Living with the chronic condition of diabetes requires ongoing management to maintain blood sugar (glucose) levels within a healthy range. Simple in theory, but managing the disease is far from easy.

Patients with diabetes need to regularly test their blood sugar levels using a glucose meter. They must also be fastidious about a healthy diet and exercise routine and take prescribed medications like insulin. Lifestyle changes are also recommended—getting enough sleep, managing stress, quitting smoking, and avoiding alcohol in moderation. 

It’s quite a bit to manage. Although a healthcare professional can offer guidance to keeping blood glucose at a healthy level, it’s almost entirely on the patient to adhere to any guidelines.

One useful tool to ease diabetes patients’ burden is a continuous glucose monitor (CGM), a wearable technology that tracks glucose levels over time. It measures the glucose level in the interstitial fluid—the fluid in the spaces around the body’s cells. It comes from substances that leak out of blood capillaries, and one of those substances is glucose.

The sensor in a CGM is placed just under the skin where the fluid is, not in a blood vessel.

There are a handful of CGM devices available that work pretty much the same way. All CGMs have three basic components:

• The sensor—a small piece of material that measures real-time glucose levels in the interstitial fluid. This sensor is inserted under the skin with an applicator. Sensors usually last seven to 15 days, depending on the brand. (There’s also an implantable CGM that lasts for months—a small pellet inserted under the skin of the upper arm.)
• A transmitter to wirelessly send glucose data from the sensor to a device where it can be viewed. Some CGM systems have a reusable transmitter that attaches to each new sensor; others have a transmitter that’s part of the disposable sensor.
• A smartphone app, receiver, or insulin pump that displays real-time glucose levels and displays a graph of the history of the user’s levels. It may also show if the glucose level is trending up or down.

“We’re seeing the impact of over-the-counter continuous glucose monitors,” said Jake Leach, executive VP and chief operating officer of San Diego, Calif.-based CGM maker Dexcom. “Last year we released Stelo, the first over-the-counter glucose biosensor in the U.S. specifically designed to help people with type 2 diabetes not using insulin and those with prediabetes. Stelo is fueling our market force, as more people are leveraging Stelo and CGM technology for general wellness purposes. By leveraging data retrieved from Stelo, users can make real-time adjustments to their diet and exercise to improve health outcomes. The personalized data is invaluable.”

Therapeutic technology for diabetes management comes in the form of an insulin pump. This wearable device supplies a continuous flow of rapid-acting insulin underneath the skin. Most insulin pumps are small, computerized devices that are about the size of a juice box or deck of cards.

An insulin pump mimics how the pancreas naturally releases insulin. It delivers insulin in one of two ways:

• Small, continuous doses called basal insulin. There will likely be multiple basal rates in hour increments throughout the day—this is because the body needs different rates of background insulin throughout a 24-hour timeframe. All pumps can automatically adjust basal doses based on glucose levels from a connected CGM. Pumps also have a manual setting so the pump can deliver basal rates programmed by the user and their healthcare provider.
• Manual surges of insulin when eating and to mitigate high blood sugar, called a bolus. The pump leverages information entered about carbohydrate intake and glucose level to calculate how much bolus insulin is needed. Most pumps recommend a dose, which can then be confirmed or adjusted before insulin is delivered.

“The growing intersection between consumer technology and medical devices drives our industry,” said Jim Hollingshead, director, president, and CEO of Acton, Mass.-based automated insulin delivery (AID) system maker Insulet. “We always look at ways to make automated insulin delivery easier for our customers, which includes providing a sleek, user-friendly interface, operability with various CGM sensors, and smartphone compatibility. We focus on scaling our capabilities, expanding access across the globe, and bringing a cascade of innovations that improve health outcomes and quality of life for our customers—all under an umbrella of delivering a seamless customer experience for users and actionable insights for their healthcare providers.”

In March 2024, Dexcom earned U.S. Food and Drug Administration (FDA) clearance for its Stelo CGM. The glucose biosensor was the first that doesn’t require a prescription and targeted the roughly 25 million people in the U.S. with type 2 diabetes who don’t use insulin but can still benefit from a CGM.

The small biosensor is worn on the back of the upper arm and leverages the company’s most accurate glucose-sensing technology. It was designed to provide personalized glucose insights sent directly to a smartphone, showing how food, exercise, and sleep can impact blood sugar without the use of fingersticks. It became available for purchase in the U.S. in August 2024.

Dexcom launched a proprietary generative AI (GenAI) platform for Stelo in December. It became the company’s first product to use GenAI-enabled tech for weekly insights.

As the foundation to build its proprietary GenAI platform, Dexcom recruited Google Cloud’s Vertex AI platform and Gemini models.

“Building on our longstanding history of biosensing technology, the new GenAI platform will enhance Stelo’s Weekly Insights by analyzing individual health data patterns to reveal insights into lifestyle choices and glucose levels, while also providing actionable insights to help users improve their metabolic health,” said Leach. “As the first CGM manufacturer to integrate GenAI into glucose biosensing technology, the enhanced feature will offer users personalized tips and recommendations related to diet, exercise, and sleep that are contextualized in the Stelo app. This allows Stelo to act as a friendly health ‘coach’ in a user’s pocket—helping them make proactive, informed lifestyle decisions.”

