Retrospective, Multicenter, Single-arm, Observational Study, With Data From Patients With T2DM With Malnutrition or at Risk, Who Were Prescribed Resource® Diabet Plus as a Hypercaloric and Hyperproteic Specific Formula for Patients With T2DM

NCT06866366 | Completed

• 1 other identifier: NES-2023-152-RET-DP
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 4

Brief Summary

This retrospective multicentre study aims to provide real-world evidence of the effectiveness of Resource® Diabet Plus as supplementation tool for T2DM patients with malnutrition or at risk of malnutrition, under conditions of routine clinical practice in Spain.

Conditions

Malnourished Elderly; Malnourishment; Diabetes Mellitus Type 2

Keywords

DRM; Disease - realted malnutrition; Diabetes-specific formula; Metabolic control; Oral nutritional supplementation; DSF; T2D

Outcome Measures

Primary Outcomes (1)

• Glycaemic control

  Changes in HbA1c, meaning a percentage less than 7, good glycaemic control.

  In 12 and 24 weeks from baseline visit

Secondary Outcomes (4)

• Metabolic control

  In 12 and 24 weeks from baseline visit

• Nutritional and functional status

  In 12 and 24 weeks from baseline visit

• Gastrointestinal tolerance

  In 12 and 24 weeks from baseline visit

• Healthcare resource use and associated costs

  During 24 weeks from baseline visit

Study Arms (1)

Patients with T2DM with malnutrition or at risk, who were prescribed: Resource® Diabet Plus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetic patient with malnutrition or at risk of malnutrition, treated for it in hospitals of the national network who have been prescribed 1-2 bottles/day of Resource® Diabet Plus

You may qualify if:

• Patients ≥ 18 years.
• Outpatients or hospitalised patients, at discharge with a diagnosis of type 2 Diabetes.
• Patients at risk of malnutrition detected by validated screening tools or with DRM diagnosed by GLIM criteria.
• Patients who have been prescribed 1-2 bottles/day of Resource® Diabet Plus following the conditions of use of its technical data sheet, in the last 2 years, with at least 24 weeks of evolution recorded in the clinical history.
• Patients who have Hb1Ac data in the medical record on the index date and during evolution.

You may not qualify if:

• Pregnant or breastfeeding women.
• Patients who required any other type of nutritional supplementation during the study period (parenteral/enteral).
• Patients with severe renal insufficiency (glomerular filtration rate \< 30mL/min/1.73m2) at the time of selection.

Sponsors & Collaborators

• Outcomes'10: lead
• Nestlé Health Science Spain: collaborator

Study Sites (4)

Hospital Universitario Insular de Gran Canaria

Las Palmas de Gran Canaria, Spain

Location

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Spain

Location

Hospital Universitario Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Spain

Location

MeSH Terms

Conditions

Malnutrition; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: April 23, 2025
• Primary Completion: July 13, 2025
• Study Completion: July 13, 2025
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)