Evidence map›Paper›PMID 40562562›Full record

ArticleBMJ open2025

Identifying lifelong factors that impact brain health and functional outcomes in adults with childhood-onset type 1 diabetes: the cognition and longitudinal assessments of risk factors over 30 years (CLARiFY) - diabetes complications study protocol.

Amy Brown, Stacey A Sakowski, Chris Moran, Emily J Koubek, Velandai K Srikanth, Lili Zhao, Taya Collyer, Chris L Adamson, Elisabeth A Northam, Richard Beare and 2 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Amy BrownMurdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Victoria, Australia.
Stacey A SakowskiDepartment of Neurology, University of Michigan, Ann Arbor, Michigan, USA.
Chris MoranNational Centre for Healthy Ageing, Frankston, Victoria, Australia.
Emily J KoubekDepartment of Neurology, University of Michigan, Ann Arbor, Michigan, USA.
Velandai K SrikanthNational Centre for Healthy Ageing, Frankston, Victoria, Australia.
Lili ZhaoPreventative Medicine - Biostatistics Division, Northwestern University, Chicago, Illinois, USA.
Taya CollyerNational Centre for Healthy Ageing, Frankston, Victoria, Australia.
Chris L AdamsonMurdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Victoria, Australia.
Elisabeth A NorthamMurdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Victoria, Australia.
Richard BeareMurdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Victoria, Australia.
Fergus J CameronMurdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Victoria, Australia.
Eva L FeldmanDepartment of Neurology, University of Michigan, Ann Arbor, Michigan, USA efeldman@umich.edu.ORCID http://orcid.org/0000-0002-9162-2694

Funding

Identifying lifelong factors that impact brain health and outcomes in type 1 diabetes: The Cognition and Longitudinal Assessments of Risk Factors over 30 Years (CLARiFY) Diabetes Complications StudyR01DK129320 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI FELDMAN, EVA LUCILLE · 2021 to 2025
$2.3M
NIDDK NIH HHS R01 DK129320
6 · The paper itself

Abstract

introductionType 1 diabetes (T1D) is associated with changes in brain structure, cognition, mental health, and functional outcomes. While these changes have been linked to dysregulated glycaemic control, findings are inconsistent, and their long-term impact remains unclear. Most evidence comes from cross-sectional or short-term longitudinal studies, limiting insights into causal associations. To address this, we aim to study individuals with T1D approximately 30 years after onset to assess how early dysglycaemic insults during neurodevelopment influence cognitive and functional outcomes in mid-adulthood. METHODS AND ANALYSIS: This protocol paper outlines an observational, case/control, cross-sectional/longitudinal and descriptive study that follows up the original Royal Children's Hospital (RCH) Diabetes Cohort Study. The initial study recruited children in Australia diagnosed with T1D between 1990 and 1992, conducting five waves of data collection. We now introduce the Cognition and Longitudinal Assessments of Risk Factors over 30 Years (CLARiFY) Diabetes Complications Study to assess brain, cognition and functional outcomes in mid-adulthood, approximately 30 years post-T1D onset. Both T1D participants from the original cohort and healthy controls will participate in semistructured interviews, neuroimaging and cognitive testing. T1D participants will also undergo complications screening. Data from this study and previous waves will be used to (Aim 1) explore cross-sectional and longitudinal impacts of T1D on brain health over 30 years. Linear regression will analyse cross-sectional outcomes, and multivariate analysis will assess cognitive variables jointly. Longitudinal outcomes will be examined using linear mixed-effects regression for IQ patterns, with secondary outcomes analysed via generalised linear models. Additionally, linear mixed-effects regression (Aim 2) will identify T1D-related metabolic factors affecting brain outcomes, with covariate selection informed by the construction of directed acyclic graphs (DAGs). ETHICS AND DISSEMINATION: The study was approved by the Royal Children's Hospital Human Research Ethics Committee (HREC 35 240F and 2019.065). The research findings will be disseminated through peer-reviewed publications, conference presentations, and print and social media. Participants will receive a summary of the study findings on its completion.

Indexed as

BrainCognitionDiabetes Mellitus, Type 1AdolescentAdultAustraliaCase-Control StudiesChildCross-Sectional StudiesFemaleHumansLongitudinal StudiesMaleObservational Studies as TopicResearch DesignRisk FactorsClinical ProtocolsCognitionDIABETES & ENDOCRINOLOGYEPIDEMIOLOGIC STUDIES

Identifiers

PMID40562562
PMCPMC12198799

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.