A Pilot Study to Evaluate Glucose Control in Patients With Type 2 Diabetes

Abbott Nutrition8 sites in 1 country125 target enrollmentFebruary 6, 2017

ConditionsGlycemic Control

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Glycemic Control
Sponsor: Abbott Nutrition
Enrollment: 125
Locations: 8
Primary Endpoint: Interstitial Glucose Response
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A randomized, multicenter, open-labeled, parallel, three group pilot study to evaluate the impact of a diabetes-specific nutritional shake on glucose control.

Registry

clinicaltrials.gov

Start Date

February 6, 2017

End Date

February 15, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Type 2 diabetes as evidenced by the use of metformin, thiazolidinones, or sulfonylureas, alone or in combination, with constant dose for a least 2 months prior to Screening and is able to maintain medication dose throughout the duration of the study
•A1C ≥ 7.0% and ≤ 10.0%
•Follows a consistent eating pattern of 3 main meals with snacks
•BMI ≥ 25.0 and ≤ 40.0 kg/m2
•Stable body weight for the past 2 months prior to Screening Visit
•If on thyroid medication or hormone replacement therapy, dose been has been constant for at least 2 months prior to Screening Visit
•If taking vitamin C supplement \>60 mg/d, is willing to discontinue throughout the duration of the study
•Willing to take non-aspirin pain relievers through the duration of the study
•Voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.

Exclusion Criteria

•Not taking oral anti-hyperglycemic medications (e.g., controlled by diet); is taking other oral anti-hyperglycemic medications other than metformin, thiazolidinones, or sulfonylureas; or on injectable medications (e.g., exenatide, insulin) for glucose control
•History of diabetic ketoacidosis
•History of metabolic/endocrine (other than diabetes), hepatic, or significant renal disease
•Follows a non-typical eating pattern, such as very low carbohydrate diet, strict vegetarianism
•Currently using diabetes-specific nutritional product(s), defined as more than one eating occasions per week
•Non-typical or erratic sleep-wake pattern, such as nightshift worker, chronic insomnia
•Pregnant as confirmed via urine pregnancy test, attempting to conceive or not willing and able to practice birth control during the study duration (only applicable to female subjects)
•Skin lesions, hyperhidrosis, eczema, psoriasis, scarring, tattoos, redness, infection or edema at the application sites that in the opinion of the study investigator or study physician could interfere with device placement or the accuracy of interstitial glucose measurements
•X-ray, MRI or CT appointment scheduled during the period of study participation, and the appointment cannot be rescheduled for a time before study participation starts or after study participation ends
•Current infection (requiring medication or which might be expected to require hospitalization); has had inpatient surgery, or corticosteroid treatment (excluding topical creams) in the last 3 months or antibiotics in the last 3 weeks prior to Screening Visit