A Tube Feeding Study in Malnourished Population With Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-29

Study Completion Date

2020-07-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Malnutrition; Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tube Fed Participants

Individuals with diabetes and malnutrition receiving tube feed as sole source nutrition.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No