Evaluation of Glucose Control in Patients With Diabetes

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

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

Study Overview

• Status: Completed
• Conditions: Glycemic Control
• Intervention / Treatment: Other: Usual Diet Group; Other: Group 1 Nutritional Shake; Other: Group 2 Nutritional Shake

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Radiant Research
  • Florida
    • Boca Raton, Florida, United States, 33487
      • MB Clinical Research
    • Pinellas Park, Florida, United States, 33781
      • Radiant Clinical Research
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rocky Mountain Daibetes and Osteoporosis Center
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Joslin Diabetes Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • Health Partners Institute, International Diabetes Center
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Radiant Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual Diet Group; 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; three main meals and two snacks
Experimental: Group 1 Nutritional Shake; 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; 2 servings per day
Experimental: Group 2 Nutritional Shake; 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; 2 servings per day

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutrition Behaviors Self-Reported Outcome Questionnaire	15 Likert scale questions related to diet selection, oral nutritional supplement use, cravings and hunger control	Study Day 1 to Study Day 14
Physical Activity Questionnaire	Adapted from National Health Interview Survey; Subject completed; 3 questions related to description of typical physical activity	Study Day 1
Habitual Snack Timing Questionnaire	Subject completed; 3 questions related to frequency, timing and reason for snacking	Study Day 1
Daily Tracking Log	Subject reported log of sleeping, exercise and eating information	Study Day 1 to Study Day 14
Weight	Measured in kg	Study Day 1 to Study Day 14
Height	Measured in cm	Study Day 1
Waist Circumference	Measured in inches	Study Day 1
Medications	Subject reported medication usage including dose, unit, frequency and reason for use	Study Day 1 to Study Day 14

Collaborators and Investigators

• Sponsor: Abbott Nutrition

Publications and helpful links

General Publications

• Mustad VA, Hegazi RA, Hustead DS, Budiman ES, Rueda R, Maki K, Powers M, Mechanick JI, Bergenstal RM, Hamdy O. Use of a diabetes-specific nutritional shake to replace a daily breakfast and afternoon snack improves glycemic responses assessed by continuous glucose monitoring in people with type 2 diabetes: a randomized clinical pilot study. BMJ Open Diabetes Res Care. 2020 Jul;8(1):e001258. doi: 10.1136/bmjdrc-2020-001258.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2017
• Primary Completion (Actual): February 15, 2018
• Study Completion (Actual): February 15, 2018

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: BL34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No