Type 2 Diabetes Mellitus
Conditions
Brief summary
To compare the glucose response in tube fed subjects with type 2 diabetes of a standard enteral product to that of a diabetes-specific enteral product
Interventions
OTHERstandard enteral feeding product
16 hrs daily x 5 days
OTHERDiabetes specific feeding product
16 hrs daily for 5 days
Sponsors
Abbott Nutrition
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* signed and dated informed consent * diagnosis of type 2 diabetes * HbA1c between 7.0 and 9.0% * 18 - 75 years of age * currently receiving a standard enteral product * anticipated duration on tube feeding at least one month * 100% of patient's nutrient and energy needs are anticipated to be met by enteral nutrition support * anticipated life expectancy is more than or equal to 6 months * free of infections * no change in medications within 2 weeks prior to screening that could profoundly affect blood glucose
Exclusion criteria
* composition of either product is inappropriate for the patient due to allergies or intolerance to any ingredient found in the study products * composition of either product is inappropriate for the patient due to protein, fluid or electrolyte restrictions for concomitant conditions * significant cardiovascular event less than or equal to 2 weeks prior to study entry * major surgery less than or equal to 2 weeks prior to study entry * pre-planned surgery during the study period * active malignancy, including melanoma and excluding cutaneous malignancies * severe dementia * known allergies to medical grade adhesives and/or skin disinfectants * taking octreotide * chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV * participation in a concomitant trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mean glucose level | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| fasting capillary blood glucose level;percentage change from baseline in the dose and amount of antihyperglycemic medication(s), including insulin | 24 hours |
Countries
United States
Outcome results
None listed