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

NCT01421225 | Completed Results FDA Device

• 1 other identifier: IRB-P00000231
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Closed Loop Insulin Delivery; Diabetes; Type 1 Diabetes; Artificial pancreas

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Post-prandial Glycemic Control

  Participants will be followed for the duration of the 48 hour protocol

• Number of Interventions for Hypoglycemia

  Participants will be followed for the duration of the 48 hour protocol

• Pre-lunch Blood Glucose Level

  Participants will be followed for the duration of the 48 hour protocol

Study Arms (2)

Standard Insulin Pump Therapy first, then Closed Loop

ACTIVE COMPARATOR

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

Device: Closed-loop Insulin Pump therapy; Device: Standard Insulin Pump Therapy

Closed Loop first, then Standard Insulin Pump Therapy

ACTIVE COMPARATOR

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

Device: Closed-loop Insulin Pump therapy; Device: Standard Insulin Pump Therapy

Interventions

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.

Also known as: Continuous glucose monitor and computer-linked insulin pump

Closed Loop first, then Standard Insulin Pump Therapy; Standard Insulin Pump Therapy first, then Closed Loop

Standard Insulin Pump Therapy DEVICE

Subjects insulin doses followed their usual home routine.

Also known as: Open-Loop Therapy

Closed Loop first, then Standard Insulin Pump Therapy; Standard Insulin Pump Therapy first, then Closed Loop

Eligibility Criteria

• Age: 6 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Any other chronic medical condition
• Weight below 10 kg as this is the minimal required weight for the amount of blood being drawn

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related 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.

  PMID: 23033237 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Garry Steil (Assistant Prof. of Pediatrics)
• Organization: Boston Children's Hospital

garry.steil@childrens.harvard.edu

617-355-7504

Study Officials

• Andrew Dauber, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics, Harvard Medical School

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: August 22, 2011
• Study Start: August 1, 2011
• Primary Completion: August 15, 2013
• Study Completion: August 15, 2013
• Last Updated: August 9, 2018
• Results First Posted: August 7, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)