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

NCT04424888 | Completed Results FDA Device

• 1 other identifier: WB01-205
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Type 2; Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Temperature as a Source of Unwanted Variation When Using Freestyle Libre Glucose Sensors

  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)

  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 Outcomes (6)

• Change in Body Mass

  Change from baseline to 2 weeks

• Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration

  Change from baseline to 2 weeks

• Expected Lifespan of Continuous Glucose Monitoring (CGM) Sensors

  Through study completion, an average of 5 weeks

• Number of Pictures Per Day

  2 weeks, (First intervention or second intervention)

• Time Between CGM-sensor Scans

  2 weeks, (First intervention or second intervention)

Study Arms (2)

WB-011

EXPERIMENTAL

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

Other: WB-011; Device: Continuous Glucose Monitor

Placebo

PLACEBO COMPARATOR

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

Other: Placebo; Device: Continuous Glucose Monitor

Interventions

WB-011 OTHER

WB-011 medical food product.

WB-011

Placebo OTHER

Placebo Capsules identical to those containing WB-011.

Placebo

Continuous Glucose Monitor DEVICE

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

Placebo; WB-011

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pendulum Therapeutics: lead

Study Sites (1)

Pendulum Therapeutics Inc

San Francisco, California, 94107, United States

Location

Related Publications (1)

• 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.

  PMID: 33661120 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: James Bullard, PhD, Chief Technical Officer
• Organization: Pendulum Therapeutics

james.bullard@pendulum.co

(844) 912-2256

Study Officials

• Chief Technical Officer, PhD

  Pendulum Therapeutics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 11, 2020
• Study Start: March 15, 2018
• Primary Completion: April 29, 2018
• Study Completion: June 29, 2018
• Last Updated: December 8, 2022
• Results First Posted: December 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)