Trial Outcomes & Findings for Evaluating Use of Continuous Glucose Monitors in a Short-term 2x2-Crossover Study (NCT NCT04424888)
NCT ID: NCT04424888
Last Updated: 2022-12-08
Results Overview
Temperature impacts the glucose level recorded by the Freestyle Libre glucose sensors. The thermostat of the Freestyle Libre glucose sensors can be assessed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
Through study completion, an average of 5 weeks
Results posted on
2022-12-08
Participant Flow
Recruitment through local biotechnology community network over the time period of 3/15/18-3/16/18.
Participant milestones
| Measure |
WB-011 / Placebo
3 capsules administered twice daily with morning and evening meal. Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
Each period lasted two weeks, separated by a washout period of no-less than 3 days.
First period - WB-011: WB-011 medical food product. Second period - Placebo: Placebo Capsules identical to those containing WB-011.
|
Placebo / WB-011
3 capsules administered twice daily with morning and evening meal. Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
Each period lasted two weeks, separated by a washout period of no-less than 3 days.
First period - Placebo: Placebo Capsules identical to those containing WB-011. Second period - WB-011: WB-011 medical food product.
|
|---|---|---|
|
First Intervention
STARTED
|
3
|
3
|
|
First Intervention
COMPLETED
|
3
|
3
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout
STARTED
|
3
|
3
|
|
Washout
COMPLETED
|
3
|
3
|
|
Washout
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
3
|
3
|
|
Second Intervention
COMPLETED
|
3
|
3
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating Use of Continuous Glucose Monitors in a Short-term 2x2-Crossover Study
Baseline characteristics by cohort
| Measure |
WB-011 / Placebo
n=3 Participants
3 capsules administered twice daily with morning and evening meal. Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
Each period lasted two weeks, separated by a washout period of no-less than 3 days.
First period - WB-011: WB-011 medical food product. Second period - Placebo: Placebo Capsules identical to those containing WB-011.
|
Placebo / WB-011
n=3 Participants
3 capsules administered twice daily with morning and evening meal. Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
Each period lasted two weeks, separated by a washout period of no-less than 3 days.
First period - Placebo: Placebo Capsules identical to those containing WB-011. Second period - WB-011: WB-011 medical food product.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 5 weeksPopulation: Technical problems with measurement of temperature data resulting in unreliable data that were uninterpretable. Therefore the endpoint was dropped.
Temperature impacts the glucose level recorded by the Freestyle Libre glucose sensors. The thermostat of the Freestyle Libre glucose sensors can be assessed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Change from baseline to 2 weeksPopulation: Intent to treat
Change in area under interstitial glucose concentration versus time curve (AUC) during standardized self-administered 2-hour Meal Tolerance Test.
Outcome measures
| Measure |
WB-011
n=6 Participants
3 capsules administered twice daily with morning and evening meal for 2 weeks
WB-011: WB-011 medical food product.
Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
|
Placebo
n=6 Participants
3 capsules administered twice daily with morning and evening meal for 2 weeks
Placebo: Placebo Capsules identical to those containing WB-011.
Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
|
|---|---|---|
|
2-hour Interstitial Glucose Area Under the Curve (AUC)
|
118.2167 min * mg/dL
Standard Deviation 1334.929
|
613.3667 min * mg/dL
Standard Deviation 604.2183
|
SECONDARY outcome
Timeframe: Change from baseline to 2 weeksPopulation: Intent to treat
Weight measured via Scale
Outcome measures
| Measure |
WB-011
n=6 Participants
3 capsules administered twice daily with morning and evening meal for 2 weeks
WB-011: WB-011 medical food product.
Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
|
Placebo
n=5 Participants
3 capsules administered twice daily with morning and evening meal for 2 weeks
Placebo: Placebo Capsules identical to those containing WB-011.
Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
|
|---|---|---|
|
Change in Body Mass
|
-0.2 kilograms
Standard Deviation 2.131666
|
-1.72 kilograms
Standard Deviation 2.138224
|
SECONDARY outcome
Timeframe: Change from baseline to 2 weeksPopulation: Intent to treat; one subject did not provide stool samples.
