Cognitive Function and Mental Health in Children and Youth With Type 1 Diabetes (T1D)

NCT07164768, Enrolling by invitation, Hirabai Cowasji Jehangir Medical Research Institute

Trial 8

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Field	Value	Source
Title	Cognitive Function and Mental Health in Children and Youth With Type 1 Diabetes (T1D)	ClinicalTrials.gov
NCT number	NCT07164768	ClinicalTrials.gov
Status	Enrolling by invitation	ClinicalTrials.gov
Enrollment	400 participants, estimated	ClinicalTrials.gov
Lead sponsor	Hirabai Cowasji Jehangir Medical Research Institute	ClinicalTrials.gov
Conditions	Type 1 Diabetes (T1D)	ClinicalTrials.gov
First posted	2025-09-10	ClinicalTrials.gov
Last updated	2025-09-10	ClinicalTrials.gov

Registered outcomes 18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description	Source
Primary	To assess intelligent quotient (IQ) as a cognitive function in children and youth with type 1 diabetes	3 years	Age range: 4 to 90 years. Raven's Colored Progressive Matrices: Raven's Progressive Matrices (often referred to simply as Raven's Matrices) to measure general human intelligence and abstract reasoning and is regarded as a non-verbal estimate of fluid intelligence. The Raven's 2 is a nonverbal assessment of general cognitive ability, including the ability to formulate new concepts when faced with novel information, extract meaning out of confusion or ambiguity, and think clearly about complex situation and events. It comprises 60 multiple-choice questions, listed in order of increasing difficulty. This format is designed to measure the test taker's reasoning ability, the eductive ("meaning-making") component of Spearman's g (g is often referred to as general intelligence). It is a measure of verbal and nonverbal generalized cognitive ability.	ClinicalTrials.gov
Primary	To assess speed as a cognitive function in children and youth with type 1 diabetes	3 years	Finger-Tapping Test Age Range: 9 years and above Procedure: The test uses an adapted electric finger-tapping instrument and monitor to record the number of taps. The participant taps a mounted key as rapidly as possible using the index finger of the dominant hand, followed by the non-dominant hand. Five consecutive 10-second trials are conducted for each hand. A 30-second break is given after the third trial to minimize fatigue. A practice trial is provided before the test begins. Scoring: The number of taps per 10-second trial is recorded separately for each hand. The mean number of taps across five trials is calculated for each hand. Material: Finger-tapping instrument and stopwatch Duration: 5 minutes	ClinicalTrials.gov
Primary	To assess attention as a cognitive function in children and youth with type 1 diabetes	3 years	d2 Test of Attention Age Range: 9-60 years Procedure: The d2 test assesses selective attention and concentration. It can be administered individually or in groups using a single test form. The form includes sections for subject data, test scores, and a practice sample. The standardized test consists of 14 lines, each with 47 characters (total: 658 items). Participants scan each line and cross out all "d's" with two dashes. Each line is timed for 20 seconds. Reliability \& Validity: The test demonstrates high reliability (r \> 0.90) across various indices (TN, TN-E, CP) and is supported by extensive research. Materials: 2 pencils (without erasers) and a stopwatch for the examiner. Duration: 10 minutes	ClinicalTrials.gov
Primary	To assess phonemic fluency as an executive function in children with type 1 diabetes	3 years	FAS Test (Children: 5-15 years) - A phonemic fluency test measuring verbal fluency. Participants generate words beginning with F, A, and S (or Ka, Pa, Ma for non-English speakers) within one minute per letter. Proper nouns are excluded. Score: Total admissible words. Duration: \~5 minutes	ClinicalTrials.gov
Primary	To assess category fluency as an executive function in children with type 1 diabetes	3 years	Animal Names Test (Children: 5-15 years) - A category fluency test where participants list as many animal names as possible in one minute, excluding fish, birds, and snakes. Score: Total unique words. Duration: \~5 minutes	ClinicalTrials.gov
Primary	To assess phonemic fluency as an executive function in adolescents and youth with type 1 diabetes	3 years	COWA Test (Adults: 15-65 years) - A phonemic fluency test where participants generate words beginning with F, A, and S (or Ka, Pa, Ma). Proper nouns and repeated words with different suffixes are excluded. Score: Average new words over three trials. Duration: \~5 minutes	ClinicalTrials.gov
Primary	To assess category fluency as an executive function in adolescents and youth with type 1 diabetes	3 years	Category Fluency: Animal Names Test (Adults: 15-65 years) - Same as the children's version, assessing category fluency. Score: Total unique words. Duration: \~5 minutes	ClinicalTrials.gov
Primary	To assess working memory as an executive function in children with type 1 diabetes	3 years	Digit \& Letter-Number (WISC) and Processing Speed: Coding \& Symbol Search (WISC) Age Range: 6-16 years Developed in 2003, this scale assesses intellectual ability. The Working Memory Index (WMI) includes Digit Span, Letter-Number Sequencing, and Arithmetic (supplemental). The Processing Speed Index (PSI) includes Coding, Symbol Search, and Cancellation (supplemental). Digit Span: The child repeats numbers in the same or reverse order. Letter-Number Sequencing: The child recalls numbers in ascending and letters in alphabetical order. Symbol Search: The child scans a group to identify target symbols within a time limit. Duration: 10 minutes	ClinicalTrials.gov
Primary	To assess working memory as an executive function in adolescents and youth with type 1 diabetes	3 years	Working Memory \& Processing Speed (WAIS) Age Range: 16-90 years The WMI measures working memory, attention, concentration, and reasoning, while the PSI assesses the ability to scan, sequence, and process visual information quickly. Both indices involve cognitive decision-making beyond simple reaction time. Duration: 20 minutes	ClinicalTrials.gov
