ClinicalTrials.gov
ClinicalTrials.gov Menu

Glycemic Control and the Brain in Children With Type 1 Diabetes

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03428932
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : February 12, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Washington University School of Medicine
Stanford University
University of Iowa
Yale University
Jaeb Center for Health Research
Information provided by (Responsible Party):
Nemours Children's Clinic

Brief Summary:
The purpose of this study is to determine if improving diabetes control by better controlling blood sugars, will help improve or normalize brain function as compared to routine diabetes care. We will use either the patient's own insulin routine (injections or insulin pumps) or a closed-loop insulin pump (Medtronic 670G). This system uses a continuous glucose monitor (CGM) and an insulin pump to automatically give insulin and may improve control of blood sugars.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: Closed Loop (Medtronic 670G) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Glycemic Control and the Brain in Children With Type 1 Diabetes
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
No Intervention: Standard Care
Subjects will continue on their current treatment (insulin pump or injections), with follow up every 3 months. Neurocognitive testing and brain MRI/fMRI will be done at enrollment and 6 months.
Active Comparator: Closed-Loop
Subjects will transition from their current treatment (insulin pump or injections) onto the Medtronic 670G insulin pump (intervention arm as a comparator) and will have close contact with the study team. Neurocognitive testing and brain MRI/fMRI will be done at enrollment and 6 months.
Device: Closed Loop (Medtronic 670G)
A loaner Medtronic 670G insulin pump, Enlite 3 sensor and GST3C Guardian transmitter will be utilized




Primary Outcome Measures :
  1. Changes in grey and white matter volumes in the brain [ Time Frame: 6 months ]
    Trends in total and regional grey and white matter volumes and white matter microstructure (FA)


Secondary Outcome Measures :
  1. Changes in BOLD fMRI [ Time Frame: 6 months ]
  2. Changes in neurocognitive metrics [ Time Frame: 6 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be at least 14 and not yet 18 years old
  • Must have been diagnosed with T1D prior to 5 years old but after 6 months
  • For those diagnosed prior to 1 year of age, a positive blood test for an antibody marker will be required
  • Have been born term or near term (≥34 weeks) and weighed more than≥ 2 kg (4.4lbs) at birth
  • Be in puberty

Exclusion Criteria:

  • History of intellectual disability, language or learning disability identified before diagnosis of diabetes, or enrollment in a self-contained special education program
  • ADD/ADHD and/or on stimulant medication
  • Any known genetic or medical problem that could impair brain development
  • Abnormalities of the brain/nervous system, visual or hearing problem
  • History of seizures not associated with fever before diabetes diagnosis
  • Previous inpatient psychiatric treatment
  • Unable to have a MRI of the head due to having metal: including metal ear tubes, full set of braces in mouth (retainer is acceptable), other appliances, or vascular clip

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): NCT03428932


Contacts
Contact: Nelly Mauras, MD 904-697-3674 nmauras@nemours.org
Contact: Kaitlin M Sikes, ARNP 904-697-3988 ksikes@nemours.org

Locations
United States, California
Stanford University Not yet recruiting
Palo Alto, California, United States, 94305
Contact: Tali Jacobson    650-721-8782    talij@stanford.edu   
Principal Investigator: Bruce Buckingham, MD         
Sub-Investigator: Darrell Wilson, MD         
Sub-Investigator: Tandy Aye, MD         
United States, Connecticut
Yale University Not yet recruiting
New Haven, Connecticut, United States, 06511
Contact: Amy Steffen, RN    203-737-8852    amy.steffen@yale.edu   
Principal Investigator: Stuart Weinzimer, MD         
Sub-Investigator: William Tamborlane, MD         
United States, Florida
Nemours Childrens Clinic Recruiting
Jacksonville, Florida, United States, 32207
Contact: Kaitlin M Sikes, ARNP    904-697-3988    ksikes@nemours.org   
Contact: Kim Englert, RN    904-697-3056    kimberly.englert@nemours.org   
Principal Investigator: Nelly Mauras, MD         
Sub-Investigator: Larry Fox, MD         
United States, Missouri
Washington University St. Louis Not yet recruiting
Saint Louis, Missouri, United States, 63126
Contact: Lucy Levandoski, PA-C    314-454-6025    Levandoski_L@kids.wustl.edu   
Principal Investigator: Neil White, MD         
Sub-Investigator: Ana Maria Arbelaez, MD         
Sponsors and Collaborators
Nemours Children's Clinic
National Institutes of Health (NIH)
Washington University School of Medicine
Stanford University
University of Iowa
Yale University
Jaeb Center for Health Research
Investigators
Principal Investigator: Nelly Mauras, MD Nemours Children's Clinic

Publications:

Responsible Party: Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT03428932     History of Changes
Other Study ID Numbers: 00000766
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: In accordance with the NIH data sharing policy, a de-identified database will be placed in the public domain after the completion of the study. This will be timed if possible with publication of the manuscripts that will result from these studies. In addition, formal requests for data will be accepted and reviewed by the DirecNet Steering Committee. If the request is approved, the Data Coordinating Centers will provide the data in a format mutually agreeable to the requesting party.
Time Frame: After completion of the study

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Nemours Children's Clinic:
Insulin pump
Closed loop
Brain development
Pediatric
Type 1 Diabetes
MRI
Cognitive development

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