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

Not Applicable

Completed

Interventions: Device: Closed-loop Insulin Pump therapy
Device: Standard Insulin Pump Therapy

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Closed Loop first, then Standard Insulin Pump Therapy	Standard Insulin Pump Therapy	Closed-loop therapy day 1, standard therapy day 2.
Standard Insulin Pump Therapy first, then Closed Loop	Closed-loop Insulin Pump therapy	Standard therapy day 1, Closed-Loop therapy day 2.
Standard Insulin Pump Therapy first, then Closed Loop	Standard Insulin Pump Therapy	Standard therapy day 1, Closed-Loop therapy day 2.
Closed Loop first, then Standard Insulin Pump Therapy	Closed-loop Insulin Pump therapy	Closed-loop therapy day 1, standard therapy day 2.

Primary Outcome Measures

Name	Time	Method
Nocturnal Glycemic Control	Participants will be followed for the duration of the 48 hour protocol.	Time spent within target glucose range based on the glucose meter measurements between 10 PM and 8 AM. The target range is 110-200 mg/dl as this is the American Diabetes Association defined target overnight range for this age group.

Secondary Outcome Measures

Name	Time	Method
Pre-lunch Blood Glucose Level	Participants will be followed for the duration of the 48 hour protocol	Blood glucose levels were documented at 12 pm just prior to being served lunch.
Post-prandial Glycemic Control	Participants will be followed for the duration of the 48 hour protocol	Peak post-prandial blood sugar between 8 AM and noon
Number of Interventions for Hypoglycemia	Participants will be followed for the duration of the 48 hour protocol	The number of interventions for hypoglycemia between 10 PM - 8 AM.