Dr Aidin Rawshani

Diabetes technology that improves risk factors, care and quality of life

Contents

Technical devices for diabetes management and control

Several hundred million people suffer from diabetes worldwide. Approximately 5-10% of all people with diabetes have type 1 diabetes. Despite intensive research, type 1 diabetes is still a chronic disease. However, technological progress has had a major impact on the management of type 1 diabetes. Over the past three decades, diabetes management has increasingly benefited from technological innovations aimed at improving diabetes care. In the current era, we are witnessing the development of innovative technologies for diabetes on an unprecedented scale. Technological innovations aim to reduce the risk of future complications and improve the quality of life of people with type 1 diabetes. In the future, people with type 2 diabetes will probably benefit from similar technology.

Technological innovations for diabetes have traditionally been divided into two main categories: insulin administered by pen or pump, and blood glucose monitoring with continuous glucose meters (CGM). More recently, technological developments in diabetes have expanded to include hybrid devices that both monitor glucose and deliver insulin, hybrid devices that handle insulin delivery and glucose monitoring automatically, artificial pancreas, and software that acts as a medical device product. When used appropriately, technology can improve several factors for people with diabetes, but the complexity and rapid change in technology can also be an obstacle to the patient.

A good example of technological innovations for diabetes is continuous blood glucose meters (CGM). CGM is a technology that has improved the lives of millions of people with diabetes. A continuous blood glucose meter (CGM) records sugar levels in your body at regular intervals, and you don’t have to stick your finger. Other modern treatment methods include insulin pumps together with the latest systems (software) that combine insulin pump and CGM devices for algorithm-driven automation of insulin delivery. This means that the insulin pump adapts the insulin doses based on the sugar levels recorded by the CGM device at the very moment the insulin is to be injected. The most developed systems also include the hormone glucagon, in addition to insulin, to increase blood sugar levels if, after all, the patient develops low blood sugar (hypoglycemia). This method of treatment is called artificial pancreas and is so far used for academic purposes.

Basically all individuals who do not have a severely controlled type 1 diabetes should be offered treatment with continuous glucose meters (CGM) so you don’t have to stab your finger daily. Continuous blood glucose meters are typically connected to smartphones (such as Iphone, Samsung, Oneplus, Huawei, Google pixel), which means that the device saves all your blood glucose values. You can then review your blood sugar values and create graphs that illustrate your sugar values over different periods of time. This makes it possible to more easily identify situations or conditions that affect your sugar levels negatively.

Devices that deliver insulin

Most individuals with type 1 diabetes receive insulin either by injection with needle or by continuous subcutaneous insulin infusion, also called insulin pump therapy. Shortly after the well-known research study DCCT (Diabetes Control and Complications Trial) was published in 1993 in the United States, insulin treatment changed in type 1 diabetes, treatment switched to more intensive treatment based on frequent monitoring of blood sugar and multiple daily injections of insulin. Intensive insulin therapy means a person usually has a long-acting basal insulin, usually once or twice a day, and a fast-acting insulin given at a meal (called a meal insulin).

Inhalable insulin

Subcutaneous insulin injections remain the primary method of administration of insulin despite the fact that they are somewhat cumbersome and uncomfortable. Inhaled insulin means you inhale insulin just like asthmatics inhale their asthma medicine. Inhaled insulin had been an attractive alternative to replace “meal insulin”. Despite its conceptual promise, efforts to realize the use of inhaled insulin have not yet succeeded. The development of molecules that can be delivered and absorbed into the lungs (alveoli) has been a challenge. Some studies show that lung capacity may be impaired when using inhaled insulin.

One medicine authorized for use is Exubera (inhalable human insulin) which is part of the pharmaceutical benefit and can be offered to patients with diabetes who have difficulty achieving good blood sugar control due to difficulties with insulin injection. Inhalable insulin, however, is not widely used but represents an important step forward in the treatment of diabetes. It is the first form of insulin that is not delivered by syringes, since the discovery of insulin.

