- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03428932
Glycemic Control and the Brain in Children With Type 1 Diabetes
April 21, 2023 updated by: Nemours Children's Clinic
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
46
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
-
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California
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Palo Alto, California, United States, 94305
- Stanford University
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Connecticut
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New Haven, Connecticut, United States, 06511
- Yale University
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Florida
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Jacksonville, Florida, United States, 32207
- Nemours Childrens Clinic
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa
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Missouri
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Saint Louis, Missouri, United States, 63126
- Washington University St. Louis
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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
14 years to 17 years (Child)
Accepts Healthy Volunteers
No
Description
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
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: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
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Subjects will continue on their current treatment (insulin pump or injections), with follow up every 3 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.
|
A loaner Medtronic 670G insulin pump, Enlite 3 sensor and GST3C Guardian transmitter will be utilized
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Gray Matter Volume in the Brain
Time Frame: 6 months
|
Trends in total and regional grey matter volume
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Brain Activation (Dorsal Anterior Cingulate, Inferior Frontal Gyrus and/or Parietal Cortex)
Time Frame: 6 months
|
Blood Oxygen level diffusion (BOLD) Functional Magnetic Resonance Imaging (fMRI) was measured to assess functional activation occurring during "no-go" relative to "go" trials during a Go/No-Go cognitive task.
Parameter estimates for an individual subject are obtained by modeling the subject's BOLD time series at each voxel against the expected BOLD response to a given task.
Statistical weights (i.e., parameter estimates of activation strength) are determined based on how closely the observed and expected signals agree for each task condition to create parameter maps over the entire brain.
Higher-level parameter estimates are generated via contrasts of the estimates from specific task conditions, which can lead to positive or negative values, depending on the relative activation of the conditions.
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6 months
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Changes in WASI-II Perceptual Reasoning Index (PRI)
Time Frame: 6 months
|
The Wechsler Abbreviated Scale of Intelligence second edition (WASI-II) was used.
The WASI-II is composed of four subtests: Block Design, Vocabulary, Matrix Reasoning, and Similarities.
The WASI-II used in this study produces a Perceptual Reasoning Index (PRI) score from the Block Design and Matrix Reasoning subtests' age-corrected scaled scores.
The index scores are derived from a summation of the comprising scaled scores.
The PRI score range is: 50-150.
Higher scores mean better outcomes.
Change over time in the PRI score is reported in each group.
|
6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nelly Mauras, MD, Nemours Children's Clinic
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
- Mazaika PK, Weinzimer SA, Mauras N, Buckingham B, White NH, Tsalikian E, Hershey T, Cato A, Aye T, Fox L, Wilson DM, Tansey MJ, Tamborlane W, Peng D, Raman M, Marzelli M, Reiss AL; Diabetes Research in Children Network (DirecNet). Variations in Brain Volume and Growth in Young Children With Type 1 Diabetes. Diabetes. 2016 Feb;65(2):476-85. doi: 10.2337/db15-1242. Epub 2015 Oct 28.
- Mauras N, Mazaika P, Buckingham B, Weinzimer S, White NH, Tsalikian E, Hershey T, Cato A, Cheng P, Kollman C, Beck RW, Ruedy K, Aye T, Fox L, Arbelaez AM, Wilson D, Tansey M, Tamborlane W, Peng D, Marzelli M, Winer KK, Reiss AL; Diabetes Research in Children Network (DirecNet). Longitudinal assessment of neuroanatomical and cognitive differences in young children with type 1 diabetes: association with hyperglycemia. Diabetes. 2015 May;64(5):1770-9. doi: 10.2337/db14-1445. Epub 2014 Dec 8.
- Hovorka R, Elleri D, Thabit H, Allen JM, Leelarathna L, El-Khairi R, Kumareswaran K, Caldwell K, Calhoun P, Kollman C, Murphy HR, Acerini CL, Wilinska ME, Nodale M, Dunger DB. Overnight closed-loop insulin delivery in young people with type 1 diabetes: a free-living, randomized clinical trial. Diabetes Care. 2014;37(5):1204-11. doi: 10.2337/dc13-2644.
