- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04424888
Evaluating Use of Continuous Glucose Monitors in a Short-term 2x2-Crossover Study
November 10, 2022 updated by: Pendulum Therapeutics
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94107
- Pendulum Therapeutics Inc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WB-011
3 capsules administered twice daily with morning and evening meal for 2 weeks
|
WB-011 medical food product.
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
|
Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
Placebo Capsules identical to those containing WB-011.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Temperature as a Source of Unwanted Variation When Using Freestyle Libre Glucose Sensors
Time Frame: Through study completion, an average of 5 weeks
|
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)
Time Frame: Change from baseline to 2 weeks
|
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
Time Frame: Change from baseline to 2 weeks
|
Weight measured via Scale
|
Change from baseline to 2 weeks
|
Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration
Time Frame: Change from baseline to 2 weeks
|
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
Time Frame: Through study completion, an average of 5 weeks
|
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
Time Frame: 2 weeks, (First intervention or second intervention)
|
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
Time Frame: 2 weeks, (First intervention or second intervention)
|
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
Time Frame: Through study completion, an average of 5 weeks.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chief Technical Officer, PhD, Pendulum Therapeutics
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2018
Primary Completion (Actual)
April 29, 2018
Study Completion (Actual)
June 29, 2018
Study Registration Dates
First Submitted
May 27, 2020
First Submitted That Met QC Criteria
June 9, 2020
First Posted (Actual)
June 11, 2020
Study Record Updates
Last Update Posted (Estimate)
December 8, 2022
Last Update Submitted That Met QC Criteria
November 10, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WB01-205
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
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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