Evaluating Use of Continuous Glucose Monitors in a Short-... | NCT04424888

NCT04424888

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
WB-011	Experimental	3 capsules administered twice daily with morning and evening meal for 2 weeks	Other: WB-011 Device: Continuous Glucose Monitor
Placebo	Placebo Comparator	3 capsules administered twice daily with morning and evening meal for 2 weeks	Other: Placebo Device: Continuous Glucose Monitor

Name	Type	Description	Arm Group Labels	Other Names
WB-011	Other	WB-011 medical food product.	WB-011
Placebo

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Eligibility Module

Eligibility Criteria

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

Name	Affiliation	Role
Chief Technical Officer, PhD	Pendulum Therapeutics	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Pendulum Therapeutics Inc		San Francisco	California	94107	United States

PubMed Identifier	Type	Citation	Retractions
33661120	Derived	Roux de Bezieux H, Bullard J, Kolterman O, Souza M, Perraudeau F. Medical Food Assessment Using a Smartphone App With Continuous Glucose Monitoring Sensors: Proof-of-Concept Study. JMIR Form Res. 2021 Mar 4;5(3):e20175. doi: 10.2196/20175.

Arm/Group Information

ID	Title	Description
FG000	WB-011 / Placebo	3 capsules administered twice daily with morning and evening meal. Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study. Each period lasted two weeks, separated by a washout period of no-less than 3 days. First period - WB-011: WB-011 medical food product. Second period - Placebo: Placebo Capsules identical to those containing WB-011.
FG001	Placebo / WB-011	3 capsules administered twice daily with morning and evening meal. Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study. Each period lasted two weeks, separated by a washout period of no-less than 3 days. First period - Placebo: Placebo Capsules identical to those containing WB-011. Second period - WB-011: WB-011 medical food product.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	WB-011 / Placebo	3 capsules administered twice daily with morning and evening meal. Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study. Each period lasted two weeks, separated by a washout period of no-less than 3 days. First period - WB-011: WB-011 medical food product. Second period - Placebo: Placebo Capsules identical to those containing WB-011.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Technical problems with measurement of temperature data resulting in unreliable data that were uninterpretable. Therefore the endpoint was dropped.

Posted

Through study completion, an average of 5 weeks

ID	Title	Description
OG000	WB-011	3 capsules administered twice daily with morning and evening meal for 2 weeks WB-011: WB-011 medical food product. Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
OG001	Placebo

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	WB-011	3 capsules administered twice daily with morning and evening meal for 2 weeks WB-011: WB-011 medical food product. Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases