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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01421225
Recruitment Status : Completed
First Posted : August 22, 2011
Results First Posted : August 7, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Garry Steil, Boston Children’s Hospital

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: Closed-loop Insulin Pump therapy Device: Standard Insulin Pump Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Closed-Loop Insulin Delivery in Children Less Than 7 Years of Age
Study Start Date : August 2011
Actual Primary Completion Date : August 15, 2013
Actual Study Completion Date : August 15, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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 Name: Continuous glucose monitor and computer-linked insulin pump

Device: Standard Insulin Pump Therapy
Subjects insulin doses followed their usual home routine.
Other Name: 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 Name: Continuous glucose monitor and computer-linked insulin pump

Device: Standard Insulin Pump Therapy
Subjects insulin doses followed their usual home routine.
Other Name: Open-Loop Therapy




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 7 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01421225


Locations
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United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
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Principal Investigator: Andrew Dauber, MD Boston Children’s Hospital
Publications of Results:
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Responsible Party: Garry Steil, Assistant Professor of Pediatrics, Harvard Medical School, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT01421225    
Other Study ID Numbers: IRB-P00000231
First Posted: August 22, 2011    Key Record Dates
Results First Posted: August 7, 2018
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Garry Steil, Boston Children’s Hospital:
Closed Loop Insulin Delivery
Diabetes
Type 1 Diabetes
Artificial pancreas
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs