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

Boston Children's Hospital

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Device: Closed-loop Insulin Pump therapy; Device: Standard Insulin Pump Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01421225

IRB-P00000231

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 6 months to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Standard Insulin Pump Therapy first, then Closed Loop

Active Comparator group

Description:

Standard therapy day 1, Closed-Loop therapy day 2.

Treatment:

Device: Standard Insulin Pump Therapy

Device: Closed-loop Insulin Pump therapy

Closed Loop first, then Standard Insulin Pump Therapy

Active Comparator group

Description:

Closed-loop therapy day 1, standard therapy day 2.

Treatment:

Device: Standard Insulin Pump Therapy

Device: Closed-loop Insulin Pump therapy