- Barnea-Goraly N, Raman M, Mazaika P, Marzelli M, Hershey T, Weinzimer SA, Aye T, Buckingham B, Mauras N, White NH, Fox LA, Tansey M, Beck RW, Ruedy KJ, Kollman C, Cheng P, Reiss AL; Diabetes Research in Children Network (DirecNet). Alterations in white matter structure in young children with type 1 diabetes. Diabetes Care. 2014 Feb;37(2):332-40. doi: 10.2337/dc13-1388. Epub 2013 Dec 6.
- Perantie DC, Koller JM, Weaver PM, Lugar HM, Black KJ, White NH, Hershey T. Prospectively determined impact of type 1 diabetes on brain volume during development. Diabetes. 2011 Nov;60(11):3006-14. doi: 10.2337/db11-0589. Epub 2011 Sep 27.
- Ly TT, Breton MD, Keith-Hynes P, De Salvo D, Clinton P, Benassi K, Mize B, Chernavvsky D, Place J, Wilson DM, Kovatchev BP, Buckingham BA. Overnight glucose control with an automated, unified safety system in children and adolescents with type 1 diabetes at diabetes camp. Diabetes Care. 2014 Aug;37(8):2310-6. doi: 10.2337/dc14-0147. Epub 2014 May 30.
- Cato MA, Mauras N, Ambrosino J, Bondurant A, Conrad AL, Kollman C, Cheng P, Beck RW, Ruedy KJ, Aye T, Reiss AL, White NH, Hershey T; Diabetes Research in Children Network (DirecNet). Cognitive functioning in young children with type 1 diabetes. J Int Neuropsychol Soc. 2014 Feb;20(2):238-47. doi: 10.1017/S1355617713001434.
- Bjorgaas MR. Cerebral effects of severe hypoglycemia in young people with type 1 diabetes. Pediatr Diabetes. 2012 Feb;13(1):100-7. doi: 10.1111/j.1399-5448.2011.00803.x. Epub 2011 Jul 25. No abstract available.
- Saggar M, Tsalikian E, Mauras N, Mazaika P, White NH, Weinzimer S, Buckingham B, Hershey T, Reiss AL; Diabetes Research in Children Network (DirecNet). Compensatory Hyperconnectivity in Developing Brains of Young Children With Type 1 Diabetes. Diabetes. 2017 Mar;66(3):754-762. doi: 10.2337/db16-0414. Epub 2016 Oct 4.
- Hosseini SM, Mazaika P, Mauras N, Buckingham B, Weinzimer SA, Tsalikian E, White NH, Reiss AL; Diabetes Research in Children Network (DirecNet). Altered Integration of Structural Covariance Networks in Young Children With Type 1 Diabetes. Hum Brain Mapp. 2016 Nov;37(11):4034-4046. doi: 10.1002/hbm.23293.
- Gazdzinski S, Durazzo TC, Mon A, Yeh PH, Meyerhoff DJ. Cerebral white matter recovery in abstinent alcoholics--a multimodality magnetic resonance study. Brain. 2010 Apr;133(Pt 4):1043-53. doi: 10.1093/brain/awp343. Epub 2010 Feb 4.
- Reiss AL, Jo B, Arbelaez AM, Tsalikian E, Buckingham B, Weinzimer SA, Fox LA, Cato A, White NH, Tansey M, Aye T, Tamborlane W, Englert K, Lum J, Mazaika P, Foland-Ross L, Marzelli M, Mauras N; Diabetes Research in Children Network (DirecNet) Consortium. A Pilot randomized trial to examine effects of a hybrid closed-loop insulin delivery system on neurodevelopmental and cognitive outcomes in adolescents with type 1 diabetes. Nat Commun. 2022 Aug 30;13(1):4940. doi: 10.1038/s41467-022-32289-x.
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 (Actual)
February 1, 2018
Primary Completion (Actual)
July 1, 2019
Study Completion (Actual)
July 1, 2019
Study Registration Dates
First Submitted
January 24, 2018
First Submitted That Met QC Criteria
February 8, 2018
First Posted (Actual)
February 12, 2018
Study Record Updates
Last Update Posted (Actual)
May 16, 2023
Last Update Submitted That Met QC Criteria
April 21, 2023
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00000766
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
IPD Sharing Time Frame
After completion of the study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
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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