Insulin pens (smart pens and mobile applications)

Insulin pens contain insulin in a cartridge and contain a small, interchangeable needle. This method of treatment was introduced in 1981 because it was practical and easy to implement. Today, there are insulin pens with memory functions that save previous doses of insulin. Some insulin pens are so developed that they save the last 800 insulin injections (insulin dose and opportunity).

Examples of insulin pens that save given insulin doses

  • Humapen memoir
  • Novopen echo
  • Timesulin and gocap (common sensing)

In recent years, pens with built-in bluetooth connection have received approval in Sweden for use in diabetes. These “smart” insulin pens allow you to track doses and automatically transfer data via bluetooth to diabetic apps. It is also possible to share data with healthcare professionals. It is important to know the insulin doses that a person is taking, if you know the insulin doses and can link it to how blood sugar levels react at that moment, you can more easily ‘tailor’ insulin therapy. To date, however, there are no studies showing that “smart” insulin pens are superior to conventional insulin pens.

Smart pens and mobile apps

People with diabetes using smartphone apps or messaging services feel more confident in their ability to manage their condition, are more likely to engage in self-care and have a better quality of life.

Diabetes care apps available on smartphones, smart watches, tablets and computers can be divided into two main types: applications where users can save their data and review afterwards, and messaging services where apps text a specified number (usually your own phone) and can work as prompts or reminders. A review of 22 international studies showed that smartphones could help self-management in diabetes, but also found great variation in the results.

Insulin pen technology has evolved considerably, insulin pens now offer wire locks connection to smartphone applications or to the cloud to record insulin dose and the time the insulin was given, blouse doses are taken into account and data can be shared across multiple platforms.

Smart insulin pen
Smart insulin pen

Although the technology seems to have a positive effect on diabetes control, as reported in all studies, it would be useful to see more detailed information about which apps and messaging services are most useful and effective.

Several smartphone applications now support self-management of diabetes and offer saving of blood glucose data, food intake (including photo recognition), saving information on exercise habits, data transfer and patient training.

Insulin pump

Good control of blood sugar levels is crucial to avoid diabetic complications. In type 1 diabetes and in special cases with type 2 diabetes, intensive insulin therapy is required, which involves several daily injections. The most common complication of this method of treatment is low blood sugar (hypoglycemia), which can have serious consequences. An alternative to multiple daily injections with a needle or pen is a method called continuous administration of insulin by an insulin pump, also known as continuous subcutaneous insulin infusion (CSII).

Treatment with insulin pump has been available for more than 40 years. Most insulin pumps require hoses from the pump to the infusion site, but an alternative (a patch pump) has become available where insulin is delivered directly from a pod attached to the skin, using an integrated or very short infusion set.

The technology behind insulin pumps has improved over the years, modern insulin pumps are usually supplied with additional functions, such as the calculation of bolus and meal doses of insulin. Several models of insulin pumps can calculate how much insulin is needed after food intake to counteract the increase in sugar in the blood from the food you just ate. Some pumps can even calculate the bolus dose needed after physical activity, emotional or stressful situations. Using these advanced features can improve long-term blood sugar (HbA1c). During the meal, the dose of insulin given by the insulin pump is selected. Such a target dose is called “bolus”. Modern insulin pumps use pre-programmed algorithms to select bolus doses either by calculations based on how much carbohydrates the patient eats, or what has previously been an appropriate dose of insulin for that meal. Future insulin pumps will apply artificial intelligence and machine learning methods to predict (predict) your future blood glucose values and adjust the dose to make it perfect for you.

The increasing use of insulin pump therapy over the last 20 years has resulted in improved and increased reliability of insulin pump technology. Various studies show that approximately 40 -60% of all individuals with type 1 diabetes in Western countries have an insulin pump.

Insulin pump with CGM (continuous glucose monitoring)
Insulin pump with CGM (continuous glucose monitoring)

Brief information about insulin pumps

Treatment with insulin pump has been shown to reduce the risk of cardiovascular disease (42%) and premature death (27%) compared to conventional therapy. However, several researchers suggest that there are too few clinical trials that studied the efficacy of the insulin pump compared to conventional treatment. However, observing population studies show a clear risk reduction in complications for those using an insulin pump. However, treatment with insulin pump results in a significant reduction in long-term blood sugar (HbA1c) of approximately 5 mmol/mol on average. In very young children, dosing can be difficult because very small doses of insulin are sometimes enough and therefore insulin pump can be a better alternative. Insulin pumps are very accurate in the dose of insulin given.

Insulin pump therapy requires repeated measurements of sugar (glucose) in the blood, most often the insulin pump is connected to a device that continuously monitors glucose levels in the blood, a so-called CGM unit. Modern pumps have an automatic insulin suspension which means that pre-programmed insulin doses are given as base insulin and meal insulin, while other hybrid pumps only supply insulin in case of low blood sugar falls.

However, not all insulin pumps are compatible with CGM systems and only a few have pre-programmed integrated systems, known as sensor augmented pumps (SAP) in English.

Insulin pumps are widely used today for the treatment of diabetes, especially in the treatment of children and adolescents. In Sweden, it is estimated that treatment with insulin pump therapy costs approximately SEK 11,000 more per patient per year compared to conventional treatment with multiple daily injections. If insulin pump therapy is combined with continuous glucose monitoring, the annual additional cost increases by approximately SEK 28,000 per patient. According to Swedish statistics, about 10 00 patients are treated today with insulin pumps.

Diabetes is a disease that requires great commitment and effort from the patient in a completely different way than most other chronic diseases. It is for this reason that, in many cases, parameters other than medical effects are taken into account. The methods used to administer insulin and control blood glucose have a major impact on the well-being of individual patients and their families. Many people choose insulin pump therapy because they experience increased quality of life. Treatment with insulin pump has several advantages but also requires a part of the patient, managing insulin pump in everyday life is significantly more difficult than dealing with conventional insulin therapy.

Indications for use

Patients should try a multidose regimen with an insulin pen or needle before starting pump therapy. Adult people who wish to pump treatment need to be well acquainted with the measurement of ketones in the body and blood sugar. Insulin pump therapy may be indicated in people with type 1 diabetes who have long-term blood sugar (HbA1c) ≥ 70 mmol/mol or those who have not achieved an individual HbA1C target, despite optimized self-control. Other indications for treatment include, for example, dawn phenomena, which include swinging blood sugar overnight, individuals requiring small insulin doses, and individuals with repeated blood sugar falls (hypoglycaemia).

Insulin pumps supply short-acting or fast-acting insulin in the subcutaneous tissue (subcutaneous fat) at pre-programmed speed, normally half an hour to an hour (speed is adjustable).

Complications of insulin pumps

Studies show that people using an insulin pump need less insulin during the day than anyone who injects insulin yourself with a pen several times a day. However, insulin pump does not contribute to a lower risk of the dreaded complication of diabetes ketoacidosis compared to conventional treatment. With regard to acute blood glucose cases (hypoglycaemia), people with an insulin pump have been observed at a lower risk of hypoglycaemic episodes, especially if they are younger subjects who had several episodes of blood sugar fall in the past.

Closed loop insulin pump systems

Some insulin pumps have an automated suspension of insulin delivery at low blood sugar. These types of insulin pumps are more complex and can most often handle both hypoglycaemia and hyperglycaemia.

The first insulin pump with threshold based insulin suspension was the Medtronic paradigm introduced in 2009. A revised version was approved in 2013. Threshold based insulin pumps interrupt insulin delivery when glucose levels reach a predefined threshold. Several multicenter studies have shown that automated insulin suspension is safe and reduces the frequency of nocturnal hypoglycaemia compared to conventional insulin pump therapy.

Closed-cycle insulin pumps (also known as artificial pancreas or automated insulin pumps) are more elaborate and use algorithms to automatically and continuously modulate insulin delivery based on recorded blood glucose values from CGM units. Several of these pumps also use the hormone glucagon to raise sugar levels in the blood if needed. Common insulin pumps only use insulin, but some automated insulin pumps also use the hormone glucagon, which increases blood sugar. These types of automated insulin pumps are mainly used for academic purposes. Studies show that automated insulin pump therapy leads to an increase in time in the normal range of glucose compared to conventional therapy.

What is the difference between a conventional insulin pump and a closed loop insulin pump?

A self-dosing insulin pump (closed-loop system) means that a CGM unit is connected to an insulin pump that has several pre-programmed functions to provide adapted doses of insulin. When the blood glucose level changes, it is detected by the continuous glucose meter (CGM); the CGM unit sends information to the insulin pump, which adjusts the insulin dose, and the blood glucose level decreases again in response to the insulin. The CGM unit then sends information to the insulin pump that the sugar levels have been normalized. When this happens, the system will automatically shut down.

Regular insulin pumps do not use connected CGM devices and the person must decide how much insulin should be given instead of automatic. One problem with self-dosing insulin pumps is that the glucose level in the tissue fluid (interstitial fluid) recorded by the CGM unit does not change as fast as the blood sugar level, in addition, it takes some time for insulin to be injected into subcutaneous fat and for the effect to take effect.

Artificial pancreas

Closed-cycle insulin pumps (also known as artificial pancreas or automated insulin pumps) are more elaborate and use algorithms to automatically and continuously modulate insulin delivery based on recorded blood glucose values from CGM units. Several of these pumps also use the hormone glucagon to raise sugar levels in the blood if needed. Common insulin pumps only use insulin, but some automated insulin pumps also use the hormone glucagon, which increases blood sugar. These types of automated insulin pumps are mainly used for academic purposes. Studies show that automated insulin pump therapy leads to an increase in time in the normal range of glucose compared to conventional therapy.

Insulin pumps that deliver both glucagon and insulin to raise or decrease blood sugar levels are called bihormonal insulin pump (second generation artificial pancreas) because they mimic the function of the pancreas. These types of insulin pumps deliver glucagon when blood sugar levels are less than predefined thresholds or before sugar levels drop so much.

Several minor studies published to date have confirmed a decrease in risk for hypoglycemia when using artificial pancreas with glucagon. However, at present there are no long-term data to assess the safety and tolerability of continuous supply of glucagon.

Artificial Intelligence and Machine Learning in Diabetes

Artificial intelligence (AI) and machine learning are increasingly being applied to the treatment of diabetes and several other chronic diseases. New medical devices include AI technology that analyzes the relationship between glucose levels, food intake, insulin doses and other factors and provides treatment suggestions based on this data.

Machine learning uses pattern recognition and computing power from AI to enable computers to construct algorithms that learn and make predictions from data, especially in situations like diabetes. Based on data inputs that are becoming increasingly automated, a unique and individualized model is used to make predictions and decisions. Programmed alarm systems for hypo- and hyperglycaemia in a CGM system inform the carrier when the glucose values deviate above or below a desired glucose interval and that corrective action may be justified.

As software and other complex machine learning algorithms are developed for insulin pumps, it improves the quality of life and people can train easier, enjoy more meals and be more spontaneous in everyday life.

Blood glucose measurement

Self-monitoring of blood sugar (blood glucose)

The majority of people with diabetes in the world rely on intermittent self-monitoring of blood glucose (SMBG), which means sticking your finger several times a day with glucose test strips and lancet to measure sugar levels (glucose) in your capillaries. This should be done several times daily to optimize blood sugar levels, usually six to ten times a day, but the actual number should be individualized. A disadvantage of this method is that the blood is controlled sporadically and most often gives snapshots of the sugar levels in the blood, although they are performed frequently.

