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

NCT ID: NCT01421225

Last Updated: 2018-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-08-15

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Insulin Pump Therapy first, then Closed Loop

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

Group Type: ACTIVE_COMPARATOR

Closed-loop Insulin Pump therapy

Intervention Type: DEVICE

Subjects insulin doses were adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon.

Standard Insulin Pump Therapy

Intervention Type: DEVICE

Subjects insulin doses followed their usual home routine.

Closed Loop first, then Standard Insulin Pump Therapy

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

Group Type: ACTIVE_COMPARATOR

Closed-loop Insulin Pump therapy

Intervention Type: DEVICE

Subjects insulin doses were adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon.

Standard Insulin Pump Therapy

Intervention Type: DEVICE

Subjects insulin doses followed their usual home routine.

Interventions

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.

Intervention Type: DEVICE

Standard Insulin Pump Therapy

Subjects insulin doses followed their usual home routine.

Intervention Type: DEVICE

Other Intervention Names

Continuous glucose monitor and computer-linked insulin pump; Open-Loop Therapy

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Garry Steil

Assistant Professor of Pediatrics, Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Dauber, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Children's Hospital Boston

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 23033237 (View on PubMed)

Other Identifiers

IRB-P00000231

Identifier Type: -

Identifier Source: org_study_id