SugarBeat is hoping to change the CGM game with a device that uses a stick-on patch, not an under-the-skin sensor. The adhesive patch, about the size of a coin, sticks to skin and reports glucose levels (the company is tight-lipped on how, exactly, the device collects glucose data through the skin) every five minutes for 24 hours. A new patch is applied daily. A connected, rechargeable Bluetooth transmitter sends readings to a receiver or smartphone app. The device must be calibrated once daily with a finger stick. A European launch is planned for this year. The company plans to submit the device for FDA approval later this year.
Insulin in a pill? For years it seemed like a pipe dream, but at the end of 2017, Israeli company Oramed was gearing up for its phase 3 U.S. trial to deliver insulin via a pill. The concept was tricky: Stomach acids destroy the protein before it reaches the blood. But Oramed’s pill is absorbable from the intestine and is thought to act primarily on the liver, which regulates the insulin’s release. Under the conditions studied in the drug’s phase 2B trials, users saw effective blood glucose management without hypoglycemia. Once the phase 3 trial is complete, the company can submit the drug for FDA approval.
New and Improved
Further streamlining its tubeless, waterproof pump system, Insulet is developing the Omnipod Dash. The new system will see an update to the personal diabetes manager (PDM), the handheld device that connects with the pod to set basal and bolus rates. The current PDM is made by Insulet, but the Omnipod Dash’s PDM will be an Android smartphone—locked so it retains only pump functions, not apps or the ability to make calls—that will control insulin delivery and communicate via Bluetooth with the Contour Next blood glucose meter. Bluetooth is a big update for the Omnipod Dash system and will, Insulet hopes, open the door for cloud storage and communication between the pod and other devices, including continuous glucose monitors, in-the-works user and caregiver apps, and the ultimate goal: users’ personal smartphones. Because the Omnipod Dash is an improvement on an already existing device, Insulet isn’t required to conduct additional clinical trials before submitting to the FDA. The Omnipod Dash system should be available in limited U.S. markets this year, pending FDA approval this spring, with full availability three to six months after that. Insulet hopes to have a program allowing the pod to communicate with Dexcom CGMs in 2020.
Wearable glucose monitors will be made available to tens of thousands more people with type 1 diabetes from April 2019, NHS England has announced.
Its decision comes after an investigation found patients in some areas of the country were being denied access to the device.
It reduces the need for finger-prick blood tests and helps people with diabetes to manage their condition.
Diabetes charities called the change of policy a huge step forward.
In England, around 300,000 people have type 1 diabetes.
Under the current system, it is up to the individual clinical commissioning groups (CCGs) to decide whether flash glucose monitoring is available to patients in their area, which means the CCG can dictate the criteria for patients who are eligible for the device, and decide whether they offer it at all.
The device will be funded for people with Type 1 diabetes from 1 April 2019, from next year’s funding growth for local health groups which will allow access to flash monitoring throughout the country.
It is estimated that around 3-5% of patients with Type 1 diabetes in England have access to Freestyle Libre but if clinical commissioning groups (CCGs) were following the guidance correctly, this figure could eventually rise to at least 20-25%. Currently, 144 of 195 clinical commissioning groups have signed up, and today’s announcement mean thousands of patients still missing out will now get access.
Nemaura Places SugarBEAT® Manufacturer Order for UK Commercial Launch
LOUGHBOROUGH, England–Nemaura Medical Inc. (NASDAQ: NMRD), a medical technology company developing the wireless sugarBEAT® non-invasive glucose monitoring system for adjunctive use by persons with diabetes, today announced it has placed an initial order with its designated UK-based contract manufacturer for 12,500 sugarBEAT® rechargeable transmitters, which will be supplemented with approximately 100,000 skin-patches per month, also manufactured in the UK, in preparation for the anticipated sugarBEAT® product launch in the coming months.
SugarBEAT® consists of a daily-disposable adhesive skin-patch connected to a rechargeable transmitter, with an app displaying glucose readings at five minute intervals, and is expected to launch initially in the United Kingdom, upon CE Mark approval.
