Evaluating Use of Continuous Glucose Monitors in a Short-term 2x2-Crossover Study

Study Overview
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Brief Summary
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This 5-week, double-blind, placebo-controlled, 2x2 crossover pilot study investigate the potential of collecting robust, real-time clinical study measures of glucose levels using Abbott Freestyle Libre Continuous Glucose Monitoring devices associated with a smartphone application

Detailed Description
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The goal of this study is to characterize the performance of a Continuous Glucose Monitoring System in medical food studies. The Freestyle Libre Glucose Sensors will be used to follow subject's 8-day glucose trajectories over the course of a 5-week, double-blind, placebo-controlled, 2x2 crossover, medical-food experiment. The medical food has been designed to increase butyrate production and promote the health of the colonic mucin layer.

Official Title
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Evaluating Use of Continuous Glucose Monitors in a Short-term 2x2-Crossover Study

Conditions
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Diabetes Type 2, Diabetes Mellitus

Intervention / Treatment
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* Other: WB-011
* Other: Placebo
* Device: Continuous Glucose Monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 to 75 years of age If female, must meet all the following criteria: Not pregnant or breastfeeding If of childbearing potential (including peri-menopausal women who have had a menstrual period within one year) must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as double barrier methods [male condom with spermicide, with or without cervical cap or diaphragm], implants, injectable or oral contraceptives [must have been using for at least the last 3 months], some intrauterine contraceptive devices, tubal ligation, or in an established relationship with a vasectomized partner) during the entire duration of the study Must be able to read, understand, and sign the informed consent forms (ICF) and, when applicable, an authorization to use and disclose protected health information form (consistent with Health Insurance Portability and Accountability Act of 1996 [HIPAA] legislation as modified in 2013) Must be able to communicate with the investigator, and understand and comply with protocol requirements Must be able to wear a CG patch and perform a scan no less than once every 8 hours for the duration of the sensor periods. Exclusion Criteria: Subjects who plan to use antibiotic, antifungal, antiparasitic, or antiviral treatment during the study Subjects using a proton pump inhibitor must be on a stable dose that will be maintained throughout the study period Subjects who plan to travel outside the United States during the projected study period Subjects who have received an experimental drug within 30 days prior to study entry Subjects with known milk, peanut, or tree nut allergies Subjects who have been diagnosed with a sexually transmitted disease including, but not limited to, HIV, syphilis, herpes, gonorrhea, hepatitis A, hepatitis B, and hepatitis C History of any surgery on the gastrointestinal tract except appendectomy and cholecystectomy Subjects with any condition that the investigator deems as a sound reason for disqualification from enrollment into the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WB-011<br>3 capsules administered twice daily with morning and evening meal for 2 weeks | Other: WB-011<br>* WB-011 medical food product.<br>Device: Continuous Glucose Monitor<br>* Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.<br>|
| Placebo Comparator: Placebo<br>3 capsules administered twice daily with morning and evening meal for 2 weeks | Other: Placebo<br>* Placebo Capsules identical to those containing WB-011.<br>Device: Continuous Glucose Monitor<br>* Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature as a Source of Unwanted Variation When Using Freestyle Libre Glucose Sensors | Temperature impacts the glucose level recorded by the Freestyle Libre glucose sensors. The thermostat of the Freestyle Libre glucose sensors can be assessed. | Through study completion, an average of 5 weeks | 
| 2-hour Interstitial Glucose Area Under the Curve (AUC) | Change in area under interstitial glucose concentration versus time curve (AUC) during standardized self-administered 2-hour Meal Tolerance Test. | Change from baseline to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Mass | Weight measured via Scale | Change from baseline to 2 weeks | 
| Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration | Fecal quantitative PCR of product strain will be measured throughout the study if subject provide stool samples. Mass Fraction is measured and the delta between the start and end of each period is computed. | Change from baseline to 2 weeks | 
| Expected Lifespan of Continuous Glucose Monitoring (CGM) Sensors | To measure the lifespan of CGM sensors, we recorded how many sensors were worn per participant during the study. Sensors were replaced either at the end of the recommended 10-day period, or when they were accidentally removed. | Through study completion, an average of 5 weeks | 
| Number of Pictures Per Day | Average number of pictures per day using the smartphone application per period, used to measure study fatigue. | 2 weeks, (First intervention or second intervention) | 
| Time Between CGM-sensor Scans | Average number of hours between CGM-sensor scans using the smartphone application during the study period. The subjects were instructed to scan at least every eight hours because the CGM-sensor does not save the data after eight hours without scanning. | 2 weeks, (First intervention or second intervention) | 
| CGM-Smartphone Usability Feedback | Questionnaire to assess usability of the CGM-sensor using the smartphone application. Question was: Would you recommend others to a study like this? On a scale of 1-10 with 1 being no and 10 being absolutely | Through study completion, an average of 5 weeks. |