In November 2024, Dexcom began a strategic partnership with ŌURA, maker of the Oura Ring. The Oura Ring is a smart ring that continually collects data on over 20 biometrics that impact the wearer’s wellbeing. Dexcom also invested $75 million in ŌURA’s Series D funding at that time.

The duo plans to launch integrations that allow data to flow between Dexcom and ŌURA products, including biosensors, apps, Oura Ring, and the Oura App. This way, users can track glucose levels and gain an understanding of the impact of behaviors and biology on their metabolic health.

“We decided to join forces to help millions of people improve their metabolic health through the integration of Dexcom glucose data with vital sign, sleep, stress, heart health, and activity data from Oura Ring. The goal of this partnership is to create a differentiated, powerful product experience for those seeking more personalized ways to understand and manage their health more holistically. We anticipate the partnership will attract a larger shared customer base that will help users better understand the link between activity, sleep, nutrition, and their glucose,” explained Leach.

Both companies will co-market and cross-sell each other’s products. The first app integration from this partnership is expected to launch in the first half of this year.

In November 2024, Insulet revealed that its Omnipod 5 AID system became compatible with Abbott’s FreeStyle 2 Plus CGM sensor in the U.S. Omnipod 5 is the first tubeless AID that communicates with a CGM—the company rolled out compatibility with the Dexcom G7 CGM in June 2024.

“We focus on providing customers with options and allowing them to use the sensor of their choice,” said Hollingshead. “We have strong relationships with both of our CGM partners, Abbott and Dexcom, that help us meet customer requirements. With the added compatibility of Abbott’s FreeStyle Libre 2 Plus sensor, Omnipod 5 is now the most connected tubeless AID system in the U.S. This latest innovation will allow millions of people who take insulin the ability to get started on Pod therapy using their preferred CGM sensor.”

In August 2024, Insulet earned FDA clearance that extended Omnipod 5’s use to adults with type 2 diabetes. This FDA nod made Omnipod 5 the only AID system cleared for both type 1 and type 2 diabetes management.

Only a quarter of individuals with type 2 diabetes on insulin are achieving an HbA1c of 7.0% or less, and half of this population has an HbA1c greater than 8.0%.¹ Despite guideline recommendations for insulin treatment in advanced disease, insulin therapy is often delayed or not appropriately intensified.²

The company’s SECURE T2D clinical study showed that compared to previous insulin therapy methods in adults with type 2 diabetes, using Omnipod 5 resulted in considerable reductions in HbA1c: 0.8% overall and 2.1% in those with prior HbA1c 9.0% or higher. Time in hyperglycemia and total daily insulin dose were also reduced, and there was a 20% improvement in time in range, increasing by 4.8 hours per day, without increasing time in hypoglycemia.

“The FDA clearance of Omnipod 5, the only AID system cleared for both type 1 and type 2 diabetes, makes it commercially available to adults living with insulin-requiring type 2 diabetes,” explained Hollingshead. “This allows these individuals to achieve better health outcomes while living with greater confidence and freedom through the benefits of tubeless Pod therapy. With demonstrated and significant outcomes, including more time in range, lower A1c, and less diabetes distress, Omnipod 5 is setting a new standard in diabetes management. We’re thrilled with the opportunity to make a lasting impact on the insulin-requiring type 2 diabetes community.”

Omnipod 5 rolled out in Italy, Denmark, Finland, Norway, and Sweden in January 2025.

Abbott Laboratories also released an over-the-counter CGM option in September 2024 to expand access to the technology. The Lingo CGM is comprised of a biosensor and mobile app and is based on the company’s FreeStyle CGM technology. It’s available for adults who aren’t on insulin, tracks glucose in real-time, and offers personal insights and coaching.

The Lingo biosensor is worn on the back of the arm for up to two weeks and continuously streams glucose data to the Lingo app on a smartphone. A graph of glucose reactions updates in real-time based on continuous readings from the biosensor. The body’s glucose spikes are translated into one, easy-to-understand metric.

Meals and exercise can be logged in the app. Lingo can also be synced with the Apple Health app to automatically log workouts. Tailored recommendations are based on foods logged, time of day, and accrued Lingo Count (glucose spike function). “Lingo Challenges” also help create new habits by earning badges and completing challenges.

The same week, Abbott revealed that it was working with Beta Bionics to integrate Abbott’s FreeStyle Libre 3 Plus sensor with the iLet Bionic Pancreas automated insulin delivery system. Beta Bionics’ iLet Bionic Pancreas is an autonomous insulin delivery system that streamlines diabetes management and reduces the burden on patients and physicians.

iLet reduces the need for carb counting or calculating insulin corrections throughout the day, as the device determines 100% of the insulin doses. The only input required to get started on the iLet is the user’s weight. iLet was the first AID integration of FreeStyle Libre 3 Plus available in the United States. The integration launched in Q4 2024, offering people a new way to manage their type 1 diabetes that will fit seamlessly into their lives.

