The Cognitive Protective Effect of VR-based Cognitive Training in Type 2 Diabetes Patients With Mild Cognitive Impairment

The Cognitive Protective Effect of VR-based Cognitive Training in Type 2 Diabetes Patients With Mild Cognitive Impairment：A Prospective, Randomized, Open-Label, Parallel-Group Pilot Study

We conducted a single-center, prospective, open-label, parallel-group randomized controlled trial to investigate the cognitive-protective efficacy of a novel, diabetes-specific virtual reality (VR)-based cognitive training system integrated with diet management modules, relative to frequency- and duration-matched traditional paper-and-pencil cognitive training, in adults aged 45-80 years with T2DM and amnestic/mixed mild cognitive impairment (MCI). A total of 40 eligible participants will be randomly assigned 1:1 to either the intervention group (16 weeks of individualized VR training with dynamic difficulty adjustment, 2 sessions/week, 30-60 minutes/session) or the active control group (standardized paper-and-pencil cognitive tasks). All participants will maintain stable glucose-lowering regimens for ≥3 months and receive standardized weekly diabetes health education. The primary endpoint is the between-group difference in the change in MoCA total score from baseline to the 16-week follow-up. Secondary endpoints include changes in individual cognitive domains (memory, executive function, attention, processing speed), olfactory threshold/identification/recall, brain structural volumes and resting-state functional connectivity (assessed via 3.0T fMRI), glycemic control (HbA1c, fasting/postprandial glucose), lipid profile, body composition, sleep quality, anxiety and depressive symptoms, and diabetes self-management behaviors. The safety and participant adherence to the VR intervention will also be systematically monitored.

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment (MCI); Type 2 Diabetes Mellitus (T2DM)
• Intervention / Treatment: Device: VR-Based Cognitive Training Plus Standard Diabetes Care; Other: Traditional Paper-and-Pencil Cognitive Training Plus Standard Diabetes Care

Detailed Description

As China's aging population continues to grow, type 2 diabetes Mellitus(T2DM) has become a serious health threat to the country's elderly. The risk of dementia among patients with T2DM rises rapidly with age. Mild cognitive impairment (MCI) is a critical transitional stage between normal aging and dementia; early intervention at this stage can effectively slow disease progression and reduce the risk of developing dementia. Against this backdrop, non-pharmacological interventions such as cognitive training have become a key pillar of early intervention due to their high safety profile and ease of implementation. Traditional paper-and-pencil cognitive training suffers from drawbacks such as a lack of immersive, real-world experiences and poor patient compliance. Virtual reality technology, with its immersive and interactive nature, has demonstrated promising results in the cognitive rehabilitation of patients with mild cognitive impairment; however, there is currently a lack of virtual reality cognitive training programs specifically designed for patients with T2DM who also have mild cognitive impairment.

This study is designed to evaluate the cognitive-protective efficacy of a customized VR-based cognitive training system integrated with diabetes self-management modules in adults with T2DM and MCI. The system combines multi-sensory cognitive training with diabetes diet management education, aiming to simultaneously improve cognitive function, metabolic parameters, and diabetes self-management ability in this patient population. The study will also systematically verify the safety and participant adherence of this customized VR training system.

A total of 40 eligible participants will be enrolled and randomized in a 1:1 ratio to either the VR cognitive training group or the traditional paper-and-pencil cognitive training group. The intervention period will last 16 weeks. All participants will maintain stable glucose-lowering regimens for at least 3 months prior to enrollment and throughout the study, and will receive standardized weekly diabetes health education. Both groups will be followed up weekly via verbal communication, telephone, or WeChat to monitor glycemic control, adverse events, and training adherence.

