Artificial Pancreas for Young Children with type I diabetes Approved by FDA

September 13, 2020

1136

No more finger pricks. No severe low blood sugar events. No second guessing blood-glucose levels.

The FDA has authorized and approved an algorithm that enables the 2^nd artificial pancreas insulin-delivery system, specifically for children from two to six years-of-age that have type 1 diabetes - a life-threatening, chronic condition.

mother and daughter having fun in a park

The MiniMed 770G system made by Medtronic is a hybrid, closed-loop, diabetes management device that automatically monitors blood-glucose levels every five minutes. While it will provide the appropriate basal insulin dosage, parents and caregivers need to manually request insulin doses to counter carbohydrate consumption at mealtime.

Parents will be able to monitor their child’s blood-glucose level remotely in real-time using a Smartphone application, which will inevitably lessen anxiety - especially when parents are apart from their children.

“Children between two and six years-of-age have unique challenges in managing type 1 diabetes,” states Laura M. Nally, MD, FAAP, Pediatric Endocrinologist and Instructor of Pediatrics at Yale School of Medicine in New Haven, Connecticut.

“They often have unpredictable eating habits and spontaneous activity, and they may not be able to recognize and communicate symptoms of hypoglycemia and hyperglycemia to parents and caregivers,” Nally added.

There are potential risks and cost disadvantages, i.e. skin infections at the catheter site, increase of diabetic ketoacidosis from pump malfunction and absorption issues. The MiniMed 770G system is expensive and requires appropriate training from a healthcare professional.

As per FDA’s approval agreement, Medtronic will conduct a post-market study to evaluate the performance of the MiniMed 770G device in real-world settings.

“As a parent, I understand very personally why connectivity is so important, and I’m pleased we’ll be able to broaden access to hybrid closed-loop therapy with the additional peace of mind caregivers need to ensure the well-being of their loved ones. This latest launch underscores my personal commitment to making life easier for people living with diabetes through the technologies we deliver,” said Sean Salmon, Executive Vice President and President of the Diabetes Group at Medtronic.

The Medtronic MiniMed 770G system is not yet available in Canada.

Complications from type 1 diabetes

The Mayo Clinic states that complications from Type 1 Diabetes in children can include:

Heart and blood vessel disease: Diabetes increases a child’s risk of developing conditions such as narrowed blood vessels, high blood pressure, heart disease and stroke later in life.

Nerve damage: Excess sugar can injure the walls of the tiny blood vessels that nourish a child's nerves, which can cause tingling, numbness, burning or pain. Nerve damage usually occurs gradually over a long period of time.

Kidney damage: Diabetes can damage the numerous tiny blood vessel clusters that filter waste from blood.

Eye damage: Diabetes can damage the blood vessels of the retina.

Osteoporosis: Diabetes can lower normal bone mineral density, increasing the risk of osteoporosis as an adult.

Facts & Statistics for type 1 diabetes

Once diagnosed, type 1 diabetes is a lifelong disease that cannot be cured.
Every year, type 1 diabetes increases by 1.8% and type 2 diabetes increases by 4.8%.
If diabetes is not caught early, it can lead to seizures, coma and in extreme cases, death.
Number of adults with type 1 diabetes: 300,000 in Canada, 1.6 million in US and 71,000 in UK
Number of children & adolescents with type 1 diabetes: 33,000 in Canada, 210,000 in US and 29,000 in UK
On a global scale, 1.1 million children and adolescents live with type 1 diabetes.
000 children are diagnosed with type 1 diabetes each year.

Diabetes in Canada

There are currently 11 million people living with diabetes or prediabetes in Canada.

Since 2009, rates of type 1 and 2 diabetes have increased by 42%.

Ontario has more people living with diabetes or prediabetes than anywhere else in the country – just over 4.4 million.

Youth with type 2 diabetes develop complications more often than type 1 diabetic youth

The National Institute of Health and CDC funded a research study that discovered teens and young adults with type 2 diabetes develop kidney, nerve, and eye diseases (as well as some risk factors for heart disease), more often than their peers with type 1 diabetes in the years shortly after diagnosis.

Nearly 20% of youth with type 2 diabetes developed a sign of kidney disease by the end of the study compared to about 6% of youth with type 1 diabetes.
18% of youth with type 2 diabetes developed nerve disease compared to 9% of youth with type 1 diabetes.
9% of youth with type 2 diabetes developed eye disease compared to 6% of youth with type 1 diabetes.

“There’s often the assumption that young people don’t develop complications from diabetes, but that’s just not true. We saw that young people with diabetes are developing signs of major complications in the prime of their lives,” said Dr. Barbara Linder, study author and Senior Advisor for Childhood Diabetes Research within NIH’s National Institute of Diabetes and Digestive and Kidney Diseases.

The research study looked at factors such as glucose control, body mass index, waist-to-height ratio and blood pressure, but could not determine why children and youth with type 1 diabetes had more complications than type 2 diabetes.

“This study highlights the need for early monitoring for development of complications among young people with diabetes,” said Dr. Sharon Saydah, Senior Scientist at the CDC and an author of the study.

“Type 2 diabetes accounts for 90 to 95% of diabetes cases, and increasingly in children,” states Diabetes Canada.

Type 2 diabetes used to be very rare in children and teenagers but since the onslaught of the obesity epidemic in the 1970s, the numbers have increased significantly.

Cost of Insulin in Canada

Canadians pay about $35.00 per vial of insulin. Type 1 diabetes typically requires 2 or 3 vials of insulin monthly, but for people who are more resistant to insulin, such as those with Type 2 diabetes, 6 or more vials may be required.

Diabetics in Canada who do not have private insurance, can incur costs up to 27% of their annual income or $6,800.00.

The Canadian government does not provide health insurance coverage for syringes, blood-glucose test strips and alcohol swabs. Some people need to test their blood-glucose level 3 times a day and each strip costs about a $1.00.

“…57% of Canadians are not fully complying with their treatment plan because of high costs. Canadians with diabetes have reported that they estimate their glucose levels, take less insulin than required, and take oral medications fewer times daily or in lower doses to reduce costs,” says the Canadian Diabetic Association

GoFundMe pages are more common in the United States but are now showing up in Canada.