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NCT04166032 · ClinicalTrials.gov registry record
Validation Study for the Alertgy Non-invasive Continuous Glucose Monitor (ANICGM)
A clinical trial, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- 15
- Enrollment target
NCT04166032: Completed study, sponsored by The Cleveland Clinic.
NCT04166032 is a clinical trial that has completed, run by The Cleveland Clinic. The registered enrollment target is 15 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04166032 has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- 15 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DEVICE Alertgy non-invasive continuous glucose monitoring device (ANICGM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-11-06 |
| Est. Completion | 2020-05-30 |
What the finished NCT04166032 record still lists
NCT04166032 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Alertgy non-invasive continuous glucose monitoring device (ANICGM) is the first listed.
NCT04166032 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04166032 about?
NCT04166032 is a clinical study titled "Validation Study for the Alertgy Non-invasive Continuous Glucose Monitor (ANICGM)". 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...
What is the current status of trial NCT04166032?
This trial is currently completed. The enrollment target is 15 participants. The study started on 2019-11-06. Estimated completion is 2020-05-30.
What interventions are being tested in trial NCT04166032?
The interventions under investigation include: Alertgy non-invasive continuous glucose monitoring device (ANICGM) (DEVICE).
Who is sponsoring clinical trial NCT04166032?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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