Type 2 DiabetesNCT04166032
Validation Study for the Alertgy Non-invasive Continuous Glucose Monitor (ANICGM)
A study testing Alertgy non-invasive continuous glucose monitoring device (ANICGM) in people with Type 2 Diabetes, run by The Cleveland Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Alertgy non-invasive continuous glucose monitoring device (ANICGM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2019to 30 May 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes on diet or on pharmacologic treatment for diabetes
- Hemoglobin A1c between 7.5 - 10.0%
- Age 18 - 75 years old
Who cannot join
- Patients taking prandial insulin
- Fasting blood glucose by fingerstick of < 70 mg/dL or >250 mg/dL
- Pregnancy
- End stage renal disease
- Decompensated or acute heart failure
- Medications that may cause false readings with glucose meters: acetaminophen, ascorbic acid, dopamine, maltodextrin, mannitol
- Conditions that limit the ANICGM such as lesions on the forearms
- Other conditions that the investigator deems will affect the conduct of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation Study for the Alertgy Non-invasive Continuous Glucose Monitor
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.
Read the detailed description
The ANICGM uses a weak electromagnetic field generated by its wrist band sensor to look into the body to produce a spectrum that provides a measurement of blood glucose present in the wrist area of the body. The core sensing technology used is dielectric spectroscopy, and has been shown capable of measuring blood glucose, non-invasively, in a laboratory environment. The system uses proprietary and patented dielectric materials and signal processing to enhance performance in both selectivity and sensitivity for blood glucose measurement.
Much like how a MRI uses a strong magnetic field and its interaction with the body to create a picture of what is inside, the ANICGM uses a safe weak low frequency radiofrequency field to take a picture of a person's chemical spectrum, some of it specific only to blood glucose.
The device sends and receives back signals from the wrist area that are used to generate a dielectric spectrum once every 6 seconds. The POC BG using the Accuchek Inform II will be used to provide calibration values for the ANICGM every 5 minutes in mg/dL, during the calibration process. The POC BG levels will be entered into the Alertgy laptop and a proprietary calibration program will be used to analyze the spectral data collected and will generate a calibration algorithm.
- Conditions
- Type 2 Diabetes
- Being tested
- Alertgy non-invasive continuous glucose monitoring device (ANICGM)
- Keywords
- glucose monitor
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alertgy non-invasive continuous glucose monitoring device (ANICGM)Device
Alertgy non-invasive continuous glucose monitoring device (ANICGM)
| Study group | Role | What they receive |
|---|---|---|
| ANICGM | Experimental | non-invasive continuous glucose monitoring device Receives: Device: Alertgy non-invasive continuous glucose monitoring device (ANICGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Absolute Relative Difference (MARD) of Glucose Values Between the ANICGM and FDA-approved Glucose Monitoring Device
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.
Measured: 2 time points taken over 2 separate days respectively, over a span of up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start6 Nov 2019
- Primary completion4 Feb 2020
- Study completion30 May 2020
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.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Alertgy
- Responsible party
- Principal investigator, M. Cecilia Lansang, MD, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166032
- Sponsor's protocol ID
- 18-1385
- Status last verified
- Oct 2021
- First submitted
- 13 Nov 2019
- Last updated
- 9 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study for the Alertgy Non-invasive Continuous Glucose Monitor
- ClinicalTrials.gov ID
- NCT04166032
- Acronym / sponsor ID
- 18-1385
- Conditions
- Type 2 Diabetes
- Keywords
- glucose monitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Alertgy
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 4 Feb 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 18 Nov 2019 (actual)
- Results
- Posted 9 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The ANICGM uses a weak electromagnetic field generated by its wrist band sensor to look into the body to produce a spectrum that provides a measurement of blood glucose present in the wrist area of the body. The core sensing technology used is dielectric spectroscopy, and has been shown capable of measuring blood glucose, non-invasively, in a laboratory environment. The system uses proprietary and patented dielectric materials and signal processing to enhance performance in both selectivity and sensitivity for blood glucose measurement.
Much like how a MRI uses a strong magnetic field and its interaction with the body to create a picture of what is inside, the ANICGM uses a safe weak low frequency radiofrequency field to take a picture of a person's chemical spectrum, some of it specific only to blood glucose.
The device sends and receives back signals from the wrist area that are used to generate a dielectric spectrum once every 6 seconds. The POC BG using the Accuchek Inform II will be used to provide calibration values for the ANICGM every 5 minutes in mg/dL, during the calibration process. The POC BG levels will be entered into the Alertgy laptop and a proprietary calibration program will be used to analyze the spectral data collected and will generate a calibration algorithm.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ANICGM | Experimental | Device: Alertgy non-invasive continuous glucose monitoring device (ANICGM)non-invasive continuous glucose monitoring device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes on diet or on pharmacologic treatment for diabetes
- Hemoglobin A1c between 7.5 - 10.0%
- Age 18 - 75 years old
Key exclusion criteria (8 listed)
- Patients taking prandial insulin
- Fasting blood glucose by fingerstick of < 70 mg/dL or >250 mg/dL
- Pregnancy
- End stage renal disease
- Decompensated or acute heart failure
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 |
|---|---|---|
| Alertgy non-invasive continuous glucose monitoring device (ANICGM)Alertgy non-invasive continuous glucose monitoring device (ANICGM) | Device | ANICGM |
Primary outcome
Mean Absolute Relative Difference (MARD) of Glucose Values Between the ANICGM and FDA-approved Glucose Monitoring Device
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alertgy non-invasive continuous glucose monitoring device (ANICGM) in people with Type 2 Diabetes, run by The Cleveland Clinic 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 3 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 9 Nov 2021. 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. 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 9 Nov 2021). 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?
Mean Absolute Relative Difference (MARD) of Glucose Values Between the ANICGM and FDA-approved Glucose Monitoring Device (time frame: 2 time points taken over 2 separate days respectively, over a span of up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2021.