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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04424888
• Other study ID #: WB01-205
• Status: Completed
• Phase: N/A
• Start date: March 15, 2018
• Est. completion date: June 29, 2018

Study information

• Verified date: November 2022
• Source: Pendulum Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 29, 2018
• Est. primary completion date: April 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

Other:
• WB-011
WB-011 medical food product.
• Placebo
Placebo Capsules identical to those containing WB-011.

Device:
• Continuous Glucose Monitor
Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.

Locations

Country	Name	City	State
United States	Pendulum Therapeutics Inc	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Pendulum Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in Body Mass	Weight measured via Scale	Change from baseline to 2 weeks
Secondary	Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration	Fecal quantitative PCR of product strain will be measured throughout the study if subject provide stool samples. Mass Fraction is measured and the delta between the start and end of each period is computed.	Change from baseline to 2 weeks
Secondary	Expected Lifespan of Continuous Glucose Monitoring (CGM) Sensors	To measure the lifespan of CGM sensors, we recorded how many sensors were worn per participant during the study. Sensors were replaced either at the end of the recommended 10-day period, or when they were accidentally removed.	Through study completion, an average of 5 weeks
Secondary	Number of Pictures Per Day	Average number of pictures per day using the smartphone application per period, used to measure study fatigue.	2 weeks, (First intervention or second intervention)
Secondary	Time Between CGM-sensor Scans	Average number of hours between CGM-sensor scans using the smartphone application during the study period. The subjects were instructed to scan at least every eight hours because the CGM-sensor does not save the data after eight hours without scanning.	2 weeks, (First intervention or second intervention)
Secondary	CGM-Smartphone Usability Feedback	Questionnaire to assess usability of the CGM-sensor using the smartphone application.; Question was: "Would you recommend others to a study like this? On a scale of 1-10 with 1 being no and 10 being absolutely"	Through study completion, an average of 5 weeks.