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

P

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

6 participants in 2 patient groups, including a placebo group

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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