM, HbA1c > 7%, and grade 1 obesity (BMI >27 kg/m2 and <35 kg/m2), who have previously used continuous glucose monitoring (CGM) with adherence greater than 70%, and who are able to follow the study protocol.

After signing the informed consent, REDcap® will be used to computer-generate the random sequence for group assignment; the intervention group will use a specific nutritional formula for diabetes (FNED) (Glucerna®) (Appendix 1) as a replacement for breakfast and snack to achieve targets of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men, and the control group will continue to be prescribed a low-calorie diet of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men without the use of FNED for a period of 3 months. Both groups will receive nutritional counseling according to the diabetes support and self-care education plan.

CGM, body composition, and baseline paraclinical variables will be collected, and every 14 days, adherence to dietary treatment will be verified by telephone using a 24-hour multi-step reminder with advice from a dietary team, and correct use of the device will be verified. CGM records are reviewed in person monthly using the LibreView" platform. CGM data, body composition and HbA1c, total cholesterol, HDL, LDL, baseline triglycerides will be analyzed at 3 months of follow-up.

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.