NCT04166032

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

Completed Results posted Last updated 9 November 2021

What this trial tests

trial testing Alertgy non-invasive continuous glucose monitoring device (ANICGM) in Type 2 Diabetes in 15 participants. Completed in 30 May 2020.

Timeline

6 November 2019

Primary endpoint
4 February 2020

30 May 2020

Quick facts

Lead sponsor	The Cleveland Clinic
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	15
Start date	6 November 2019
Primary completion	4 February 2020
Estimated completion	30 May 2020
Sites	1 location across United States

Drugs / interventions tested

• Alertgy non-invasive continuous glucose monitoring device (ANICGM)

Conditions studied

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

Sponsor

The Cleveland Clinic

Who can join

Adults 18 to 75, any sex, with Type 2 Diabetes. 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.

Mean Absolute Relative Difference (MARD) of Glucose Values Between the ANICGM and FDA-approved Glucose Monitoring Device Primary · 2 time points taken over 2 separate days respectively, over a span of up to 14 days

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.

Day 2

Group	Value	95% CI
ANICGM	18	12.8 – 42.2

Day 3

Group	Value	95% CI
ANICGM	15	12.3 – 18.4

Sponsor's own description

Diabetes mellitus (DM) affects 30 million people in the United States. To achieve glucose control, most patients are prescribed glucose meters by their physicians. Obtaining glucose levels in this manner necessitates cleaning the fingers, attaching a lancet to a device (or simply using a lancet if a device is not available), pricking the finger with a lancet, placing a drop blood on a strip, and awaiting the readout that results after some chemical reactions. Thereafter, the lancet has to be disposed of in a safe receptacle and the finger has to be blotted to stop the blood from oozing.

The anxiety, pain, and tedious process have led researchers to develop other means of checking glucose levels. There are now continuous glucose monitoring systems (CGMS) that entail inserting a subcutaneous sensor that sends readings through a transmitter. These CGMs may or may not need calibration with a fingerstick glucose reading, and the subcutaneous sensor still has to be changed every 10 -14 days.

The Alertgy non-invasive continuous glucose monitor (ANICGM) is a device that does not entail any subcutaneous insertion of a sensor. It is strapped on to the wrist, and glucose readings are given based on subcutaneous signals. In 2001, a non-invasive device called Glucowatch Biographer was introduced that also involved subcutaneous signals without needing a subcutaneous insertion. However, for various reasons such as long calibration period and reading inaccuracies, the product did not take off. The ANICGM is a promising device that might overcome the limitations of existing and previous methods of non-invasive glucose measurement.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.