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.
Outcome measures
| Measure |
WB-011
n=5 Participants
3 capsules administered twice daily with morning and evening meal for 2 weeks
WB-011: WB-011 medical food product.
Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
|
Placebo
n=5 Participants
3 capsules administered twice daily with morning and evening meal for 2 weeks
Placebo: Placebo Capsules identical to those containing WB-011.
Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
|
|---|---|---|
|
Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration
Anaerobutyricum hallii
|
0.000371 ng / ng
Standard Deviation 0.000585
|
-0.000118 ng / ng
Standard Deviation 0.000230
|
|
Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration
Akkermansia muciniphila
|
0.0000143 ng / ng
Standard Deviation 0.0000102
|
-0.00000194 ng / ng
Standard Deviation 0.00000367
|
|
Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration
Bifidobacterium infantis
|
0.0000220 ng / ng
Standard Deviation 0.0000259
|
-0.00000286 ng / ng
Standard Deviation 0.00000639
|
|
Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration
Clostridium beijerinckii
|
0 ng / ng
Standard Deviation 0
|
0 ng / ng
Standard Deviation 0
|
|
Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration
Clostridium butyricum
|
0.0000000313 ng / ng
Standard Deviation 0.00000100
|
-0.00000131 ng / ng
Standard Deviation 0.00000294
|
SECONDARY outcome
Timeframe: Through study completion, an average of 5 weeksPopulation: Intent to treat
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.
Outcome measures
| Measure |
WB-011
n=6 Participants
3 capsules administered twice daily with morning and evening meal for 2 weeks
WB-011: WB-011 medical food product.
Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
|
Placebo
3 capsules administered twice daily with morning and evening meal for 2 weeks
Placebo: Placebo Capsules identical to those containing WB-011.
Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
|
|---|---|---|
|
Expected Lifespan of Continuous Glucose Monitoring (CGM) Sensors
|
3 Number of sensors
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: 2 weeks, (First intervention or second intervention)Population: All participants
Average number of pictures per day using the smartphone application per period, used to measure study fatigue.
Outcome measures
| Measure |
WB-011
n=6 Participants
3 capsules administered twice daily with morning and evening meal for 2 weeks
WB-011: WB-011 medical food product.
Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
|
Placebo
n=6 Participants
3 capsules administered twice daily with morning and evening meal for 2 weeks
Placebo: Placebo Capsules identical to those containing WB-011.
Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
|
|---|---|---|
|
Number of Pictures Per Day
|
5.85 Average number of photos per day
Standard Deviation 2.72
|
5.46 Average number of photos per day
Standard Deviation 2.46
|
SECONDARY outcome
Timeframe: 2 weeks, (First intervention or second intervention)Population: All participants.
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.
Outcome measures
| Measure |
WB-011
n=6 Participants
3 capsules administered twice daily with morning and evening meal for 2 weeks
WB-011: WB-011 medical food product.
Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
|
Placebo
n=6 Participants
3 capsules administered twice daily with morning and evening meal for 2 weeks
Placebo: Placebo Capsules identical to those containing WB-011.
Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
|
|---|---|---|
|
Time Between CGM-sensor Scans
|
2.91 hours
Standard Deviation 1.99
|
4.53 hours
Standard Deviation 2.17
|
SECONDARY outcome
Timeframe: Through study completion, an average of 5 weeks.Population: Two participants did not complete the questionnaire.
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"
Outcome measures
| Measure |
WB-011
n=4 Participants
3 capsules administered twice daily with morning and evening meal for 2 weeks
WB-011: WB-011 medical food product.
Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
|
Placebo
3 capsules administered twice daily with morning and evening meal for 2 weeks
Placebo: Placebo Capsules identical to those containing WB-011.
Continuous Glucose Monitor: Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
|
|---|---|---|
|
CGM-Smartphone Usability Feedback
|
8.25 Units on a scale
Standard Deviation 1.258306
|
—
|
Adverse Events
WB-011
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
James Bullard, PhD, Chief Technical Officer
Pendulum Therapeutics
Phone: (844) 912-2256
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place