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

August 7, 2018 updated by: Garry Steil, Boston Children's Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 7 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard Insulin Pump Therapy first, then Closed Loop
Standard therapy day 1, Closed-Loop therapy day 2.
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.
Other Names:
  • Continuous glucose monitor and computer-linked insulin pump
Device: Standard Insulin Pump Therapy
Subjects insulin doses followed their usual home routine.
Other Names:
  • Open-Loop Therapy
ACTIVE_COMPARATOR: Closed Loop first, then Standard Insulin Pump Therapy
Closed-loop therapy day 1, standard therapy day 2.
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.
Other Names:
  • Continuous glucose monitor and computer-linked insulin pump
Device: Standard Insulin Pump Therapy
Subjects insulin doses followed their usual home routine.
Other Names:
  • Open-Loop Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Participants will be followed for the duration of the 48 hour protocol.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Participants will be followed for the duration of the 48 hour protocol
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.
Participants will be followed for the duration of the 48 hour protocol
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.
Participants will be followed for the duration of the 48 hour protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Investigators

  • Principal Investigator: Andrew Dauber, MD, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

August 15, 2013

Study Completion (ACTUAL)

August 15, 2013

Study Registration Dates

First Submitted

August 19, 2011

First Submitted That Met QC Criteria

August 19, 2011

First Posted (ESTIMATE)

August 22, 2011

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-P00000231

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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