Participants in the VR cognitive training group will use a research team-developed customized VR cognitive training system, consisting of an HTC VIVE Pro Eye head-mounted display, handheld controllers, spatial positioning base stations, and a 360° rotating seat, with software developed based on the Unity3D engine. The system generates individualized training plans based on patients' metabolic parameters including height, weight, physical activity level, and diabetes duration, and dynamically adjusts training difficulty according to each session's task completion rate and response time. The training comprises four core modules: (1) VR supermarket/canteen module, which integrates diabetes diet management to train executive function, memory, and calculation skills; (2) multi-sensory object finding/difference detection module, which trains attention, visual span, and cross-modal association ability; (3) mindfulness healing garden module, which regulates emotional state through virtual natural scenes, soothing audio, and relaxing scents; (4) comprehensive cognitive training module, which targets memory and processing speed with tasks such as digit span and trail making tests. Training will be administered twice weekly for 30-60 minutes per session. Participants in the control group will receive frequency- and duration-matched paper-and-pencil cognitive training, with full guidance from research staff throughout each session.

Assessments will be performed at baseline and after 16 weeks of intervention, with interim follow-ups at 4, 8, and 12 weeks to evaluate training adherence and diabetes self-management ability. The primary endpoint is the between-group difference in the change in Montreal Cognitive Assessment (MoCA) total score from baseline to week 16. Secondary endpoints include changes in domain-specific cognitive functions (assessed by the Repeatable Battery for the Assessment of Neuropsychological Status [RBANS], digit span test, Stroop Color-Word Test, and Trail Making Test), olfactory function (olfactory threshold, identification, and recall scores), brain structural measurements and resting-state functional network connectivity (assessed via 3.0T functional magnetic resonance imaging [fMRI]), glycemic and lipid metabolic parameters (HbA1c, fasting and postprandial blood glucose, insulin, C-peptide, and lipid profile), body composition, sleep quality, anxiety and depressive symptoms, and diabetes self-management behaviors. Safety assessments will include monitoring the type, incidence, severity, and causality of adverse events throughout the study, as well as regular measurements of vital signs and laboratory parameters including liver and kidney function.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Bi, MD, PhD; Phone Number: 6-25-83-105302; Email: biyan@nju.edu.cn
• Study Contact Backup: Name: Zhou Zhang, MD, PhD; Phone Number: (86) 25-83106666; Email: zhangzhou@smail.nju.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School
      • Contact: Yan Bi, MD, PhD; Phone Number: 6-25-83-105302; Email: biyan@nju.edu.cn
      • Contact: Zhou Zhang, MD, PhD; Phone Number: (86) 25-83106666; Email: zhangzhou@smail.njm.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 45-80 years; gender is not restricted;
2. Participants must meet the diagnostic criteria for diabetes outlined in the *Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition)*, namely: patients exhibit typical symptoms of diabetes and meet one of the following conditions: 1) HbA1c ≥ 6.5%; 2) Fasting blood glucose ≥7.0 mmol/L. Fasting is defined as no caloric intake for at least 8 hours; 3) 2-hour postprandial blood glucose ≥11.1 mmol/L following an oral glucose tolerance test; 4) Random blood glucose ≥11.1 mmol/L;
3. Stable glycemic control regimen for 3 months or longer;
4. Completed a systematic neuropsychological assessment and met the MCI diagnostic criteria outlined in the 2018 American Academy of Neurology Guidelines for Mild Cognitive Impairment, satisfying the following conditions: 1) The patient or a caregiver subjectively perceives a decline in cognitive function; 2) Assessment results indicate impairment in one or more cognitive domains; 3) There is mild impairment in complex instrumental activities of daily living, but the patient maintains independence in basic activities of daily living; 4) Does not yet meet the diagnostic criteria for dementia;
5. Has an educational level of elementary school or higher and is able to cooperate in completing the assessment, VR training, and various examinations;
6. Cooperate in undergoing magnetic resonance imaging (MRI) examinations;
7. Voluntarily participates in this study, signs an informed consent form, and is able to comply with the study protocol requirements to complete follow-up.

