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

Completed · Not applicable

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01421225

Run by

Boston Children's Hospital

People needed

10

Starts

2011-08-01

Expected to finish

2013-08-15

Last updated by the study team

2018-08-09

Who can join

Age: 1 and older, up to 7. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Any other chronic medical condition
• Weight below 10 kg as this is the minimal required weight for the amount of blood being drawn

Where it is running

• Children's Hospital Boston — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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