RecruitingNot Applicable

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

China40 participantsStarted 2026-06-01

Plain-language summary

A single-center, prospective, open-label, parallel-group randomized controlled trial is conducted 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 are randomly assigned 1:1 to either the intervention group (16 weeks of individualized VR training with dynamic difficulty, 2 sessions/week, 30-60 minutes/session) or the active control group (standardized paper-and-pencil cognitive tasks). All participants 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 are also systematically monitored.

Who can participate

Age range

45 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Aged 45-80 years; gender is not restricted;
. 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;
. Stable glycemic control regimen for 3 months or longer;
. 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial uses virtual reality-based cognitive training specifically for people with both Type 2 diabetes and mild cognitive impairment — does my current combination of these two conditions make this worth discussing as an option for me?
2The trial measures changes in cognitive function using something called the MoCA score — can you explain what that test involves and what a meaningful improvement would actually look like in day-to-day life for someone in my situation?
3Since this trial is listed as Phase NA, which often means it's a behavioral or device-based study rather than a drug trial, what is currently known about the safety and any potential downsides of VR-based cognitive training for someone with my health profile?
4Before considering something like this trial, are there standard-of-care approaches for managing mild cognitive impairment in people with Type 2 diabetes that I should try first, or would this kind of training be something I could pursue alongside my existing treatment?
5How demanding is participating in a VR-based training program likely to be in terms of time, technology comfort, and travel or clinic visits, and is that realistic given everything else I'm managing with my diabetes care?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in cognitive function (evaluated by MoCA score)

Timeframe: Baseline , Week16

Trial details

NCT IDNCT07650318

SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-30

Contact for this trial

Yan Bi, MD, PhD

6-25-83-105302 biyan@nju.edu.cn

View on ClinicalTrials.gov More Type 2 Diabetes Mellitus (T2DM) trials

Plain-language summary

Who can participate

Age range

45 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Aged 45-80 years; gender is not restricted;
. 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;
. Stable glycemic control regimen for 3 months or longer;
. 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;

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria