What is iLet Beta Bionic Pancreas for Type 1 Diabetes Management?

A review article by

Dr. Somedatta Ghosh (Pal)

One of the hardest aspects of having diabetes is controlling blood sugar levels and taking medicine as needed. But if they have Type-1 Diabetes, the scenario gets significantly worse. They must take insulin while having their blood sugar levels continuously monitored. This article will assist you in comprehending how the cutting-edge iLet Beta Bionic Pancreas is resolving this management issue.

What is Type-1 Diabetes?

It is an autoimmune disease that destroys the insulin-producing pancreatic beta cells. The lack of insulin makes the blood glucose level very high. In most cases, the problem starts during childhood or adolescence. But it can develop in later phases of life too.

The symptoms of Type-1 diabetes (T1DM) vary depending on age, genetic and metabolic characteristics. Thus the treatment needs a personalized approach for each individual. In children, T1DM hampers the brain and cognitive skill development.

It is rare and 5% of total diabetic population suffer from this. But in India number of T1DM patients are increasing and currently almost 8.6 lakh people are suffering from it.

Common Insulin Therapy for Type-1 Diabetes

Patients with T1DM need life-long insulin therapy. The following two types of Insulin need to be administered multiple times in day:

• Basal insulin: It is a slow-acting type of insulin. People take it between mealtimes and before bedtime to control blood sugar outside of eating.
• Prandial insulin: They are rapid and short-acting insulin given at mealtime.

Otherwise, a standard mixture of short-acting and slow-acting insulin can also be used.

Mode of insulin therapy: A variety types of syringes, pens, and pumps are available to administer insulin.  Through syringes and pens, insulin is given as a shot at a time, but insulin pumps provide insulin continuously to the body.

 

Type-1 Diabetic Patient Care Challenges

For T1DM management, consistent self-care is an important requirement and it includes:

• Regular administration of medication and injection
• Self-monitoring of blood glucose
• Eating healthy
• Optimal exercise

Following the above basic steps provides immense benefits to T1DM patients. However, the majority of the patients are teenage school-going kids or adolescent college-going youths. They need to follow a hectic lifestyle and it becomes impossible for them to follow each and every basic step described above.

Hypoglycemia: Adolescents and kids are very prone to irregular dietary habits, typical food preferences, and erratic exercise schedules. With insulin therapy, if patients don’t eat at regular intervals or skip meals, the blood sugar level falls (Hypoglycemia). They start to feel hungry, have trembling hands, excess sweating, and in severe cases they feel confused and can’t focus on a particular thing.

This is a common and potentially dangerous side effect of insulin therapy.

Insulin Availability: In many places in rural India, healthcare infrastructure is not satisfactory.    Patients don’t get the required supply of insulin to control their blood sugar levels. Sometimes professionals are also not available to demonstrate to the patients about the usage of insulin pumps.

 

Required Instruments for Treating T1DM:

Tight control of blood sugar levels is important in managing diabetes. It also helps to reduce diabetes-related complications like eye, nerve, kidney, and cardiovascular disease.

Treatment and management of T1DM are completely dependent on multiple instruments:

• Finger Stick Glucose Monitor: Patients need to check blood glucose levels several times a day.
• Continuous Glucose Monitor: It is a sensor just under your skin measures your glucose levels 24 hours a day.
• Insulin Delivery System: Insulin needs to be administered at regular time interval through injections or a pump without automation.

It is quite easily understandable that managing of T1DM is not easy and nobody can like this pattern of lifestyle. It creates lots of boredom in life and thus a lack of consistency is found in glucose monitoring and insulin administration.

 

iLet Beta Bionic Pancreas: The Most Probable Solution

It is a device invented in in a Boston University biomedical engineering lab. A public benefit corporation Beta Bionics supported the final stages of the development of the device. It is approved by FDA very recently in May 2023.

It is a single device composed of three things:

• Beta Bionics iLet ACE Pump
• iLet Automated Dosing Decision Software
• A compatible FDA-cleared integrated continuous glucose monitor (iCGM)

How does it function?

The users of the iLet just need to enter their weight to get started and the setup process is hugely simplified. The software collects and analyzes blood sugar readings from iCGM and calculates the insulin required, based on the user’s real-time glucose needs. Then the automated ACE pump transfers the required dose of insulin to the body.

It cannot be used for patients below six years of age.

Role of a Patient to Run the Device

A patient has to perform two roles:

• At the very beginning, a patient must insert the correct body weight. Then the machine will start.
• Every time before eating they have to select from the machine that they will be consuming a small, medium, or large amount of carbs.

Advantages

• It requires minimal input from the person using it. It frees a patient from the monotonous role of checking blood sugar and injecting insulin repeatedly.
• It automatically delivers insulin and is calibrated by a person’s body weight. There is no requirement for manual input or adjustments to the insulin doses. Based on the input from an iCGM, iLet Dosing Decision Software independently determines and commands an increase, decrease, maintenance, or suspension of all insulin doses.
• The ‘meal announcement’ feature in iLet replaces the conventional carb counting.
• It is a pocket-sized device and can be attached to the human body easily.

How It Improves Diabetes Management?

• It takes away the constant measuring of blood glucose levels which is a very painful process, and calculations for insulin doses. Thus it brings flexibility and freedom in the lives of T1DM patients. This is the most remarkable contribution of iLet Beta Bionics Pancreas.
• It does not need an expert to start the usage. So patients in rural area, where doctors are not so easily available can use it easily.
• Side by side, clinical trial data proved that it is really effective to keep blood sugar levels in the targeted range.

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References:

1. https://www.fda.gov/news-events/press-announcements/fda-clears-new-insulin-pump-and-algorithm-based-software-support-enhanced-automatic-insulin-delivery
2. https://www.bu.edu/articles/2023/fda-clears-bionic-pancreas-for-type-1-diabetes/
3. https://www.fiercebiotech.com/medtech/beta-bionics-brings-100m-expand-artificial-pancreas-tech-after-fda-nod
4. Castellanos LE, Balliro CA, Sherwood JS, Jafri R, Hillard MA, Greaux E, Selagamsetty R, Zheng H, El-Khatib FH, Damiano ER, Russell SJ. Performance of the Insulin-Only iLet Bionic Pancreas and the Bihormonal iLet Using Dasiglucagon in Adults With Type 1 Diabetes in a Home-Use Setting. Diabetes Care. 2021 Jun;44(6):e118-e120.