Diabetes Type 2NCT04424888
Evaluating Use of Continuous Glucose Monitors in a Short-term 2x2-Crossover Study
A study testing WB-011 and Continuous Glucose Monitor in people with Diabetes Type 2 and Diabetes Mellitus, run by Pendulum Therapeutics at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Type 2, Diabetes Mellitus
- What is being tested?
- WB-011 and Continuous Glucose Monitor
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2018to 29 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pendulum Therapeutics Inc
San Francisco, California, 94107
About this study
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
Read the 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
- Being tested
- WB-011, Placebo, Continuous Glucose Monitor
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WB-011Other
WB-011 medical food product.
PlaceboOther
Placebo Capsules identical to those containing WB-011.
Continuous Glucose MonitorDevice
Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| WB-011 | Experimental | 3 capsules administered twice daily with morning and evening meal for 2 weeks Receives: Other: WB-011; Device: Continuous Glucose Monitor |
| Placebo | Placebo comparator | 3 capsules administered twice daily with morning and evening meal for 2 weeks Receives: Other: Placebo; Device: Continuous Glucose Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline to 2 weeks
Secondary outcomes (6)
Change in Body Mass
Weight measured via Scale
Measured: Change from baseline to 2 weeks
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.
Measured: Change from baseline to 2 weeks
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.
Measured: Through study completion, an average of 5 weeks
Number of Pictures Per Day
Average number of pictures per day using the smartphone application per period, used to measure study fatigue.
Measured: 2 weeks, (First intervention or second intervention)
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.
Measured: 2 weeks, (First intervention or second intervention)
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"
Measured: Through study completion, an average of 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start15 Mar 2018
- Primary completion29 Apr 2018
- Study completion29 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pendulum Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Technical Officer, PhD, Principal investigator, Pendulum Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424888
- Sponsor's protocol ID
- WB01-205
- Status last verified
- Nov 2022
- First submitted
- 27 May 2020
- Last updated
- 8 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 33661120
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Use of Continuous Glucose Monitors in a Short-term 2x2-Crossover Study
- ClinicalTrials.gov ID
- NCT04424888
- Acronym / sponsor ID
- WB01-205
- Conditions
- Diabetes Type 2, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Pendulum TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 29 Apr 2018 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Posted 8 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WB-011 | Experimental | Other: WB-011, Device: Continuous Glucose Monitor3 capsules administered twice daily with morning and evening meal for 2 weeks |
| Placebo | Placebo comparator | Other: Placebo, Device: Continuous Glucose Monitor3 capsules administered twice daily with morning and evening meal for 2 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WB-011WB-011 medical food product. | Other | WB-011 |
| PlaceboPlacebo Capsules identical to those containing WB-011. | Other | Placebo |
| Continuous Glucose MonitorAbbott Freestyle Libre(™) Glucose Sensors were used throughout the study. | Device | Placebo, WB-011 |
Primary outcome
Temperature as a Source of Unwanted Variation When Using Freestyle Libre Glucose Sensors
Time frame: 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)
Time frame: 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.
6 secondary outcomes
Change in Body Mass
Time frame: Change from baseline to 2 weeks
Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration
Time frame: Change from baseline to 2 weeks
Expected Lifespan of Continuous Glucose Monitoring (CGM) Sensors
Time frame: Through study completion, an average of 5 weeks
Number of Pictures Per Day
Time frame: 2 weeks, (First intervention or second intervention)
Time Between CGM-sensor Scans
Time frame: 2 weeks, (First intervention or second intervention)
CGM-Smartphone Usability Feedback
Time frame: Through study completion, an average of 5 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33661120Roux 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Technical Officer, PhD principal investigator
Pendulum Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WB-011 and Continuous Glucose Monitor in people with Diabetes Type 2 and Diabetes Mellitus, run by Pendulum Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature as a Source of Unwanted Variation When Using Freestyle Libre Glucose Sensors (time frame: Through study completion, an average of 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04424888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.