Primary	To assess Shift of set (Wisconsin card sorting test) as an executive function in children and youth with type 1	3 years	Wisconsin Card Sorting Test (WCST-64) Age Range: 6 years 5 months to 89 years The WCST-64 assesses abstract reasoning and executive functions, including cognitive flexibility, goal-directed behavior, planning, and impulse control. Unlike the full WCST, which uses 128 cards, the WCST-64 uses 64 cards. Participants match stimulus cards without explicit instructions, receiving feedback on correctness. The test generates psychometric scores on categories achieved, trials, errors, and perseverative errors. Materials: Four stimulus cards, 64 response cards, and a record form. Duration: 20-30 minutes The WCST has demonstrated reliability and validity across various populations, including individuals with autism, stroke survivors, pediatric groups, and psychiatric patients.	ClinicalTrials.gov
Primary	To assess Response inhibition as an executive function in children and youth with type 1 diabetes	3 years	Stroop Test Age Range: Children (5-14 years), Adults (15+ years) The Stroop Test measures response inhibition, assessing the ability to suppress habitual responses in favor of unusual ones. It evaluates cognitive flexibility and prefrontal function. Participants are shown a sheet with color names ("Blue," "Green," "Red") printed in different ink colors. They first read the words column-wise as quickly as possible while the time is recorded. Next, they name the ink color instead of reading the word, with the time again recorded. Score: The Stroop effect score is calculated as: Stroop Effect Score = Time to name colors - Time to read words Uncorrected errors are recorded separately for both phases. Duration: \~20 minutes	ClinicalTrials.gov
Primary	To assess Verbal Learning and Memory as cognitive function in children and youth with type 1 diabetes	3 years	Verbal Learning \& Memory: Auditory Verbal Learning Test (AVLT) Age Range: Children (5-15 years), Adults (16-65 years) The AVLT assesses verbal learning and memory using word lists. Adapted by WHO for different cultures, it includes Lists A \& B with 15 familiar words each, translated into Kannada, Tamil, Telugu, and Hindi. Words from List A are presented at a rate of one per second for five trials, with recall recorded after each trial. Then, List B is introduced as an interference task, followed by immediate recall of List A. After 20 minutes, delayed recall of List A is assessed without re-presentation. Finally, a recognition test is conducted by mixing List A words with new words, recording hits and errors. Words are presented in the participant's preferred language (mother tongue or English). Duration: 15 minutes	ClinicalTrials.gov
Primary	To assess Test of comprehension as cognitive function in children and youth with type 1 diabetes	3 years	Test of Comprehension: Token Test Age Range: Children (5-15 years), Adults (16-65 years) The Token Test assesses verbal comprehension using tokens that vary in color, size, and shape. Participants follow spoken instructions of increasing complexity. Squares and circles in two sizes and five colors are placed in a fixed arrangement. Instructions are given once per item, with up to two repetitions if needed. Scoring: One point is awarded for correct responses, with a 0.5-point deduction per repetition. A trial is failed if the participant does not follow instructions after two repetitions. The maximum score is 36. Duration: 20 minutes	ClinicalTrials.gov
Secondary	To assess mental health in children and youth with type 1 diabetes and their parents	3 years	CBCL (Child Behavior Checklist) Age Range: 6-18 years The CBCL is part of the Achenbach System of Empirically Based Assessment (ASEBA) and detects behavioral and emotional problems in children. It is completed by parents, while the Teacher's Report Form (TRF) is completed by teachers, and the Youth Self-Report (YSR) by the child. The CBCL/6-18 includes eight syndrome scales: Anxious/Depressed, Depressed, Somatic Complaints, Social Problems, Thought Problems, Attention Problems, Rule-Breaking Behavior, and Aggressive Behavior. These form two higher-order factors: Internalizing and Externalizing. Responses cover the past six months. BSI (Brief Symptom Inventory) Age Range: 18 years and above The BSI has 53 items covering nine symptom dimensions, including Somatization, Obsession-Compulsion, Depression, Anxiety, and Psychoticism. It also includes three global indices measuring symptom severity, distress intensity, and total reported symptoms.	ClinicalTrials.gov
Secondary	To assess Diabetes related stress and quality of life in children and youth with type 1 diabetes	3 years	The PedsQL Diabetes Module is a standardized tool designed to assess diabetes-related quality of life in children and adolescents with diabetes. It evaluates the impact of diabetes on various aspects of daily life, including treatment barriers, adherence, worry, and communication with healthcare providers. The module is structured for self-report by children and proxy-report by parents, covering emotional, social, and physical challenges associated with diabetes management. By identifying specific areas of distress and difficulty, the PedsQL Diabetes Module helps healthcare professionals tailor interventions to improve both medical outcomes and overall well-being in pediatric diabetes patients.	ClinicalTrials.gov
Secondary	To assess parents' perception towards diabetes related stress and quality of life in their children	3 years	Diabetes related stress and quality of life in children and parents' perception towards quality of life in their children will be assessed using standard questionnaires developed by The PedsQL™ Diabetes Module is a specific module of the PedsQL™	ClinicalTrials.gov
Secondary	To assess general quality of life in children and youth with type 1 diabetes	3 years	PedsQL Generic Core Scale will be used to measure generic health-related quality of life of the children, adolescnts and young adults in this study. This scale is applicable for healthy school and community populations, as well as patient populations with acute and chronic health conditions.	ClinicalTrials.gov
Secondary	To assess general quality of life in parents of children and youth with type 1 diabetes	3 years	PedsQL Generic Core Scale\[18\] will be used to measure generic health-related quality of life of the primary caregiver (any one parent, either mother or father). This scale is applicable for healthy school and community populations, as well as patient populations with acute and chronic health conditions. 4\. Parental education and occupation: This information will be collected using standard questionnaires for general information.	ClinicalTrials.gov

