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
Launched by OUTCOMES'10 · Mar 7, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at the effectiveness of a special nutritional drink called Resource® Diabet Plus for people with Type 2 Diabetes who are malnourished or at risk of malnutrition. The study will gather information from patients who have used this drink in real-life situations in Spain, to see how well it helps manage their health and nutrition over time.
To participate in the trial, individuals must be at least 18 years old and have a diagnosis of Type 2 Diabetes. They should also be identified as at risk of malnutrition or diagnosed with malnutrition by specific criteria. Participants will need to have been prescribed 1-2 bottles of the drink each day for at least six months and have relevant health data recorded in their medical history. However, pregnant or breastfeeding women, those with severe kidney issues, or patients receiving other nutritional support will not be eligible. This study aims to provide valuable insights into how this nutritional formula can support the health of those living with Type 2 Diabetes.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • 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.
About Outcomes'10
outcomes'10 is a clinical trial sponsor dedicated to advancing medical research through innovative study designs and robust data analysis. With a focus on optimizing patient outcomes, outcomes'10 collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct high-quality clinical trials across various therapeutic areas. Their commitment to ethical practices and patient safety is coupled with a strong emphasis on transparency and scientific rigor, ensuring that the findings contribute meaningfully to the medical community and improve healthcare delivery.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported