The World Health Organization (WHO) describes diabetes as a chronic, metabolic disease characterised by elevated levels of blood glucose (or blood sugar), which, over time, can lead to serious damage to the heart, blood vessels, eyes, kidneys and nerves. It also states that about 422 million people worldwide have diabetes, with majority living in low-and middle-income countries, and that 1.5 million deaths directly are attributed to diabetes each year.

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Type 1 diabetes is an autoimmune disorder in which the pancreas is unable to produce enough insulin, whereas in Type 2 diabetes, the body develops insulin resistance, leading to abnormally high blood sugar levels. As such, many diabetes patients‘ lives depend on insulin treatment that can be administered through injections or pumps to keep their blood glucose levels under control.

But, a new technology — Automated Insulin Delivery — is looking to mimic the role of the pancreas, heralding the way for game-changing methods to manage diabetes and its many manifestations. Also called Artificial Pancreas (AP) or closed-loop systems, the technology combines diabetes devices, namely an insulin pump connected to a continuous glucose monitor (CGM), and a smartphone program. While insulin pumps have been in use since the 1980s to mimic the secretion from a healthy pancreas for patients with type 1 diabetes, “these need to be carried out manually multiple times daily and hence did not meet expectations”, said Dr Jothydev Kesavadev, diabetologist and MD of Jothydev’s Diabetes Research Centres, Trivandrum.

But, artificial pancreas automatically monitors the blood glucose level, calculates the amount of insulin needed at different points during the day, and delivers it. This system helps control blood glucose levels making it easier for people to keep it in range.

What is AP and how does it work?

“Three parts make up AP – glucose sensor, program, and pump. Continuous glucose monitor (CGM) tracks blood glucose levels every few minutes using a tiny sensor placed under the skin that wirelessly sends the information to a program. The sensor sends the necessary information to the smartphone or an insulin infusion pump. Based on the reading, the insulin pump then delivers small doses of insulin throughout the day when blood glucose is above target range,” described Dr David Chandy, consultant and section Co-ordinator, endocrinology, Sir HN Reliance Foundation Hospital.

“One will be able to know how much insulin he/she needs, and the insulin infusion pump gets a signal when insulin needs to be delivered. Then, the insulin infusion pump delivers the insulin one needs. However, the levels vary depending on the expert guidance,” said Dr Pritam Moon, consultant physician and Diabetologist, Wockhardt Hospital Mira Road.

The predictive suspend system calculates the blood glucose level and will stop delivering insulin before your blood glucose level gets too low. “Stopping insulin delivery at the right moment can help a person with type 1 diabetes avoid low blood sugar, or hypoglycemia, a condition when a person’s blood glucose level is lower than their target range,” said Dr Chandy.

However, the lacuna was automating the delivery of insulin — which “always used to be a dream”, said Dr Kesavadev. “For more than 75 years, surgical methods were tried but all those clinical trials failed. The automation started with the availability of continuous glucose sensing and algorithms to control insulin delivery. Though ‘Artificial Pancreas’ have been available for 10 years, the success in automation was only up to 40-60 per cent,” said Dr Kesavadev.

Why are we talking about diabetes treatments?

Time in range is an important development in diabetes care (Source: Dr Jothydev Kesavadev)

The cost of treating diabetes is similar to treating heart attacks, kidney disease, strokes, neuropathy, blindness, amputations, mental disease etc., all of which can be prevented with “proper management of the primary disease”. “This is why such expensive devices are given free of cost in many countries since they will prove highly cost effective in the long run,” said Dr Kesavadev who co-authored a paper — Digital Health and Diabetes: Where are we now? — published in the Therapeutic Advances in Endocrinology and Metabolism journal in October 2021.

In the paper, Dr Kesavadev, Gopika Krishnan and Viswanathan Mohan — mention how the diabetes community has been adopting various technologies such as connected glucose meters, continuous glucose monitoring systems, continuous subcutaneous insulin infusion, closed-loop systems, digitalisation of health data, and diabetes-related apps for the prevention and management of the condition.

WHO also states that for people living with diabetes, access to affordable treatment, including insulin, is critical to their survival. “There is a globally agreed target to halt the rise in diabetes and obesity by 2025,” reads WHO’s website.

In an earlier interview with indianexpress.com, Luke Coutinho, Holistic Lifestyle Coach – Integrative and Lifestyle Medicine and Founder of YouCare – All about YOU, said how the “integration of technology in diabetes management” is an excellent step towards changing the face of this epidemic in our country and the world.

“One thing that we are constantly being reminded of through our day-to-day practice is the fact that each of us are bio individuals, in not just genes, but also the way our body responds to a particular food or ingredient. This is where technologies like CGMS (continuous glucose monitoring system) can help us personalise and tailor our approach towards a particular individual,” he explained.

What are different types of AP?

There are several types of artificial pancreas systems, said Dr Chandy.

They include

Threshold suspend and predictive suspend systems

The threshold suspend and predictive suspend systems can temporarily stop or “suspend” delivering insulin if blood glucose goes low.

Threshold suspend system

What is AP’s 780G?

780G If the meal-related insulin dosage is inadequate, it will also deliver an automated correction dose. (Source: Dr Jothydev Kesavadev)

780G is an advanced type of insulin pump that automatically monitors the level of insulin to be administered depending on one’s dietary intake.

“This is the first time with 780G, that the success in automation is reaching 80 per cent and many patients using it having a success with time in range (glucose within normal range) of more than 90 per cent in 24 hours,” Dr Kesavadev told indianexpress.com.

According to Dr Kesavadev, 780G is an international product from the United States. “Similar technologies have not reached India yet. It’s life-saving especially for type 1 diabetes children who battle day and night to keep glucose in range,” he asserted.

How does 780G work?

Dr Kesavadev who along with Dr Arun Shankar, Gopika Krishnan and Geethu Sanal deployed and trained 780G in a 26-year-old person with type 1 diabetes at Jothydev’s Diabetes Hospital and Research Centre, Trivandrum, said that 780G automatically increases the dose of insulin when the glucose is rising, and automatically reduces the dose of insulin when glucose is trending low. “This happens once in every five minutes without any intervention from the user. If the meal-related insulin dosage is inadequate, it will also deliver an automated correction dose. The results are amazing. In our first patient, the glucose is remaining within normal range consistently for more than 90 per cent of the time. This is an incredible achievement,” he said in a press statement.

The user on their part said, “For several reasons, I haven’t slept peacefully for the last 16 years ever since my diagnosis of diabetes. The new automated insulin delivery device is giving me peaceful sleep and has completely transformed my life for good”.

Factors to consider before starting

*Age — Some models are approved for children as young as two years old, while others are approved for people ages six years and older

*Whether you can place the devices in the correct position without help, check that they are working properly, and adjust them or enter carbohydrate data as needed

*Parents should talk about appropriate artificial pancreas systems with the child’s doctor.

*How much an artificial pancreas will cost

Limitations

Dr Chandy contends that AP systems are not completely “hands off.” “You have to regularly maintain the devices to be sure they are working properly and enter meal sizes into the system every time you eat,” he said.

You will also need to

*check the CGM and infusion pump catheter to be sure they are in place and change them when needed

*check the CGM for accuracy

Considering these factors, does it still hold promise?

Notably, diabetes burden has increased worldwide with India having the second-largest numbers in the world after China with 77 million people with diabetes, as per Indian Council of Medical Research—India Diabetes (ICMR—INDIAB) study.

AP has a great potential to ease the burden of diabetes patients in India, however the main challenge is the cost, asserted Dr Chandy. “The most advanced system that is available in India would cost around six lakhs and the recurring monthly expenses would be around 12 to 15 thousand. Hopefully, health insurance and reimbursement permitting, the majority of people with type 1 diabetes could be using an artificial pancreas in next five years,” he said.

Though very expensive, 780G is the only commercially available life saving device in India, stressed Dr Kesavadev. “For more patients to benefit with this therapy, the government needs to give these to them free of cost especially for the age group between seven and 24 years with diabetes,” he opined while sharing that he and his team are also “creating an AP which should be much more cost effective for the common man”.

Dr Kesavadev also pointed out that more doctors and nurses need to be trained to use this “sophisticated technology”, in the absence of which insulin pump therapy usually fails. “The training will also help them in identifying eligible candidates and the type and degree of training to be given to the users and caretakers at home”.

There can be errors and inaccuracies, and everyone may not understand how to use them, pointed out Dr Moon. “It will take time for people in India to get acquainted with this technology. India has a fast-growing diabetes population and many new methods have been adopted to help but adaptation takes time,” said Dr Moon.

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