Notebookcheck Logo

Wrist-worn non-invasive continuous glucose monitor from Movano takes step closer to FDA clearance after type 1 diabetes pilot study completion

Movano has produced a rendering of its non-invasive continuous glucose monitor wearable. (Image source: Movano - edited)
Movano has produced a rendering of its non-invasive continuous glucose monitor wearable. (Image source: Movano - edited)
A non-invasive continuous glucose monitor wearable from Movano Inc. has taken an important step on its development path by finishing a second approved pilot study. Testing involved people with type 1 diabetes comparing results from finger-stick methods and existing CGMs with those produced by the Movano prototype wearable.

Movano is known for its smart-ring wearables, which we reported on at the end of 2021. However, the company has also been busy with its smartwatch-like device that is targeting diabetics looking for an alternative to painful finger-sticking that can leave scar tissue and lead to sensitivity loss. Movano has been working on this non-invasive continuous glucose monitor (CGM) for some time, with initial reports emerging in the middle of 2020 about such a blood sugar monitor in the shape of a smartwatch.

However, while there are numerous biotech and healthtech firms seemingly chasing this dream of producing an FDA-approved painless non-invasive glucose monitor for the mass market, some disappear without a trace for years. But a recent press release from Movano has reignited interest in this particular wearable and is evidence that this device still holds promise for millions of people having to cope with daily diabetes management.

The press release reveals that a second IRB-approved study has been completed, with 10 participants comparing data produced by finger-sticking and pre-existing CGMs with a prototype Movano wrist-worn wearable. Such blood glucose level measurement comparisons will allow Movano to make the fine adjustments required to eventually get the wearable approved by the FDA.

Glucose levels are taken using Movano’s radio frequency-enabled integrated circuits, meaning there is no skin puncture or blood sample required. The wearable provides continuous data and can also track other biomarkers, such as SpO2 levels, heart rate, and blood pressure. Movano’s CEO, Dr. John Mastrototaro, hopes the end product will be both “stylish and affordable”.

Buy Dexcom G6 adhesive patches on Amazon

Rendering of the Movano wearable. (Image source: Movano)
Rendering of the Movano wearable. (Image source: Movano)

Source(s)

Movano Completes its Second Glucose Pilot Study
The Company used its wrist-worn wearable device prototype to capture glucose and other vital health data on individuals with type 1 diabetes

(PRNewsfoto/Movano)
NEWS PROVIDED BY

Movano
Feb 17, 2022, 09:00 ET

SHARE THIS ARTICLE
     
PLEASANTON, Calif., Feb. 17, 2022 /PRNewswire/ -- Movano Inc. (NASDAQ:MOVE), a health technology company designing devices that inspire and empower you to live a healthier, happier life, today announced the completion of an Institutional Review Board (IRB)-approved glucose pilot study, which was conducted on 10 participants with type 1 diabetes of varying gender, age, ethnicity and weight in conjunction with an independent FDA-compliant clinical lab.

During each four hour session, participants wore Movano's wrist-worn wearable prototype, which uses the Company's proprietary Radio Frequency-enabled ICs and allows Movano to calculate  glucose, blood pressure,  heart rate, and respiration rate estimates. The study will compare the Movano data to results captured with an FDA cleared finger stick glucose tester, a subject's existing CGM device, and/or a vital sign monitoring device. The study will ultimately allow Movano to further refine the algorithms it uses to calculate glucose values and vital sign measurements and will also help guide the Company as to what specific follow-on studies will be done in support of future FDA clearances.

"The goal for our technology is to create devices that are stylish and affordable for you to wear every day and are also cleared by the FDA to help you better monitor and manage the effects of chronic conditions, like diabetes and hypertension," said Dr. John Mastrototaro, CEO of Movano Inc. "To do so, we have an aggressive roadmap to test our radio frequency-enabled technology and pursue accuracy studies to eventually gain FDA clearances for heart rate, SpO2, respiratory rate as well as non-invasive glucose and cuffless blood pressure monitoring. The glucose pilot we just completed is extremely valuable as it allows us to gather the data needed to improve the accuracy of our algorithms and hone in on our future clinical study plans."

For more information on Movano, please visit movano.com.

About Movano
Founded in 2018, Movano Inc. is a health-focused technology company creating simple, smart and personalized devices designed to inspire and empower individuals on their health journey live a happier, healthier life. Movano's technology is being developed to provide vital health information, including glucose and blood pressure data, in a variety of form factors to meet individual style needs and give users actionable feedback in order to improve the quality of their life. For more information, visit movano.com.

Forward Looking Statements
This press release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results; product development, clinical trial and regulatory initiatives; our strategies, positioning and expectations for future events or performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in our registration statement on Form S-1, as amended, and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission, including under the caption "Risk Factors."  Any forward-looking statement in this release speaks only as of the date of this release. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

SOURCE Movano


Read all 5 comments / answer
static version load dynamic
Loading Comments
Comment on this article
Please share our article, every link counts!
> Notebook / Laptop Reviews and News > News > News Archive > Newsarchive 2022 02 > Wrist-worn non-invasive continuous glucose monitor from Movano takes step closer to FDA clearance after type 1 diabetes pilot study completion
Daniel R Deakin, 2022-02-24 (Update: 2022-02-24)