Exclusion Criteria:

1. Suffering from other dementia-related neurological disorders (such as Alzheimer's disease, Parkinson's disease, etc.) or severe mental illness;
2. History of central nervous system disorders, including traumatic brain injury, intracranial hemorrhage, acute cerebral infarction, etc.;
3. Severe sinusitis, space-occupying lesions in the nasopharynx, or congenital disorders affecting the sense of smell,or a history of trauma;
4. Glaucoma, severe dry eye syndrome, uncorrected strabismus, severe diabetic retinopathy,or severe motion sickness, making the user unable to tolerate VR devices;
5. History of acute diabetic complications within the past 3 months (diabetic ketoacidosis, hyperglycemic hyperosmolar state, severe hypoglycemia, etc.);
6. Severe impairment of vital organ function, including cardiac, hepatic, or renal dysfunction;
7. Pregnant or breastfeeding women, or women planning to become pregnant during the study;
8. Contraindications for MRI scans, such as the presence of metallic prostheses, pacemakers, cochlear implants, or other metallic implants, or claustrophobia;
9. Participation in other clinical trials currently or within the past 3 months;
10. Known or suspected history of allergy to study-related materials;
11. Currently taking medications intended to improve cognitive function.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR-Based Cognitive Training Plus Standard Diabetes Care; Participants will receive customized virtual reality (VR)-based cognitive training in addition to standard diabetes care and weekly structured health education for 16 weeks.	Device: VR-Based Cognitive Training Plus Standard Diabetes Care; Device: Customized VR Cognitive Training System Participants will receive individualized VR cognitive training using the research team-developed system, which consists of an HTC VIVE Pro Eye head-mounted display, handheld controllers, spatial positioning base stations, and a 360° rotating seat, with software developed on the Unity3D engine. Training plans are generated based on patients' metabolic parameters (height, weight, physical activity level, diabetes duration), and difficulty is dynamically adjusted according to each session's task completion rate and response time. The training includes four core modules: (1) VR supermarket/canteen (integrating diabetes diet management); (2) multi-sensory object finding/difference detection; (3) mindfulness healing garden (multi-sensory emotional regulation); (4) comprehensive cognitive training (digit span, trail making tests). Training will be administered twice weekly for 30-60 minutes per session for 16 weeks.
Active Comparator: Traditional Paper-and-Pencil Cognitive Training Plus Standard Diabetes Care; Device: Traditional Paper-and-Pencil Cognitive Tasks Participants will complete standardized paper-and-pencil cognitive training tasks targeting the same cognitive domains as the VR group. Training will be administered twice weekly for 30-60 minutes per session for 16 weeks, with full guidance from trained research staff throughout each session to ensure standardization.	Other: Traditional Paper-and-Pencil Cognitive Training Plus Standard Diabetes Care; Device: Traditional Paper-and-Pencil Cognitive Tasks Participants will complete standardized paper-and-pencil cognitive training tasks targeting the same cognitive domains (memory, attention, executive function, processing speed) as the VR group. Training will be administered twice weekly for 30-60 minutes per session for 16 weeks, with full guidance from trained research staff throughout each session to ensure standardization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cognitive function (evaluated by MoCA score)	Whether MoCA scores in the two groups of Type 2 diabetes mellitus patients with MCI after intervention were different from those before treatment and the difference of changes between the two groups. The MoCA scale evaluates overall cognitive function, with a total score of 30. Generally, subjects scoring ≥26 points are considered as normal cognition,while between 19-25 points as mild cognitive impairment. An extra point is added If the subject has less than 12 years of education.	Baseline , Week16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chang in Immediate Memory(evaluated by RBANS score)	The immediate memory assessment primarily consists of two tests: (1) vocabulary learning and (2) story memory. The vocabulary learning task involves five rounds of serial learning to assess the ability to progressively encode verbal information; the story memory task involves the immediate retelling of a logical story to assess the ability to encode contextual information. All raw scores from the subtests must be converted to age-corrected standard scores (mean = 10, standard deviation = 3) to eliminate the influence of age on cognitive scores; the score for each cognitive domain is calculated by summing the age-corrected standard scores of its subordinate subtests and then directly converting this sum to the standard score for that cognitive domain using a conversion table (mean = 10, standard deviation = 3).	Baseline , Week16
Change in Visual-Spatial/Structural Ability(evaluated by RBANS score)	The Visual-Spatial/Structural Ability Assessment primarily consists of two tests: (1) Figure Reproduction and (2) Line Orientation. Figure Reproduction requires the subject to trace complex geometric figures, assessing visuomotor coordination and spatial structuring abilities; Line Orientation requires matching lines with identical angles, assessing the ability to judge two-dimensional spatial relationships. All raw scores from the subtests must be converted to age-corrected standard scores (mean = 10, standard deviation = 3) to eliminate the influence of age on cognitive scores; the score for each cognitive domain is calculated by summing the age-corrected standard scores of its subordinate subtests and then directly converting this sum to the standard score for that cognitive domain using a conversion table (mean = 10).	Baseline , Week16
