Closed-Loop Insulin Delivery in Children Less Than 7 Years of Age



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:Any - 7
Updated:8/11/2018
Start Date:August 2011
End Date:August 15, 2013

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The investigators are conducting this study to find out whether a new device can control
blood sugar levels in children who have Type 1 diabetes. In Type 1 diabetes, children have
high blood sugar levels because they do not make enough insulin. The standard treatment is to
give insulin either by shots or using an insulin pump. A new device, called closed-loop
insulin therapy, uses a continuous glucose monitor (CGMs) linked to an insulin pump by a
computer. The CGM will send the sugar levels to a computer which automatically figures out
how much insulin to give and then gives that amount of insulin through the insulin pump. It
will give the child insulin to bring sugar levels down if they are high, and will give less
insulin if the child's blood sugar is getting lower. Earlier research using closed-loop
insulin therapy has shown the ability for it to improve diabetes care in adults and older
children, but there has been no research of closed-loop insulin therapy in young children.
This study will compare children's current insulin therapy with the closed-loop system. The
knowledge that the investigators gain from this research will help us to figure out whether
closed-loop therapy can work in young children, hopefully leading to better Type 1 diabetes
care.

We will perform a randomized cross-over study of semi-closed-loop insulin therapy in children
less than 7 years old with type 1 diabetes. Subjects will be admitted to the inpatient
clinical research center for 48 hours. They will receive their standard home insulin therapy
for one day and semi-closed-loop insulin therapy for the other day.

Inclusion Criteria:

- Age < 7 years old

- Type 1 Diabetes (as diagnosed by outpatient endocrinologist) with duration greater
than 6 months

- Treated with insulin pump therapy for greater than 6 weeks

Exclusion Criteria:

- Any other chronic medical condition

- Weight below 10 kg as this is the minimal required weight for the amount of blood
being drawn
We found this trial at
1
site
Boston, Massachusetts 02115
Principal Investigator: Andrew Dauber, MD
Phone: 617-919-2189
?
mi
from
Boston, MA
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