Diabetes Mellitus, Diabetes Type 2
Conditions
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
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.
Interventions
OTHERWB-011
WB-011 medical food product.
OTHERPlacebo
Placebo Capsules identical to those containing WB-011.
DEVICEContinuous Glucose Monitor
Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
Sponsors
Pendulum Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Temperature as a Source of Unwanted Variation When Using Freestyle Libre Glucose Sensors | Through study completion, an average of 5 weeks | Temperature impacts the glucose level recorded by the Freestyle Libre glucose sensors. The thermostat of the Freestyle Libre glucose sensors can be assessed. |
| 2-hour Interstitial Glucose Area Under the Curve (AUC) | Change from baseline to 2 weeks | Change in area under interstitial glucose concentration versus time curve (AUC) during standardized self-administered 2-hour Meal Tolerance Test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expected Lifespan of Continuous Glucose Monitoring (CGM) Sensors | Through study completion, an average of 5 weeks | 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. |
| Number of Pictures Per Day | 2 weeks, (First intervention or second intervention) | Average number of pictures per day using the smartphone application per period, used to measure study fatigue. |
| Change in Body Mass | Change from baseline to 2 weeks | Weight measured via Scale |
| CGM-Smartphone Usability Feedback | Through study completion, an average of 5 weeks. | 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 |
| Time Between CGM-sensor Scans | 2 weeks, (First intervention or second intervention) | 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. |
| Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration | Change from baseline to 2 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment through local biotechnology community network over the time period of 3/15/18-3/16/18.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| 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. | 3 |
| Total | 6 |
Baseline characteristics
| Characteristic | WB-011 / Placebo | Placebo / WB-011 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 2 Participants | 5 Participants |
| Region of Enrollment United States | 3 participants | 3 participants | 6 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
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.
Time frame: Change from baseline to 2 weeks
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WB-011 | 2-hour Interstitial Glucose Area Under the Curve (AUC) | 118.2167 min * mg/dL | Standard Deviation 1334.929 |
| Placebo | 2-hour Interstitial Glucose Area Under the Curve (AUC) | 613.3667 min * mg/dL | Standard Deviation 604.2183 |
p-value: 0.21875Wilcoxon (Mann-Whitney)
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.
Time frame: Through study completion, an average of 5 weeks
Population: Technical problems with measurement of temperature data resulting in unreliable data that were uninterpretable. Therefore the endpoint was dropped.
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
Time frame: Through study completion, an average of 5 weeks.
Population: Two participants did not complete the questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WB-011 | CGM-Smartphone Usability Feedback | 8.25 Units on a scale | Standard Deviation 1.258306 |
Secondary
Change in Body Mass
Weight measured via Scale
Time frame: Change from baseline to 2 weeks
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WB-011 | Change in Body Mass | -0.2 kilograms | Standard Deviation 2.131666 |
| Placebo | Change in Body Mass | -1.72 kilograms | Standard Deviation 2.138224 |
p-value: 0.90625Wilcoxon (Mann-Whitney)
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.
Time frame: Change from baseline to 2 weeks
Population: Intent to treat; one subject did not provide stool samples.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WB-011 | Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration | Bifidobacterium infantis | 0.0000220 ng / ng | Standard Deviation 0.0000259 |
| WB-011 | Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration | Clostridium butyricum | 0.0000000313 ng / ng | Standard Deviation 0.000001 |
| WB-011 | Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration | Clostridium beijerinckii | 0 ng / ng | Standard Deviation 0 |
| WB-011 | Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration | Anaerobutyricum hallii | 0.000371 ng / ng | Standard Deviation 0.000585 |
| WB-011 | Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration | Akkermansia muciniphila | 0.0000143 ng / ng | Standard Deviation 0.0000102 |
| Placebo | Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration | Anaerobutyricum hallii | -0.000118 ng / ng | Standard Deviation 0.00023 |
| Placebo | Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration | Akkermansia muciniphila | -0.00000194 ng / ng | Standard Deviation 0.00000367 |
| Placebo | Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration | Bifidobacterium infantis | -0.00000286 ng / ng | Standard Deviation 0.00000639 |
| Placebo | Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration | Clostridium beijerinckii | 0 ng / ng | Standard Deviation 0 |
| Placebo | Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration | Clostridium butyricum | -0.00000131 ng / ng | Standard Deviation 0.00000294 |
Comparison: Paired t-test for the species Akkermansia Munciphilae.p-value: 0.02t-test, 1 sided
Comparison: Paired t-test for the species Bifidobacterium infantis.p-value: 0.078t-test, 1 sided
Comparison: Paired t-test for the species Clostridium beijerinckii.
Comparison: Paired t-test for the species Clostridium butyricum.p-value: 0.2t-test, 1 sided
Comparison: Paired t-test for the species Anaerobutyricum hallii.p-value: 0.12t-test, 1 sided
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.
Time frame: Through study completion, an average of 5 weeks
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WB-011 | Expected Lifespan of Continuous Glucose Monitoring (CGM) Sensors | 3 Number of sensors | Standard Deviation 0 |
Secondary
Number of Pictures Per Day
Average number of pictures per day using the smartphone application per period, used to measure study fatigue.
Time frame: 2 weeks, (First intervention or second intervention)
Population: All participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WB-011 | Number of Pictures Per Day | 5.85 Average number of photos per day | Standard Deviation 2.72 |
| Placebo | Number of Pictures Per Day | 5.46 Average number of photos per day | Standard Deviation 2.46 |
Comparison: We test whether the average number of daily photos is greater in period 1 than in period 2.p-value: 0.41t-test, 1 sided
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.
Time frame: 2 weeks, (First intervention or second intervention)
Population: All participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WB-011 | Time Between CGM-sensor Scans | 2.91 hours | Standard Deviation 1.99 |
| Placebo | Time Between CGM-sensor Scans | 4.53 hours | Standard Deviation 2.17 |
Comparison: We test whether the average time between consecutive scans is smaller in period 1 than in period 2.p-value: 0.13t-test, 1 sided