Skip to main content
OpenTrials
Completed

NCT Number: NCT01421225

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

6 month–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closed-loop Insulin Pump therapy

Device

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

Other names: Continuous glucose monitor and computer-linked insulin pump

Standard Insulin Pump Therapy

Device

Subjects insulin doses followed their usual home routine.

Other names: Open-Loop Therapy

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 22, 2011
Registry last updated
Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.