Influence of the Use of Specific Nutritional Formulas on Time in Range in Patients With Type 2 Diabetes
1 other identifier
interventional
198
1 country
1
Brief 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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Aug 2026
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2026
CompletedFirst Posted
Study publicly available on registry
June 24, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
June 24, 2026
June 1, 2026
1.7 years
February 20, 2026
June 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time in range
Time in range 70 - 180 mg/dl
3 months
Secondary Outcomes (3)
HbA1c
3 months
Weight
3 months
body composition
3 months
Study Arms (2)
Glucerna
ACTIVE COMPARATORA 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.
Placebo
PLACEBO COMPARATORDietary plan prescription of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men.
Interventions
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.
Dietary plan prescription of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Universitario San Ignaciolead
- Abbott Nutritioncollaborator
Study Sites (1)
Hospital Universitario San Ignacio
Bogotá, Cundinamarca, 111021, Colombia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ana M Gómez-Medina, Endocrinologyst
Hospital Universitario San Ignacio
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2026
First Posted
June 24, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
June 24, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share
The datasets generated during and/or analyzed during the current study are not publicly available due contains clinical data of patients being monitored at the Hospital Universitario San Ignacio but are available from the corresponding author on reasonable request.