Impaired Awareness of HypoglycemiaNCT07586527
Adapted Mindfulness Training for Diabetic Patients With Impaired Hypoglycemia Awareness
A study testing Adapted Mindfulness Training and Routine Intervention in people with Impaired Awareness of Hypoglycemia and Interoceptive Awareness, run by Yangzhou University.
Trial summary
The purpose of this randomized controlled trial is to evaluate the effectiveness of an 8-week interoception-integrated adapted mindfulness training program for patients with type 1 or type 2 diabetes who experience impaired awareness of hypoglycemia (IAH). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Impaired Awareness of Hypoglycemia, Interoceptive Awareness, Mindfulness-based Intervention
- What is being tested?
- Adapted Mindfulness Training and Routine Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 1 or type 2 diabetes mellitus according to the latest American Diabetes Association (ADA) Standards of Care in Diabetes;
- Receiving insulin therapy for ≥ 1 year;
- Age between 18 and 80 years (inclusive);
- Duration of diabetes ≥ 5 years;
- Gold score ≥ 4 and Clarke score ≥ 4;
- Voluntary participation and provision of signed informed consent.
Who cannot join
- Prior experience with mindfulness interventions;
- Diagnosed with cognitive impairment, psychiatric disorders, or other severe physical comorbidities;
- Current use of psychotropic medications;
- Pregnant or lactating women, or women of childbearing potential not using effective contraception.
About this study
Official title: Impact of Adapted Mindfulness Training Integrating Interoception on Diabetic Patients With Impaired Awareness of Hypoglycemia: A Randomized Controlled Trial
The purpose of this randomized controlled trial is to evaluate the effectiveness of an 8-week interoception-integrated adapted mindfulness training program for patients with type 1 or type 2 diabetes who experience impaired awareness of hypoglycemia (IAH). The study aims to determine whether this mindfulness intervention, which includes techniques such as body scanning and mindful eating, can help patients better recognize early physiological signals of low blood sugar compared to routine care. Researchers will measure changes in participants' interoceptive awareness and the severity of their IAH over a 3-month follow-up period. The ultimate goal is to provide a practical psychological approach to improve symptom perception and reduce the risk of severe hypoglycemic events in diabetic patients.
Read the detailed description
Diabetic patients are prone to hypoglycemia during insulin therapy, and repeated episodes can lead to impaired awareness of hypoglycemia (IAH), significantly increasing the incidence of severe hypoglycemia and adverse health outcomes. Recent studies indicate that altered interoceptive awareness is closely associated with an increased risk of IAH, and mindfulness interventions can effectively enhance an individual's interoceptive awareness. This study aims to explore the effects of an interoception-integrated adapted mindfulness training program on interoceptive awareness and impaired awareness of hypoglycemia in diabetic patients. This study is a two-arm, parallel-group randomized controlled trial. It plans to recruit 100 type 1 or type 2 diabetic patients with IAH who meet the eligibility criteria (e.g., Gold score ≥ 4 and Clarke score ≥ 4) from two community health centers in Yangzhou. Participants will be randomly assigned in a 1:1 ratio to either the intervention group (n=50) or the control group (n=50). The control group will receive routine treatment, examinations, nursing care, and health education. On this basis, the intervention group will receive an 8-week interoception-integrated adapted mindfulness training program, conducted once a week (1-1.5 hours per session). Based on Mindfulness-Based Stress Reduction (MBSR), the program utilizes core techniques such as body scanning, mindful eating, and mindful walking to reinforce patients' perception and awareness of early physiological signals of hypoglycemia, supplemented by daily home practices. Primary outcomes are the patients' interoceptive awareness (assessed by the MAIA-2 scale) and the severity of impaired awareness of hypoglycemia (evaluated by the Clarke and Gold questionnaires). Secondary outcomes include mindfulness levels (FFMQ) and negative cognitive processing bias (NCPBQ). Data collection time points are set at pre-intervention (T0), immediately post-intervention (T1), 1 month post-intervention (T2), and 3 months post-intervention (T3). Statistical analyses will employ descriptive statistics, univariate analysis, and Generalized Estimating Equations (GEE) to evaluate the intervention effects. This study is expected to provide a practical psychological intervention to improve symptom perception in diabetic patients with IAH, thereby reducing the incidence of severe hypoglycemia and improving clinical outcomes.
