Clinical trial NCT04424888: Evaluating Use of Continuous Glucose Monitors in a Short-term 2x2-Crossover Study
Official title: Evaluating Use of Continuous Glucose Monitors in a Short-term 2x2-Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Type 2
Diabetes Mellitus
Lead sponsor: Pendulum Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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.

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

Primary outcomes:
measure: Temperature as a Source of Unwanted Variation When Using Freestyle Libre Glucose Sensors
timeFrame: Through study completion, an average of 5 weeks
measure: 2-hour Interstitial Glucose Area Under the Curve (AUC)
timeFrame: Change from baseline to 2 weeks
Secondary outcomes:
measure: Change in Body Mass
timeFrame: Change from baseline to 2 weeks
measure: Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration
timeFrame: Change from baseline to 2 weeks
measure: Expected Lifespan of Continuous Glucose Monitoring (CGM) Sensors
timeFrame: Through study completion, an average of 5 weeks
measure: Number of Pictures Per Day
timeFrame: 2 weeks, (First intervention or second intervention)
measure: Time Between CGM-sensor Scans
timeFrame: 2 weeks, (First intervention or second intervention)
measure: CGM-Smartphone Usability Feedback
timeFrame: Through study completion, an average of 5 weeks.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Pendulum Therapeutics Inc
state: California
Study officials:
affiliation: Pendulum Therapeutics
name: Chief Technical Officer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.