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

NCT ID: NCT04424888

Last Updated: 2022-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-15
• Study Completion Date: 2018-06-29

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.

Conditions

Diabetes Type 2; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

WB-011

3 capsules administered twice daily with morning and evening meal for 2 weeks

Group Type: EXPERIMENTAL

WB-011

Intervention Type: OTHER

WB-011 medical food product.

Continuous Glucose Monitor

Intervention Type: DEVICE

Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.

Placebo

3 capsules administered twice daily with morning and evening meal for 2 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo Capsules identical to those containing WB-011.

Continuous Glucose Monitor

Intervention Type: DEVICE

Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.

Interventions

WB-011

WB-011 medical food product.

Intervention Type: OTHER

Placebo

Placebo Capsules identical to those containing WB-011.

Intervention Type: OTHER

Continuous Glucose Monitor

Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pendulum Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chief Technical Officer, PhD

Role: PRINCIPAL_INVESTIGATOR

Pendulum Therapeutics

Locations

Pendulum Therapeutics Inc

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33661120 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

WB01-205

Identifier Type: -

Identifier Source: org_study_id