Evaluating Use of Continuous Glucose Monitors in a Short-term 2x2-Crossover Study
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: WB-011 3 capsules administered twice daily with morning and evening meal for 2 weeks |
Other: WB-011
WB-011 medical food product.
Device: Continuous Glucose Monitor
Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
|
| Placebo Comparator: Placebo 3 capsules administered twice daily with morning and evening meal for 2 weeks |
Other: Placebo
Placebo Capsules identical to those containing WB-011.
Device: Continuous Glucose Monitor
Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
|
Outcome Measures
Primary Outcome Measures
- Temperature as a source of unwanted variation when using Freestyle Libre glucose sensors [Through study completion, an average of 5 weeks]
Temperature recorded by the thermostat of the Freestyle Libre glucose sensors
- 2-hour interstitial glucose AUC [2 week: start to end of each arm]
Change in area under plasma glucose concentration versus time curve (AUC) during standardized 3-hour Meal Tolerance Test Change in area under interstitial glucose concentration versus time curve (AUC) during standardized self-administered 2-hour Meal Tolerance Test
Secondary Outcome Measures
- Change in body mass [2 week: start to end of each arm]
Weight measured via Scale
- Change in fecal quantitative PCR measures of probiotic strain concentration [2 week: start to end of each arm]
fecal quantitative PCR of product strain will be measured throughout the study if subject provide stool samples
- Expected lifespan of CGM sensors [Through study completion, an average of 5 weeks]
Time before Freestyle Libre sensor stops recording blood glucose concentration
- Number of pictures per day [Through study completion, an average of 5 weeks]
Number of pictures per day using the smartphone application
- Time between CGM-sensor scans [Through study completion, an average of 5 weeks]
Time between CGM-sensor scans using the smartphone application. After eight hours without scanning, the CGM-sensor does not save the data, thus the data is lost. The subjects were instructed to scan at least every eight hours, so the time between scans can be used to estimate compliance.
- CGM-sensor usability feedback [up to 7 weeks]
Questionnaire to assess usability of the CGM-sensor using the smartphone application
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age: 18 to 75 years of age
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If female, must meet all the following criteria:
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Not pregnant or breastfeeding
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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
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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)
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Must be able to communicate with the investigator, and understand and comply with protocol requirements
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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:
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Subjects who plan to use antibiotic, antifungal, antiparasitic, or antiviral treatment during the study
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Subjects using a proton pump inhibitor must be on a stable dose that will be maintained throughout the study period
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Subjects who plan to travel outside the United States during the projected study period
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Subjects who have received an experimental drug within 30 days prior to study entry
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Subjects with known milk, peanut, or tree nut allergies
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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
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History of any surgery on the gastrointestinal tract except appendectomy and cholecystectomy
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Subjects with any condition that the investigator deems as a sound reason for disqualification from enrollment into the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pendulum Therapeutics Inc | San Francisco | California | United States | 94107 |
Sponsors and Collaborators
- Pendulum Therapeutics
Investigators
- Principal Investigator: Chief Technical Officer, PhD, Pendulum Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WB01-205