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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01421225
• Other study ID #: IRB-P00000231
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: August 15, 2013

Study information

• Verified date: August 2018
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 15, 2013
• Est. primary completion date: August 15, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 7 Years

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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.
• Standard Insulin Pump Therapy
Subjects insulin doses followed their usual home routine.

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

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