NCT04424888

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Pendulum Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	WB-011	WB-011 medical food product.
OTHER	Placebo	Placebo Capsules identical to those containing WB-011.
DEVICE	Continuous Glucose Monitor	Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.

Timeline

• Start date: 2018-03-15
• Primary completion: 2018-04-29
• Completion: 2018-06-29
• First posted: 2020-06-11
• Last updated: 2022-12-08
• Results posted: 2022-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study