- Conditions
- Impaired Awareness of Hypoglycemia, Interoceptive Awareness, Mindfulness-based Intervention
- Being tested
- Adapted Mindfulness Training, Routine Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Mindfulness TrainingBehavioural
An 8-week adapted mindfulness program, based on Mindfulness-Based Stress Reduction (MBSR), is delivered to patients with Impaired Awareness of Hypoglycemia (IAH) by a multidisciplinary team. It involves weekly 1-1.5 hour face-to-face group sessions (8-10 participants) and daily home practices supervised via a WeChat group. Tailored to IAH, the curriculum integrates core skills (mindful meditation, yoga, breathing, and walking) with IAH-specific elements. By training self-awareness, attentional control, and emotional regulation, it aims to enhance interoceptive awareness. This strengthens hypoglycemia-related perceptual behaviors, helping patients acquire self-regulation skills, attend to physical sensations of hypoglycemia, perceive nocturnal hypoglycemia, and identify fear of hypoglycemia.
Routine InterventionBehavioural
The control group receives routine medical care, examinations, nursing, and health education. While they undergo the same follow-up schedule as the intervention group, no mindfulness practice guidance is provided during the study period. Upon the conclusion of the study, mindfulness-related materials will be distributed to these participants.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants receive an 8-week interoception-integrated adapted mindfulness training program, in addition to routine treatment, examinations, nursing care, and health education. Receives: Behavioral: Adapted Mindfulness Training |
| Control Group | Active comparator | Participants receive routine treatment, examinations, nursing care, and health education only, without the mindfulness training during the 8-week study period. Receives: Behavioral: Routine Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clark Score
Measured: Baseline (T0), immediately (T1), 1 (T2) and 3 months (T3) post-intervention
Gold Score
Measured: Baseline (T0), immediately (T1), 1 (T2) and 3 months (T3) post-intervention
Multidimensional Assessment of Interoceptive Awareness Version 2
Measured: Baseline (T0), immediately (T1), 1 (T2) and 3 months (T3) post-intervention
Secondary outcomes (2)
Five Facet Mindfulness
Measured: Baseline (T0), immediately (T1), 1 (T2) and 3 months (T3) post-intervention
Negative Cognitive Processing Bias Questionnaire
Measured: Baseline (T0), immediately (T1), 1 (T2) and 3 months (T3) post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Awareness of HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yangzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mengyao Han, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586527
- Sponsor's protocol ID
- YZUHL20250040
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adapted Mindfulness Training Integrating Interoception on Diabetic Patients With Impaired Awareness of Hypoglycemia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07586527
- Acronym / sponsor ID
- YZUHL20250040
- Conditions
- Impaired Awareness of Hypoglycemia, Interoceptive Awareness, Mindfulness-based Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yangzhou UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this randomized controlled trial is to evaluate the effectiveness of an 8-week interoception-integrated adapted mindfulness training program for patients with type 1 or type 2 diabetes who experience impaired awareness of hypoglycemia (IAH). The study aims to determine whether this mindfulness intervention, which includes techniques such as body scanning and mindful eating, can help patients better recognize early physiological signals of low blood sugar compared to routine care. Researchers will measure changes in participants' interoceptive awareness and the severity of their IAH over a 3-month follow-up period. The ultimate goal is to provide a practical psychological approach to improve symptom perception and reduce the risk of severe hypoglycemic events in diabetic patients.
