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

Overview

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.

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: August 15, 2013

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.

Interventions

• Device: Closed-loop Insulin Pump therapy
  • Subjects insulin doses were adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM – noon.
• Device: Standard Insulin Pump Therapy
  • Subjects insulin doses followed their usual home routine.

Arms, Groups and Cohorts

• Active Comparator: Standard Insulin Pump Therapy first, then Closed Loop
  • Standard therapy day 1, Closed-Loop therapy day 2.
• Active Comparator: Closed Loop first, then Standard Insulin Pump Therapy
  • Closed-loop therapy day 1, standard therapy day 2.

Clinical Trial Outcome Measures

Primary Measures

• Nocturnal Glycemic Control
  • Time Frame: 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 Measures

• Post-prandial Glycemic Control
  • Time Frame: 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
  • Time Frame: Participants will be followed for the duration of the 48 hour protocol
  • The number of interventions for hypoglycemia between 10 PM – 8 AM.
• Pre-lunch Blood Glucose Level
  • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 7 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Boston Children’s Hospital
• Provider of Information About this Clinical Study
  • Principal Investigator: Garry Steil, Assistant Professor of Pediatrics, Harvard Medical School – Boston Children’s Hospital
• Overall Official(s)
  • Andrew Dauber, MD, Principal Investigator, Boston Children’s Hospital

Citations Reporting on Results

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.