Trial Outcomes & Findings for Validation Study for the Alertgy Non-invasive Continuous Glucose Monitor (ANICGM) (NCT NCT04166032)

Last Updated: 2021-11-09

Results Overview

Hypothesis is that ANICGM device will perform similarly as other blood glucose monitoring devices Mean absolute relative difference (MARD) is computed by taking the arithmetic mean of the absolute relative differences between the ANICGM system measures and the reference standard FS BG, which serves as the denominator of the calculation. The MARD is expressed as a percentage, and a lower MARD signifies better concordance between the two measurements.

Recruitment status

COMPLETED

Target enrollment

15 participants

Primary outcome timeframe

2 time points taken over 2 separate days respectively, over a span of up to 14 days

Results posted on

2021-11-09

Participant Flow

Participant milestones

Participant milestones
Measure	ANICGM non-invasive continuous glucose monitoring device Alertgy non-invasive continuous glucose monitoring device (ANICGM): Alertgy non-invasive continuous glucose monitoring device (ANICGM)
Overall Study STARTED	15
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Validation Study for the Alertgy Non-invasive Continuous Glucose Monitor (ANICGM)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ANICGM n=15 Participants non-invasive continuous glucose monitoring device Alertgy non-invasive continuous glucose monitoring device (ANICGM): Alertgy non-invasive continuous glucose monitoring device (ANICGM)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	55.0 years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 time points taken over 2 separate days respectively, over a span of up to 14 days

Outcome measures

Outcome measures
Measure	ANICGM n=15 Participants non-invasive continuous glucose monitoring device Alertgy non-invasive continuous glucose monitoring device (ANICGM): Alertgy non-invasive continuous glucose monitoring device (ANICGM)
Mean Absolute Relative Difference (MARD) of Glucose Values Between the ANICGM and FDA-approved Glucose Monitoring Device Day 2	18 percentage difference Interval 12.8 to 42.2
Mean Absolute Relative Difference (MARD) of Glucose Values Between the ANICGM and FDA-approved Glucose Monitoring Device Day 3	15 percentage difference Interval 12.3 to 18.4

Adverse Events

ANICGM

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

Kimberly Jenkins, Research Administrator

Cleveland Clinic

Phone: 216-445-4791

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Company will review any publication submission within 30 days of estimated due date. If CCF does not hear from company we are to assume we are free to publish. If company identities patentable information they can request for CCF to withhold submission for 90 days.
Publication restrictions are in place

Restriction type: OTHER