At the present time, there are more advanced methods for measuring sugar levels in the body. The technical development of blood sugar measurement has been going on for a long time, during the 1980s, the sugar levels in the body were controlled by measuring glucose in the urine. Now we use more advanced measurement methods that continuously measure glucose levels (CGM) without a stick in the finger.

The development of continuous glucose meters (CGM) has been an important step in glucose control in people with diabetes. Currently CGM devices (eng. continous glucose meters) measure the concentration of the fluid between your skin cells (interstitial fluid), because the sugar levels in this liquid reflect the sugar levels in the blood. The apparatus measures the sugar concentration between 1-5 minutes intervals, using fluorescence technology and electrodes carrying different enzymes at the tips. The apparatus may be detached or connected to a computer, mobile phone and insulin pump. A huge advantage of CGM is that the sugar values can simply be collected for retrpective removal and analysis because the values are saved. At the same time, users have the ability to scan sugar levels when they wish by activating the device, this is called flash glucose monitoring and was introduced in 2014, when the user scans the sensor by holding a reader or smartphone near the sensor.

Continuous blood glucose meter (CGM)

What is continuous glucose monitoring?

Continuous glucose monitoring (CGM) automatically tracks blood sugar levels, also called blood sugar, throughout the day and night. You can see your sugar levels at any time by activating the appliance with one click. You can also examine how your sugar levels change over days to see trends. Seeing glucose levels in real time can help you make more informed decisions during the day about how to balance your food, physical activity and medicines.

Since the introduction, the blood glucose meters have become smaller and more accurate: the time taken to measure the glucose concentration has been reduced to a few seconds and the size of the blood sample has been reduced to fractions of one microlitre.

How does a continuous glucose meter (CGM) work?

A CGM works through a small sensor (electrode) inserted under the skin, usually on the stomach or arm. The introduction of the sensor passes quickly and is not painful. The sensor is held in place with adhesive tape. The sensor measures your interstitial glucose level, which is the glucose contained in the fluid between the cells. The sensor records glucose levels at regular intervals and then transmits the information wirelessly via internet connection to a monitor transmitter.

The monitor can be part of an insulin pump or a separate device, which you can carry in a pocket or purse. Some CGM devices send information directly to a smartphone or tablet. Several models are available with different add-on features and benefits.

What are the advantages of using a continuous glucose monitoring device (CGM)?

The main advantage of CGM devices is that they provide information about what’s happening to your blood sugar levels in the last few minutes. The newest devices display glucose readings on a screen so you can see in real time if glucose levels are rising or falling. Some systems also contain an alarm that lets you know when your glucose reaches high or low levels. Some devices may display graphs that reveal glucose levels collected over a certain number of hours or days on the screen. The data collected on all devices can be uploaded to a computer to investigate graphs and other important trend analysis.

  • CGM units lead to better management of your glucose levels
  • Lower risk of hypo- or hyperglycaemia

Specific features of a CGM

CGM is always on and records glucose levels whether you are showering, working, exercising or sleeping. Many CGM have special features that work with information from your glucose readings:

Modern CGM devices have real-time alarms that alert the individual when the device detects predefined thresholds for hypoglycemia and hyperglycemia, as well as rapid fluctuations in blood sugar. You can also record your meals, physical activity and medicines in a CGM unit, along with your glucose levels. When you later check your sugar history, it is easier to determine what affects sugar levels. You can download data (information about your glucose levels) to a computer, tablet or smartphone to more easily see your glucose trends.Some models can send information directly to another person’s smartphone, maybe a parent, partner or caregiver. For example, if a child’s glucose drops dangerously low overnight, CGM can be set to wake a parent in the next room.

Currently, a few CGM models are available that are approved for treatment decisions. This means that you can make changes to your diabetes care plan based solely on CGM results. With other models, you must first confirm a CGM reading with a fingerstick blood sugar test before taking insulin or treating hypoglycemia.

