Clinical trial NCT01421225: Closed-Loop Insulin Delivery in Children Less Than 7 Years of Age
Official title: Closed-Loop Insulin Delivery in Children Less Than 7 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Closed Loop Insulin Delivery
Diabetes
Type 1 Diabetes
Artificial pancreas
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2011-08-22
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nocturnal Glycemic Control
timeFrame: Participants will be followed for the duration of the 48 hour protocol.
Secondary outcomes:
measure: Post-prandial Glycemic Control
timeFrame: Participants will be followed for the duration of the 48 hour protocol
measure: Number of Interventions for Hypoglycemia
timeFrame: Participants will be followed for the duration of the 48 hour protocol
measure: Pre-lunch Blood Glucose Level
timeFrame: Participants will be followed for the duration of the 48 hour protocol
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Andrew Dauber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dauber A, Corcia L, Safer J, Agus MS, Einis S, Steil GM. Closed-loop insulin therapy improves glycemic control in children aged <7 years: a randomized controlled trial. Diabetes Care. 2013 Feb;36(2):222-7. doi: 10.2337/dc12-1079. Epub 2012 Oct 1.