Detailed description
Diabetic patients are prone to hypoglycemia during insulin therapy, and repeated episodes can lead to impaired awareness of hypoglycemia (IAH), significantly increasing the incidence of severe hypoglycemia and adverse health outcomes. Recent studies indicate that altered interoceptive awareness is closely associated with an increased risk of IAH, and mindfulness interventions can effectively enhance an individual's interoceptive awareness. This study aims to explore the effects of an interoception-integrated adapted mindfulness training program on interoceptive awareness and impaired awareness of hypoglycemia in diabetic patients. This study is a two-arm, parallel-group randomized controlled trial. It plans to recruit 100 type 1 or type 2 diabetic patients with IAH who meet the eligibility criteria (e.g., Gold score ≥ 4 and Clarke score ≥ 4) from two community health centers in Yangzhou. Participants will be randomly assigned in a 1:1 ratio to either the intervention group (n=50) or the control group (n=50). The control group will receive routine treatment, examinations, nursing care, and health education. On this basis, the intervention group will receive an 8-week interoception-integrated adapted mindfulness training program, conducted once a week (1-1.5 hours per session). Based on Mindfulness-Based Stress Reduction (MBSR), the program utilizes core techniques such as body scanning, mindful eating, and mindful walking to reinforce patients' perception and awareness of early physiological signals of hypoglycemia, supplemented by daily home practices. Primary outcomes are the patients' interoceptive awareness (assessed by the MAIA-2 scale) and the severity of impaired awareness of hypoglycemia (evaluated by the Clarke and Gold questionnaires). Secondary outcomes include mindfulness levels (FFMQ) and negative cognitive processing bias (NCPBQ). Data collection time points are set at pre-intervention (T0), immediately post-intervention (T1), 1 month post-intervention (T2), and 3 months post-intervention (T3). Statistical analyses will employ descriptive statistics, univariate analysis, and Generalized Estimating Equations (GEE) to evaluate the intervention effects. This study is expected to provide a practical psychological intervention to improve symptom perception in diabetic patients with IAH, thereby reducing the incidence of severe hypoglycemia and improving clinical outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Adapted Mindfulness TrainingParticipants receive an 8-week interoception-integrated adapted mindfulness training program, in addition to routine treatment, examinations, nursing care, and health education. |
| Control Group | Active comparator | Behavioral: Routine InterventionParticipants receive routine treatment, examinations, nursing care, and health education only, without the mindfulness training during the 8-week study period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with type 1 or type 2 diabetes mellitus according to the latest American Diabetes Association (ADA) Standards of Care in Diabetes;
- Receiving insulin therapy for ≥ 1 year;
- Age between 18 and 80 years (inclusive);
- Duration of diabetes ≥ 5 years;
- Gold score ≥ 4 and Clarke score ≥ 4;
Key exclusion criteria (4 listed)
- Prior experience with mindfulness interventions;
- Diagnosed with cognitive impairment, psychiatric disorders, or other severe physical comorbidities;
- Current use of psychotropic medications;
- Pregnant or lactating women, or women of childbearing potential not using effective contraception.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Mindfulness TrainingAn 8-week adapted mindfulness program, based on Mindfulness-Based Stress Reduction (MBSR), is delivered to patients with Impaired Awareness of Hypoglycemia (IAH) by a multidisciplinary team. It involves weekly 1-1.5 hour face-to-face group sessions (8-10 participants) and daily home practices supervised via a WeChat group. Tailored to IAH, the curriculum integrates core skills (mindful meditation, yoga, breathing, and walking) with IAH-specific elements. By training self-awareness, attentional control, and emotional regulation, it aims to enhance interoceptive awareness. This strengthens hypoglycemia-related perceptual behaviors, helping patients acquire self-regulation skills, attend to physical sensations of hypoglycemia, perceive nocturnal hypoglycemia, and identify fear of hypoglycemia. | Behavioural | Intervention Group |
| Routine InterventionThe control group receives routine medical care, examinations, nursing, and health education. While they undergo the same follow-up schedule as the intervention group, no mindfulness practice guidance is provided during the study period. Upon the conclusion of the study, mindfulness-related materials will be distributed to these participants. | Behavioural | Control Group |
Primary outcome
Clark Score
Time frame: Baseline (T0), immediately (T1), 1 (T2) and 3 months (T3) post-intervention
Gold Score
Time frame: Baseline (T0), immediately (T1), 1 (T2) and 3 months (T3) post-intervention
Multidimensional Assessment of Interoceptive Awareness Version 2
Time frame: Baseline (T0), immediately (T1), 1 (T2) and 3 months (T3) post-intervention
2 secondary outcomes
Five Facet Mindfulness
Time frame: Baseline (T0), immediately (T1), 1 (T2) and 3 months (T3) post-intervention
Negative Cognitive Processing Bias Questionnaire
Time frame: Baseline (T0), immediately (T1), 1 (T2) and 3 months (T3) post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Mindfulness Training and Routine Intervention in people with Impaired Awareness of Hypoglycemia and Interoceptive Awareness, run by Yangzhou University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clark Score (time frame: Baseline (T0), immediately (T1), 1 (T2) and 3 months (T3) post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.