Evaluation of Glucose Control in Patients With Diabetes

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

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

Conditions
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Glycemic Control

Intervention / Treatment
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* Other: Usual Diet Group
* Other: Group 1 Nutritional Shake
* Other: Group 2 Nutritional Shake


Participation Criteria
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Eligibility Criteria
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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 Active malignancy, excluding carcinoma in-situ of the cervix, cutaneous malignancies (basal cell carcinoma, squamous cell carcinoma, except melanoma) Chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis A, B or C, or HIV History of bariatric surgery including gastric balloon; history of gastrointestinal disease (e.g., crohns, colitis, celiac) or intestinal surgery that can interfere with consumption/digestion/absorption of study product Habitually engages in strenuous exercise (e.g., high intensity aerobic exercise; including heavy physical labor), duration of 1 hour or longer, 3 or more times per week Known to be allergic or intolerant to any ingredient found in the study products Currently taking any medications, herbals, or dietary supplements, other than allowed medications, during the past 4 weeks that could profoundly affect (in the opinion of the PI or study physician) blood glucose or appetite Eating disorder, severe dementia or delirium, 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 Participant in a concomitant AN trial or trial of a nonregistered drug (or is within the 30 day follow-up period for such a trial) or that otherwise conflicts with this study

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Usual Diet Group<br>Instructed to continue to maintain a diet pattern of three main meals (breakfast, lunch and dinner) with two daily snacks including a usual snack (of their own choosing) mid-morning and a usual snack (of their own choosing) mid-afternoon. | Other: Usual Diet Group<br>* three main meals and two snacks<br>|
| Experimental: Group 1 Nutritional Shake<br>Instructed to consume one nutrition shake instead of their usual breakfast and consume the second nutrition shake for their mid-afternoon snack. | Other: Group 1 Nutritional Shake<br>* 2 servings per day<br>|
| Experimental: Group 2 Nutritional Shake<br>Instructed to consume one Study Shake instead of their usual breakfast and the second Study Shake for the second snack before bed-time. | Other: Group 2 Nutritional Shake<br>* 2 servings per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interstitial Glucose Response | Change versus baseline phase | Study Day 1 to Study Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial Glucose | Change in daily total glucose | Study Day 1 to Study Day 14 |