NCT03428932

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

May 16, 2023

Completed
Last Updated

May 16, 2023

Status Verified

July 1, 2019

Enrollment Period

1.4 years

First QC Date

January 24, 2018

Results QC Date

March 9, 2023

Last Update Submit

April 21, 2023

Conditions

Type 1 Diabetes Mellitus

Keywords

Insulin pumpClosed loopBrain developmentPediatricType 1 DiabetesMRICognitive development

Outcome Measures

Primary Outcomes (1)

  • Changes in Gray Matter Volume in the Brain

    Trends in total and regional grey matter volume

    6 months

Secondary Outcomes (2)

  • Changes in Brain Activation (Dorsal Anterior Cingulate, Inferior Frontal Gyrus and/or Parietal Cortex)

    6 months

  • Changes in WASI-II Perceptual Reasoning Index (PRI)

    6 months

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

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.

Other: Standard Care

Closed-Loop

ACTIVE COMPARATOR

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)

Interventions

Closed Loop (Medtronic 670G)DEVICE

A loaner Medtronic 670G insulin pump, Enlite 3 sensor and GST3C Guardian transmitter will be utilized

Closed-Loop
Standard CareOTHER

Subjects will continue on their current treatment (insulin pump or injections), with follow up every 3 months.

Standard Care

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Stanford University

Palo Alto, California, 94305, United States

Location

Yale University

New Haven, Connecticut, 06511, United States

Location

Nemours Childrens Clinic

Jacksonville, Florida, 32207, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Washington University St. Louis

St Louis, Missouri, 63126, United States

Location

Related Publications (12)

  • 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.

    PMID: 21790920BACKGROUND

  • 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.

    PMID: 27702833BACKGROUND

  • 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.

    PMID: 27339089BACKGROUND

  • 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.

    PMID: 26512024BACKGROUND

  • 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.

    PMID: 25488901BACKGROUND

  • 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.

    PMID: 24512675BACKGROUND

  • 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.

    PMID: 24319123BACKGROUND

  • 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.

    PMID: 21953611BACKGROUND

  • 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.

    PMID: 24879841BACKGROUND

  • 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.

    PMID: 24757227BACKGROUND

  • 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.

    PMID: 20133395BACKGROUND

  • 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.

    PMID: 36042217DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Nelly Mauras, MD
Organization
Nemours Children's Health
Nelly.Mauras@nemours.org
904-697-3674

Study Officials

  • Nelly Mauras, MD

    Nemours Children's Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2018

First Posted

February 12, 2018

Study Start

February 1, 2018

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

May 16, 2023

Results First Posted

May 16, 2023

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

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

Locations

US(5)