Specific requirements needed to use a CGM

Twice a day, you may need to check the CGM apparatus yourself. You’re testing a drop of blood on a regular glucose meter. The glucose readings directly from the blood should correspond to the sugar levels recorded by your CGM apparatus. You also need to replace the CGM sensor every three to seven days, depending on the model.

Who can use a CGM?

Most people who use CGM have type 1 diabetes. Research is underway to learn how CGM can help people with type 2 diabetes.

CGM is approved for use by adults and children. Some models can be used for children as young as 2 years. Your doctor should recommend a CGM if you or your child comply with one of the following options:

Intensive insulin therapy, also called tight blood sugar control Unconscious hypoglycaemia often have high or low blood sugar levelsYour doctor may suggest that you use a CGM system at all times or just for a few days to help adjust your diabetes care plan.

Most CGM appliances have a short lifetime and only work for just over 6-14 days, after which new equipment must be purchased. Now there are two glucose sensors that are operated under the skin and last up to 6 months (Eversense, senseonics inc). Introducing glucose sensors requires a minor surgical intervention while short-term CGM systems can be applied by the user. CGM can be offered both to individuals who inject multiple times daily with an insulin pen as well as those using an insulin pump.

What are the disadvantages of continuous glucose monitoring (CGM)?

Researchers are working to make CGM more accurate and easier to use. With most CGM models, you can not yet rely on CGM alone to make treatment decisions. For example, before changing the insulin dose, you must confirm a CGM reading by doing a glucose test with a fingerstick.

Keep in mind that the sensors need to be replaced every other day, and the monitors have a lifespan ranging from 6 months to about 2 years, depending on the manufacturer.The need for traditional blood glucose measurement with fingerstick is not gone. This is still needed to calibrate the device and to confirm hypo- or hyperglycaemia before corrective action is taken.

Some CGM units have a “delay time” of between 5 and 20 minutes reported by the various CGM apparatus because the blood glucose reading is taken from interstitial fluid and does not reflect the actual concentration of blood sugar contained in standard fingerstick blood samples. Thus, some CGM units show a discreet difference from standard samples.

Data management of blood glucose values

In parallel with the development of smart insulin pens, continuous glucose meters and insulin pumps, advances have been made in mobile health applications, social platforms and digital tools that help people with diabetes.

Downloading blood sugar data

By downloading data from devices such as insulin pumps and CGM devices to computers and in particular the cloud, the user can review summary statistics and visualize patterns in glucose levels. The information stored in digital aids is used to help healthcare professionals optimize treatment regimens for people with type 1 diabetes and to help users understand their individual patterns and support self-management of diabetes. Individuals with diabetes who routinely download and review their trends in blood sugar also experience improved long-term blood sugar (HbA1c).

Healthcare professionals can, with the patient’s consent, download information about blood glucose levels to investigate the factors that affect blood sugar. Healthcare professionals and the patient can examine tables, diagrams, repeating patterns and trends of blood sugar.

Many digital platforms allow users to link their personal accounts to the healthcare provider’s professional accounts for sharing and viewing data, enabling more frequent dose adjustments and faster clinical interventions than if patients and their caregivers rely on physical nursing meetings.

Several CGM devices can send data directly to the cloud, such as the Dexcom G5 mobile app, the Librelink app, and Minimed connect. If these features are enabled, a third party, such as a parent, partner or healthcare provider, can review users’ CGM data and receive notifications or other warnings on their own smartphone if blood sugar levels rise or fall too low. The benefits of remote monitoring in daily life, in addition to increased convenience, have not yet been formally evaluated in a clinical drug study.

Diabetes applications

The use of mobile health apps, including diabetes apps, is becoming increasingly popular. There are thousands of general health-related apps and over 1,100 diabetes-specific apps. Diabetes apps can improve the self-management of diabetes, as they offer a wide range of functions and activities ranging from training logs and carbohydrate counting.

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