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

Pendulum Therapeutics

Status

Completed

Conditions

Diabetes Mellitus

Diabetes Type 2

Treatments

Other: WB-011

Other: Placebo

Device: Continuous Glucose Monitor

Study type

Interventional

Funder types

Industry

Identifiers

NCT04424888

WB01-205

Details and patient eligibility

About

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

Full 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.

Enrollment

6 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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