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

NCT07164768 | Enrolling By Invitation

• 1 other identifier: JCDC/BHR/24/034
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The Hirabai Cowasji Jehangir Medical Research Institute (HCJMRI), Pune, a Center of Excellence in type 1 diabetes (T1D), has extensive experience in studying prospective cohorts with high follow-up rates. HCJMRI maintains a registry of over 800 children with T1D, systematically assessing their glycemic control and diabetes-related complications. Given the high prevalence of T1D in India and the lack of studies on Indian children with T1D, the investigators aim to investigate cognitive function and mental health in children and youth with T1D compared to healthy controls, exploring key determinants of these outcomes. The investigators propose a cross-sectional, observational, case-control study involving children and youth aged 10-21 years with T1D and age- and gender-matched healthy controls from similar socio-economic backgrounds. Participants will be enrolled between July 2023 and July 2025, with assent from children and consent from parents. Those with neurodevelopmental disorders will be excluded. The investigators plan to recruit one in two eligible participants with T1D from our existing cohort, with a total sample size of 396 participants (264 cases and 132 controls), adequately powered to detect group differences with a moderate effect size. Data on T1D exposure will be extracted from ongoing cohort records. Outcomes assessed in both groups include:

1. 1.Cognitive functions - assessed using age-appropriate tests.
2. 2.Behavioral and emotional problems - evaluated in children, adolescents, and young adults.
3. 3.Quality of life - assessed using standardized tools. Potential confounders such as age, gender, socio-economic status, parental education, occupation, participant's education, and pubertal status will be considered. Random blood samples will be collected at the time of cognitive testing to measure plasma glucose, HbA1c, and Human-BDNF levels, examining associations between glycemic control and cognitive outcomes. Additionally, annual checkup data will be used to explore the impact of T1D complications on cognitive function.

Conditions

Type 1 Diabetes (T1D)

Keywords

Type 1 diabetes; children; cognitive function; behavioral and emotional problems; quality of life

Outcome Measures

Primary Outcomes (13)

• To assess intelligent quotient (IQ) as a cognitive function in children and youth with type 1 diabetes

  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.

  3 years

• To assess speed as a cognitive function in children and youth with type 1 diabetes

  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

  3 years

• To assess attention as a cognitive function in children and youth with type 1 diabetes

  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

  3 years

• To assess phonemic fluency as an executive function in children with type 1 diabetes

  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

  3 years

• To assess category fluency as an executive function in children with type 1 diabetes

  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

  3 years

• To assess phonemic fluency as an executive function in adolescents and youth with type 1 diabetes

  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

  3 years

• To assess category fluency as an executive function in adolescents and youth with type 1 diabetes

  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

  3 years

• To assess working memory as an executive function in children with type 1 diabetes

  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

  3 years

• To assess working memory as an executive function in adolescents and youth with type 1 diabetes

  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

  3 years

• To assess Shift of set (Wisconsin card sorting test) as an executive function in children and youth with type 1

  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.

  3 years

• To assess Response inhibition as an executive function in children and youth with type 1 diabetes

  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

  3 years

• To assess Verbal Learning and Memory as cognitive function in children and youth with type 1 diabetes

  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

  3 years

• To assess Test of comprehension as cognitive function in children and youth with type 1 diabetes

  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

  3 years

Secondary Outcomes (5)

• To assess mental health in children and youth with type 1 diabetes and their parents

  3 years

• To assess Diabetes related stress and quality of life in children and youth with type 1 diabetes

  3 years

• To assess parents' perception towards diabetes related stress and quality of life in their children

  3 years

• To assess general quality of life in children and youth with type 1 diabetes

  3 years

• To assess general quality of life in parents of children and youth with type 1 diabetes

  3 years

Study Arms (1)

Children and youth with type 1 diabetes (T1D) and their parents

The Hirabai Cowasji Jehangir Medical Research Institute (HCJMRI), Pune is a Center of Excellence in type 1 diabetes and has vast experience in studying prospective cohorts with good follow up rates. It also has a registry of more than 800 children with type 1 diabetes with systematic assessment of their glycemic control and micro and macrovascular complications due to type 1 diabetes. We would like to propose a cross sectional, observational, case control study in children with T1D and healthy controls of age 10-21 years (who give assent and parents give consent; children no neurodevelopmental disorders will be enrolled in the study) from similar socio-economic class as the children with diabetes. Approximate period of enrollment will be from July 2023 to July 2025. We expect to recruit one in two of participant with type 1 diabetes from our cohort and age gender matched healthy controls without type 1 diabetes.

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Study Subjects: The Hirabai Cowasji Jehangir Medical Research Institute, which is a sister concern of Jehangir hospital, Pune, has been involved in health related programs since its inception in 1995. Our major areas of work include Nutritional and Growth Disorders in Children, Type 1 Diabetes, Maternal and Child Health, Osteoporosis and Bone Health, Psychological Counseling, HIV and Cancers. Cases: There are 738 children registered with HCJMRI for the treatment and management of type 1 diabetes. The 'Sweetlings' programme is a charity clinic that provides holistic care to underprivileged children and youth with Type 1 Diabetes Mellitus (T1D). Currently, the clinic supports 548 children and youth with T1D aged 0 to 22 years in the Pune region of the Western Indian State of Maharashtra. From these, we have 386 children who are between 10-21 years of age. Controls: Siblings of these T1D children will be included as healthy age-matched controls for participation in this study. This wil

You may qualify if:

• Children, adolescents and young adults with T1D and their parents (caregiver, either mother or father)

You may not qualify if:

• Both parents are not alive or the child is not living with the parents and living with the grandparents.

Sponsors & Collaborators

• Hirabai Cowasji Jehangir Medical Research Institute: lead

Study Sites (1)

Hirabai Cowasji Jehangir Medical Research Institute

Pune, Maharashtra, 411001, India

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Aliquots of serum at -80°C for measurement of Human-BDNF.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Behavior

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Dr. Sonali S Wagle, M.Sc, RD, PhD

  Hirabai Cowasji Jehangir Medical Research Institute, Pune, India

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DEPUTY DIRECTOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: September 10, 2025
• Study Start: June 25, 2024
• Primary Completion (Estimated): June 25, 2027
• Study Completion (Estimated): June 25, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will become available 6 months after publication in a scientific journal and will remain accessible for the specified period decided by the principal investigator.
• Access Criteria: Access will be granted to researchers with a scientifically sound proposal that has been reviewed and approved by an independent review board. Requests should be directed to the principal investigator, Dr. Anuradha Khadilkar via email.

Locations

IN (1)