A Tube Feeding Study in Malnourished Population With Diabetes

A Prospective, Observational Study, of a High Calorie, High Protein Tube Feeding With Slow Release Carbohydrates and Monounsaturated Fatty Acids (MUFA), in a Malnourished Population With Diabetes

This is a prospective, non-interventional, observational study. Malnourished subjects with diabetes, who are receiving a high calorie, high protein tube feeding with slow release carbohydrates and MUFA by their health care professional (HCP) per standard of care will be enrolled into the study.

Study Overview

• Status: Completed
• Conditions: Malnutrition; Diabetes

• Study Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28047
    • Hospital Gomez-Ulla
  • Málaga, Spain, 29007
    • Centro Médico San Juan de la Cruz
  • Valladolid, Spain, 47003
    • Hospital Clínico Universitario de Valladolid
  • València, Spain, 46014
    • Hospital General Universitario de Valencia
  • La Rioja
    • Logroño, La Rioja, Spain, 26006
      • Hospital San Pedro
  • Málaga
    • Marbella, Málaga, Spain, 29603
      • Hospital Costa del Sol 3095
    • Marbella, Málaga, Spain, 29603
      • Hospital Costa del Sol 3178

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects, men and women who meet all enrollment criteria, will be enrolled from study centers in Spain.

Description

Inclusion Criteria:

• Voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee, prior to any participation in the study
• Considered malnourished, or at risk for malnutrition
• Diagnosed with diabetes mellitus type 1 or 2 and treated with oral hypoglycemic medications and/or exogenous insulin
• Conforms to the requirements set forth on the study product label
• Under the care of a health care professional for malnutrition and has recently been prescribed tube feeding as a sole-source of nutrition by their health care professional
• Free living, residing in a nursing home or admitted to the hospital and has anticipated length of hospital stay > 3 days and < 12 days

Exclusion Criteria:

• Severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
• Cannot safely consume the study product, or known to be allergic or intolerant to any ingredient found in the study product
• Renal or liver failure
• Participates in another study that has not been approved as a concomitant study by AN

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Tube Fed Participants; Individuals with diabetes and malnutrition receiving tube feed as sole source nutrition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight Change	Measured in Kg	Baseline to Study Exit Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Malnutrition Universal Screening Tool (MUST)	HCP completed screening tool	Baseline to Study Exit Week 12
Subjective Global Assessment (SGA)	HCP completed nutrition assessment	Baseline to Study Exit Week 12
Quality of life (EuroQol EQ-5D-5L)	Subject rated health state of 5 dimensions. Each dimension has 5-levels scaled in negative direction resulting in an overall 5-digit number describing the health state; EQ VAS Score 0-100 points scaled in positive direction	Baseline to Study Exit Week 12
Glucose control	HbA1c levels	Baseline to Study Exit Week 12
Body Mass Index	BMI calculated Weight (kg)/Height (m)2	Baseline to Study Exit Week 12
Product Compliance	Product consumption diary	Baseline to Study Exit Week 12
Albumin Levels	Nutrition status parameter collected per standard of care	Baseline to Study Exit Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functionality	Barthel Index of Activities of Daily Living; Subject completed assessment of 10 functions; Sum of scores range from 0-20 scaled in positive direction	Baseline to Study Exit Week 12
Physician Product Satisfaction	Physician Completed Questionnaire; 3 to 5 category responses scaled in negative direction	Baseline to Study Exit Week 12

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Angela M Palmero, MD, Hospital San Pedro de La Rioja

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2018
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Actual): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 23, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Nutrition Disorders; Diabetes Mellitus; Malnutrition
• Other Study ID Numbers: DA14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No