Dr Faz Chowdhury, CEO and chair of Nemaura Medical commented ‘We expect this initial order will support the successful launch of sugarBEAT® in the UK later this year, and also develop the capacities needed for subsequent scale up and launch in other countries which accept the CE Mark.’
Nemaura Medical recently completed a sugarBEAT® European three-stage clinical trial program consisting of 75 patients over 525 patient days in total, and have used this data to support their CE Mark application. A predecessor sugarBEAT® device, based on a wired wrist-watch form factor, received CE Mark approval in 2016.
About Nemaura Medical, Inc.
Nemaura Medical Inc. (NASDAQ: NMRD), is a medical technology company developing sugarBEAT® as a non-invasive, affordable and flexible glucose monitoring system for adjunctive use by persons with diabetes.
SugarBEAT® consists of a daily-disposable adhesive skin-patch connected to a rechargeable transmitter, with an app displaying glucose readings at five minute intervals.
For more information, please visit www.NemauraMedical.com and www.SugarBEAT.com.
Diabetics may soon be able to pass on the traditional finger prick blood test to monitor their glucose levels.
A team from the University of Bath has developed a non-invasive adhesive patch that draws glucose out from fluid between cells across hair follicles that are individually accessed through an array of miniature sensors using a small electric current.
“A non-invasive—that is, needle-less—method to monitor blood sugar has proven a difficult goal to attain,” Richard Guy, a professor from the Department of Pharmacy & Pharmacology, said in a statement. “The closest that has been achieved has required either at least a single-point calibration with a classic ‘finger-stick,’ or the implantation of a pre-calibrated sensor via a single needle insertion. The monitor developed at Bath promises a truly calibration-free approach, an essential contribution in the fight to combat the ever-increasing global incidence of diabetes.”
With the patch, glucose is collected in small reservoirs. Measurements can be taken every 10 to 15 minutes over the course of several hours.
The test is advantageous to other wearable sensors because it can operate on a small area over an individual hair follicle—significantly reducing the inter-skin and intra-skin variability in glucose extraction and increasing the accuracy of the measurements taken so that calibration through a blood sample is not necessary.
“The specific architecture of our array permits calibration-free operation, and it has the further benefit of allowing realization with a variety of materials in combination,” Adelina Ilie, PhD, from the Department of Physics, said in a statement. “We utilized graphene as one of the components as it brings important advantages: specifically, it is strong, conductive, flexible, and potentially low-cost and environmentally friendly.
“In addition, our design can be implemented using high-throughput fabrication techniques like screen printing, which we hope will ultimately support a disposable, widely affordable device.”
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Patients with diabetes currently have the ability to use devices known as continuous glucose monitors (CGMs) to keep constant tabs on their blood sugar levels, but these also require embedding a needle underneath the skin. However, a new non-invasive technology is emerging that will allow anyone to monitor blood sugar levels in real time.
Fitbit has invested $6 million in a glucose-monitoring startup called Sano, in what appears to be part of Fitbit’s larger plans to make its fitness devices more valuable for overall health.
The investment was first reported by CNBC earlier today; The Verge independently confirmed the investment.
Sano, founded in 2011, is a San Francisco-based company that has been working on what it describes as a minimally invasive, continuous glucose monitor that you’d wear on your skin like a patch. The product doesn’t appear to have shipped yet, and it’s unclear whether this would be sold directly to consumers, or whether it will require FDA approval. That depends on what kind of claims the company is making about the technology.
Minimally invasive glucose monitoring — which means not drawing blood or monitoring the interstitial fluid just below the skin — is a trend among some of the world’s biggest tech companies. Alphabet company Verily says it’s working on a miniaturized continuous glucose monitor. Apple is said to be working on some type of needle-less blood sugar tracker — though as The Verge’s Rachel Becker has reported, it’s incredibly difficult to accurately test blood sugar without breaking the skin.
In September of last year, Fitbit said that it was partnering with Dexcom, Inc. to bring a continuous glucose-monitoring display to the Fitbit Ionic smartwatch. Fitbit has also said it’s working on a solution for tracking sleep apnea, though again, that may require more advanced technology than Fitbit’s current slate of products offers.
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