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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Children's Hospital Boston.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Andrew Dauber, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01421225
First received: August 19, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Procedure: Closed-loop therapy
Procedure: Standard Insulin Pump Therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Closed-Loop Insulin Delivery in Children Less Than 7 Years of Age

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Nocturnal Glycemic Control [ Time Frame: Participants will be followed for the duration of the 48 hour protocol ] [ Designated as safety issue: No ]
    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

  • Post-prandial glycemic control [ Time Frame: Participants will be followed for the duration of the 48 hour protocol ] [ Designated as safety issue: No ]
    Peak post-prandial blood sugar between 8 AM and 12 PM based on glucose meter measurement


Secondary Outcome Measures:
  • Nocturnal hypoglycemia and hyperglycemia [ Time Frame: Participants will be followed for the duration of the 48 hour protocol ] [ Designated as safety issue: Yes ]
    The number of episodes of either hypoglycemia or hyperglycemia requiring intervention between 10 PM - 8 AM.

  • Continuous glucose monitor accuracy [ Time Frame: Participants will be followed for the duration of the 48 hour protocol ] [ Designated as safety issue: No ]
    Mean relative absolute differences between contiuous glucose monitor measured glucose and venous glucose value

  • Daytime hypoglycemia and hyperglycemia [ Time Frame: Participants will be followed for the duration of the 48 hour protocol ] [ Designated as safety issue: Yes ]
    The number of episodes of either hypoglycemia or hyperglycemia requiring intervention between 8 AM - 12 PM.


Estimated Enrollment: 15
Study Start Date: August 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard Therapy First
The subjects in this arm received standard therapy on day 1 followed by closed-loop therapy on day 2.
Procedure: Closed-loop therapy
Subjects' insulin dose will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon.
Procedure: Standard Insulin Pump Therapy
Patients will receive standard insulin pump therapy as per their usual home insulin protocol.
Experimental: Closed-Loop Therapy First
The subjects in this arm receive closed-loop therapy on day 1 followed by standard therapy on day 2.
Procedure: Closed-loop therapy
Subjects' insulin dose will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon.
Procedure: Standard Insulin Pump Therapy
Patients will receive standard insulin pump therapy as per their usual home insulin protocol.

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.

  Eligibility

Ages Eligible for Study:   6 Months to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421225

Contacts
Contact: Jason M Safer, B.S. 6179192189 Jason.Safer@childrens.harvard.edu
Contact: Andrew Dauber, MD 6179192413 andrew.dauber@childrens.harvard.edu

Locations
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jason Safer, BS    617-919-2189    jason.safer@childrens.harvard.edu   
Contact: Andrew Dauber, MD MMSc    6179192413    andrew.dauber@childrens.harvard.edu   
Principal Investigator: Andrew Dauber, MD         
Sub-Investigator: Garry Steil, PhD         
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Andrew Dauber, MD Children's Hospital Boston
  More Information

No publications provided by Children's Hospital Boston

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrew Dauber, Attending Physician, Division of Endocrinology, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01421225     History of Changes
Other Study ID Numbers: IRB-P00000231
Study First Received: August 19, 2011
Last Updated: August 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Closed Loop Insulin Delivery
Diabetes
Type 1 Diabetes
Artificial pancreas

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014