Change in verbal function (evaluated by RBANS score)	The verbal function assessment primarily consists of two tests: (1) Picture Naming and (2) Semantic Fluency (Animal Naming). The Picture Naming test involves naming 30 pictures of common objects to assess vocabulary retrieval speed; the Semantic Fluency test involves naming as many animals as possible within one minute (a type of category fluency) to assess the activation and retrieval capabilities of the semantic network. All raw scores from the subtests must be converted to age-corrected standard scores (mean = 10, standard deviation = 3) to eliminate the influence of age on cognitive scores; the score for each cognitive domain is calculated by summing the age-corrected standard scores of its subordinate subtests and then directly converting this sum to the standard score for that cognitive domain using a conversion table (mean = 10, standard deviation = 3).	Baseline , Week16
Change in delayed memory(evaluated by RBANS score)	The delayed memory assessment primarily consists of four tests: (1) Delayed Word Recall, (2) Delayed Story Recall, (3) Delayed Picture Recall, and (4) Delayed Word Recognition. The Delayed Word Recognition task requires participants to identify 10 previously learned words from a set of 20 distractor words, thereby assessing the integrity of memory storage. The core assessment functions include the ability to store information long-term, the ability to retrieve memories, and the ability to consolidate memories; All raw scores from the subtests must be converted to age-corrected standard scores (mean = 10, standard deviation = 3) to eliminate the influence of age on cognitive scores; the score for each cognitive domain is calculated by summing the age-corrected standard scores of its subordinate subtests and then directly converting this sum to the standard score for that cognitive domain using a conversion table (mean = 10, standard deviation = 3).	Baseline , Week16
Change in attention(evaluated by RBANS score)	The attention assessment primarily consists of two tests: (1) Digit Span (including forward and backward subtests) and (2) Digit Coding. Digit Coding requires participants to pair numbers with symbols one-to-one within 90 seconds, assessing visual information processing speed and visuomotor coordination. The core assessment functions include immediate auditory memory span, auditory working memory, visual information processing speed, and visuomotor coordination; All raw scores from the subtests must be converted to age-corrected standard scores (mean = 10, standard deviation = 3) to eliminate the influence of age on cognitive scores; the score for each cognitive domain is calculated by summing the age-corrected standard scores of its subordinate subtests and then directly converting this sum to the standard score for that cognitive domain using a conversion table (mean = 10, standard deviation = 3).	Baseline , Week16
Change in Overall Cognitive Function(evaluated by RBANS score)	The RBANS Overall Cognitive Function score is calculated by summing the standard scores from the five cognitive domains described above; The core assessment focuses on the subject's overall cognitive functioning level and the severity of cognitive impairment. After summing the standard scores from the five cognitive domains, the total is directly converted using a look-up table to a Total Scale Score (TSS; mean = 100, standard deviation = 15). This scoring system aligns with internationally accepted IQ scoring systems and provides an intuitive reflection of the subject's overall cognitive status.	Baseline , Week16
Change in Resting-State Functional MRI	Assessment of baseline brain functional state. Key metrics: amplitude of low-frequency fluctuations (ALFF), regional coherence (ReHo), and functional connectivity within the default mode network and executive control network. Data are corrected for head motion and physiological noise, and data with excessive head motion (translation > 2 mm / rotation > 2°) are excluded.	Baseline , Week16
Change in Olfactory Task-Based Functional MRI	Assess the function of the olfactory-cognitive pathway. Key metrics: activation intensity in the piriform cortex, hippocampus, and orbitofrontal cortex under gradient-concentration odor stimulation; functional connectivity of the olfactory network. Analysis using a GLM model; multiple comparisons corrected using the GRF method (voxel P < 0.001, cluster P < 0.05).	Baseline , Week16
Change of Olfactory function	Whether the scores of olfactory threshold, identification and memory of the two groups after intervention were higherthan those before treatment and the difference of changes between the two groups. Olfactory testing was performed using Olfactory Function Assessment by Computerized Testing (OLFACT) (Osmic Enterprises, Inc.). Based on the University of Pennsylvania Smell Identification Test (UPSIT), OLFACT tests were computerized, standardized, and self-administered. Higher scores indicated better ability to detect odors. Threshold testing was performed by a series of binary dilutions of n- butanol solution in light mineral oil, and scores ranged from 1 to 14. Identification and memory tests included two tasks: task A with 10 different odors, and task B with 20 odors (with 10 same odors in the task A). Each participant was asked to identify each odor from four pictures in tasks A and B and to indicate whether each was old or new in task B. There was a 10-min break in-between.	Baseline , Week16
Change in blood glucose	Change in fasting blood glucose from baseline to Week 16 will be assessed using laboratory testing.	Baseline, Week 4, Week 8, Week 12, Week 16
Change in Glycated Hemoglobin	Change in glycated hemoglobin (HbA1c) from baseline to Week 16 will be assessed using laboratory testing.	Baseline, Week 16
