NCT04424888

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

Completed NA Results posted Last updated 8 December 2022

What this trial tests

NA trial testing WB-011 in Diabetes Type 2 in 6 participants. Completed in 29 June 2018.

Timeline

15 March 2018

Primary endpoint
29 April 2018

29 June 2018

Quick facts

Lead sponsor	Pendulum Therapeutics
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	6
Start date	15 March 2018
Primary completion	29 April 2018
Estimated completion	29 June 2018
Sites	1 location across United States

Drugs / interventions tested

• WB-011
• Placebo
• Continuous Glucose Monitor

Conditions studied

• Diabetes Type 2 — all drugs for Diabetes Type 2 →
• Diabetes Mellitus — all drugs for Diabetes Mellitus →

Sponsor

Pendulum Therapeutics

Who can join

Adults 18 to 75, any sex, with Diabetes Type 2 or Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

2-hour Interstitial Glucose Area Under the Curve (AUC) Primary · 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.

Group	Value	95% CI
WB-011	118.2167	± 1334.929
Placebo	613.3667	± 604.2183

Change in Body Mass Secondary · Change from baseline to 2 weeks

Weight measured via Scale

Group	Value	95% CI
WB-011	-0.2	± 2.131666
Placebo	-1.72	± 2.138224

Change in Fecal Quantitative PCR Measures of Probiotic Strain Concentration Secondary · 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.

Akkermansia muciniphila

Group	Value	95% CI
WB-011	0.0000143	± 0.0000102
Placebo	-0.00000194	± 0.00000367

Bifidobacterium infantis

Group	Value	95% CI
WB-011	0.0000220	± 0.0000259
Placebo	-0.00000286	± 0.00000639

Clostridium beijerinckii

Group	Value	95% CI
WB-011	0	± 0
Placebo	0	± 0

Clostridium butyricum

Group	Value	95% CI
WB-011	0.0000000313	± 0.00000100
Placebo	-0.00000131	± 0.00000294

Anaerobutyricum hallii

Group	Value	95% CI
WB-011	0.000371	± 0.000585
Placebo	-0.000118	± 0.000230

Expected Lifespan of Continuous Glucose Monitoring (CGM) Sensors Secondary · 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.

Group	Value	95% CI
All Study Participants	3	± 0

Number of Pictures Per Day Secondary · 2 weeks, (First intervention or second intervention)

Average number of pictures per day using the smartphone application per period, used to measure study fatigue.

Group	Value	95% CI
First Intervention	5.85	± 2.72
Second Intervention	5.46	± 2.46

Time Between CGM-sensor Scans Secondary · 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.

Group	Value	95% CI
First Intervention	2.91	± 1.99
Second Intervention	4.53	± 2.17

CGM-Smartphone Usability Feedback Secondary · 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"

Group	Value	95% CI
All Participants	8.25	± 1.258306

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Medical Food Assessment Using a Smartphone App With Continuous Glucose Monitoring Sensors: Proof-of-Concept Study.
   Roux de Bézieux H, Bullard J, Kolterman O, Souza M, et al · · 2021 · cited 3× · PMID 33661120 · DOI 10.2196/20175