Outcomes 0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as	Source

Results by group 0

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units	Source

Participant flow 0

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Units counted	Source

Adverse events 0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events	Source

Adverse event totals 0

The totals the trial posted for each group.

Total	Group	Affected	At risk	Source

Papers 1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
42829215	DERIVED	PubMed

Trial comparisons 0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source

Tests 13

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Cancellation Test	Primary outcome	ConductCognition
Card Sorting Test (Berg)	Primary outcome	ConductCognition
Category Fluency	Primary outcome	ConductCognition
Digit Span Test	Primary outcome	ConductCognition
Finger Tapping Task	Primary outcome	ConductCognition
Letter-Number Sequencing Task	Primary outcome	ConductCognition
Matrix Reasoning	Primary outcome	ConductCognition
Simple Reaction Time	Primary outcome	ConductCognition
Stroop Color-Word Test	Primary outcome	ConductCognition
Symbol Scan Task	Primary outcome	ConductCognition
Token Commands Task	Primary outcome	ConductCognition
Verbal Fluency	Primary outcome	ConductCognition
Verbal Learning	Primary outcome	ConductCognition

Source 4

Field	Value	Source
Release	trials-2026-11-12-0.3.0	ClinicalTrials.gov
Release manifest SHA-256	4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391	ClinicalTrials.gov
Registry capture	2026-11-12	ClinicalTrials.gov
Results copy, AACT	2026-03-23	ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.3.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.