Change in liver function	Change in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) from baseline to Week 16 will be assessed using laboratory testing.	Baseline, Week 16
Change in kidney function	Change in Serum Creatinine(Ucr),Urea,Uric Acid(UA),Glomerular Filtration Rate (eGFR) from baseline to Week 16 will be assessed using laboratory testing.	Baseline, Week 16
Change in blood lipid levels	Change in high-density lipoprotein cholesterol (HDL-C) , low-density lipoprotein cholesterol (LDL-C), Total cholesterol(TC), triglyceridesfrom(TC) from baseline to Week 16 will be assessed using laboratory testing.	Baseline, Week 16
Change in insulin and C-peptide levels at fasting and 120 minutes after a meal	Change in insulin and C-peptide levels at fasting and 120 minutes after a meal from baseline to Week 16 will be assessed using laboratory testing.	Baseline, Week 16
Percent Change in Body Weight From Baseline	Percent change in body weight from baseline to Week 4, Week 8, Week 12 and Week 16 will be compared between two groups .	Baseline, Week 4, Week 8, Week 12, Week 16
Change in waist and hip measurements	Change in waist and hip measurements from baseline to Week 4, Week 8, Week 12 and Week 16 will be assessed using standardized anthropometric measurement.	Baseline, Week 4, Week 8, Week 12, Week 16
Change in Body Composition and Fat Distribution	Changes in body composition and fat distribution will be assessed by body fat percentage using anthropometric measurements and body composition analysis.	Baseline, Week 16
Change in Controlled Attenuation Parameter	Change in controlled attenuation parameter (CAP) from baseline to Week 16 will be assessed using transient elastography.	Baseline, Week 16
Change in Liver Stiffness Measurement	Change in liver stiffness measurement (LSM) from baseline to Week 16 will be assessed using transient elastography.	Baseline, Week 16
Change in Hospital Anxiety and Depression Scale (HADS) Score	The Hospital Anxiety and Depression Scale (HADS) primarily consists of two subscales with a total of 14 items: (1) the Anxiety Subscale (HADS-A, 7 items); (2) Depression Subscale (HADS-D, 7 items); Its core function is to screen for and quantify the severity of anxiety and depressive states in non-psychiatric patients, effectively distinguishing between symptoms of physical illness and those of mood disorders; All items are scored on a 4-point scale ranging from 0 to 3. The total score for each subscale ranges from 0 to 21, and the total scale score is the sum of the two subscales (0-42). Higher scores indicate more severe anxiety or depressive symptoms. Clinical cutoffs: 0-7 points is normal, 8-10 points indicates a suspected mood disorder, and 11-21 points indicates a definite mood disorder.	Baseline , Week16
Change in Self-Rating Anxiety Scale (SAS) Score	The Self-Rating Anxiety Scale (SAS) primarily consists of 20 items covering subjective feelings of anxiety, physical symptoms, restlessness, and autonomic dysfunction; its core function is to assess the severity of participants' subjective anxiety symptoms and their dynamic changes before and after intervention; All items are rated on a 4-point scale from 1 to 4 (with 5 items reverse-scored). Raw scores are multiplied by 1.25 and rounded to the nearest whole number to obtain a standard score, with a range of 25-100 points; a higher score indicates more severe anxiety symptoms; Clinical cutoff scores: <50 points is normal, 50-59 points is mild anxiety, 60-69 points is moderate anxiety, and ≥70 points is severe anxiety.	Baseline , Week16
Change in Functional Activities Questionnaire-9 (FAQ-9) Score	The Functional Activities Questionnaire-9 (FAQ-9) primarily assesses nine items related to instrumental activities of daily living: using the telephone, shopping, meal preparation, housework, laundry, using public transportation, taking medication regularly, managing finances, and going out alone; The core assessment function is the subject's instrumental activities of daily living (IADL) ability, making it a sensitive tool for distinguishing between normal aging and functional impairment caused by mild cognitive impairment; All items are scored on a 4-point scale ranging from 0 to 3 (0 = completely independent; 3 = completely dependent on others), with a total score ranging from 0 to 27; a higher score indicates more severe impairment in instrumental activities of daily living; the clinical cutoff is ≥5, indicating significant functional impairment.	Baseline , Week16
Change in Pittsburgh Sleep Quality Index (PSQI) Score	The Pittsburgh Sleep Quality Index (PSQI) primarily assesses seven core components: subjective sleep quality, time to fall asleep, total sleep time, sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction. Its core function is to provide a comprehensive evaluation of overall sleep quality and various sleep-related issues over the past month. Each component is scored on a scale of 0-3, with a total score ranging from 0 to 21. A higher score indicates poorer sleep quality; the clinical cutoff is ≥7, indicating the presence of a clinically significant sleep disorder.	Baseline , Week16
Change in Diabetes Self-Care Activities (SDSCA) Score	The Summary of Diabetes Self-Care Activities (SDSCA) assessment primarily consists of 11 items across 6 dimensions: general diet, healthy eating, regular exercise, blood glucose monitoring, foot care, and medication adherence. Its core assessment function is to measure the frequency with which people with diabetes have performed various self-management behaviors over the past 7 days; All items are scored on a 0-7 scale (representing the number of days the behavior was performed over the past 7 days). The score for each dimension is calculated as the mean of the corresponding items, and the total score is the mean of all items, with a score range of 0-7. A higher score indicates better adherence to diabetes self-management behaviors.	Baseline , Week16

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Simulator Sickness Questionnaire (SSQ)	Assesses the severity of VR-related motion sickness, comprising 16 items related to physical discomfort (headache, dizziness, nausea, etc.). It uses a 4-point rating scale from 0 to 3 (0 = no symptoms, 3 = severe), with a total score ranging from 0 to 48. Cutoff scores: <5 points = no discomfort; 5-12 points = mild; 13-24 points = moderate (requires pause for adjustment); ≥25 points = severe (terminate intervention).	Baseline , Week 4, Week 8 , Week 12 , Week16
Change in VR Experience Acceptance Scale	Based on the Technology Acceptance Model, this scale comprises 15 items across 5 dimensions: perceived usefulness, perceived ease of use, perceived enjoyment, user experience, and intention to use. A 5-point Likert scale is used (1 = strongly disagree, 5 = strongly agree). Dimensional and total scores are calculated as the mean of the corresponding items; higher scores indicate better acceptance.	Baseline, Week 4, Week 8, Week 12, Week 16

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Estimated): June 20, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Cognition; Functional MRI; Cognitive training; Virtual reality (VR) technology
• Additional Relevant MeSH Terms: Endocrine System Diseases; Mental Disorders; Metabolic Diseases; Neurocognitive Disorders; Glucose Metabolism Disorders; Diabetes Mellitus; Cognition Disorders; Nutritional and Metabolic Diseases; Cognitive Dysfunction; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2026-0608-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No