“By working with various industry partners, we’re giving users more choices in the technology they use to manage their diabetes effectively,” Jared Watkin, Abbott’s executive VP of diabetes, told the press. “Our collaboration with Beta Bionics will offer an automated closed-loop system that is accurate, easy to use, and can help users focus less on diabetes and more on life.”

In October, Abbott earned FDA clearance to remove the imaging contraindication for its FreeStyle Libre 2 and 3 CGM sensors. Imaging procedures are usually part of diabetes care. This includes X-rays to spot bone injuries, CT scans to identify kidney stones and blood clots, and MRIs for detailed images of organs and tissues to detect issues like brain injury, ischemic heart disease, and fatty liver disease.

The CGMs can now be worn during common imaging procedures, making Abbott’s systems the first, only patient-applied CGM sensors approved for these screenings.

In November, Medtronic gained an FDA nod for its new InPen app, which features missed meal dose detection. This paves the way for the launch of the company’s Smart MDI system with the Simplera CGM, which received FDA approval in August 2024. Medtronic’s Smart MDI system merges its InPen smart insulin pen with its newest Simplera CGM. Simplera is the company’s first disposable, all-in-one CGM and is half the size of its previous CGMs.

Medtronic said this clearance makes its system the first in the market to recommend corrections for missed or inaccurate insulin doses. This offers real-time, personalized insights for people on multiple daily injection (MDI) therapy. The company said its Smart MDI system minimizes the guesswork involved in diabetes management. It helps address a significant unmet need for MDI users who juggle various decisions related to insulin dosing on a daily basis.

Medtronic said it will begin a limited market launch starting with existing standalone CGM and InPen customers, followed by abroader commercial rollout.

“This is a significant leap forward for those on multiple daily injections, offering intelligent dosing insights and simplifying diabetes management,” Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP, told the press. “By reducing the guesswork out of insulin dosing, this tool helps maintain stable blood sugars, optimize long-term health, and reduce complications from hyperglycemia.”

More Than the Sum of Its Parts

Technological innovations in CGM sensors and insulin pumps have created challenges for medical device companies and their suppliers to keep coming up with new and improved solutions. One challenge is constantly making products smaller, which can require a product’s many components to have the ability to carry out several tasks simultaneously.

“Innovations in sensor technology, connectivity, and integration with CGM systems are reshaping the insulin pump landscape,” said said Kristian Larsson, sales director at Nolato MediTech AB, a Hörby, Sweden-based company that specializes in developing and producing polymer-based products. “The integration of insulin pumps with CGMs ensures more accurate and dynamic insulin dosing, reducing the risks of hypoglycemia and hyperglycemia. Insulin pumps are also increasingly leveraging AI algorithms to predict glucose levels and adjust insulin delivery automatically, paving the way for advanced closed-loop systems, often referred to as artificial pancreas systems.”

Nolato GW is a section of the company based in Bethel, Vt., that has experience in producing complex, high-precision components and assemblies for devices like insulin pumps. The company works with advanced, medical-grade polymers and silicone with the goal of advancing device performance—particularly in areas like durability, biocompatibility, and patient comfort.

“The aging population and prevalence of lifestyle-related diseases such as obesity contribute to the growing need for effective diabetes management tools,” said Larsson. “There is a growing demand for user-friendly, wearable medical devices that enhance the quality of life for patients, emphasizing convenience and precision. Manufacturers are focusing on creating smaller, lightweight, and discreet devices that offer greater comfort and usability for patients in their daily lives.”

Plymouth, Minn.-based ProMed Molded Products is a provider of contract manufacturing services and specializes in silicone and plastics molding. Some of the products the company manufactures support long-term implantable components like those used for diabetes management. 

The company serves the diabetes technology market through infusion ports and pumps, balloons, shunts, catheters and valves, and implantable glucose monitor and sensing devices.

“A huge market force is the expanded interest in use of CGM sensors from type I diabetes patients to type 2 and the general population interested in improving their health and wellness,” said James Arps, director of business developmed at ProMed Pharma. “The recent FDA approval of two over-the-counter products could dramatically expand the base of users.”

Implantable biosensors for continuous glucose monitoring can substantially improve diabetes management. However, their barrier to use includes gradual functionality loss after implantation because of foreign body response.

Sensor miniaturization, paired with drug-eluting, biocompatible coatings, is a potential strategy to boost CGM performance in vivo. 

“Steroid-eluting sensors can reduce the production of inflammatory cytokines that occur when the sensor is implanted subcutaneously or punctures the skin,” said Arps. “The inflammatory response can degrade the sensing chemistries and reduce sensor life. Prolonging sensor life with steroid-eluting components means fewer replacement procedures or needlesticks.”

References

¹ bit.ly/mpodiabetes03251
² bit.ly/mpodiabetes03252