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

NCT07666581 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2026-06-24

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Glucerna

A calorie-restricted diet plan is prescribed (see Table 1). In this group, Glucerna will be prescribed for breakfast and snacks as part of the total calories calculated for each patient's meal plan. Dietary plan prescription of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men.

OTHER

Caloric restriction

Dietary plan prescription of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men.

Sponsors & Collaborators

  • Abbott Nutrition

    collaborator INDUSTRY

  • Hospital Universitario San Ignacio

    lead OTHER

Principal Investigators

  • Ana M Gómez-Medina, Endocrinologyst · Hospital Universitario San Ignacio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-04-30
Completion
2028-12-31

Countries

  • Colombia

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07666581 on ClinicalTrials.gov