Status:
COMPLETED
A Tube Feeding Study in Malnourished Population With Diabetes
Lead Sponsor:
Abbott Nutrition
Conditions:
Malnutrition; Diabetes
Eligibility:
All Genders
18+ years
Brief Summary
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 MUF...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 29 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03766620
Start Date
November 29 2018
End Date
July 1 2020
Last Update
July 24 2020
Active Locations (8)
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1
Hospital San Pedro
Logroño, La Rioja, Spain, 26006
2
Hospital Costa del Sol 3095
Marbella, Málaga, Spain, 29603
3
Hospital Costa del Sol 3178
Marbella, Málaga, Spain, 29603
4
Hospital Universitario La Paz
Madrid, Spain, 28046