Adapted Mindfulness Training for Diabetic Patients With Impaired Hypoglycemia Awareness

May 8, 2026 updated by: Mengyao Han, Yangzhou University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
Participants receive an 8-week interoception-integrated adapted mindfulness training program, in addition to routine treatment, examinations, nursing care, and health education.
Behavioral: Adapted Mindfulness Training
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.
Active Comparator: Control Group
Participants receive routine treatment, examinations, nursing care, and health education only, without the mindfulness training during the 8-week study period.
Behavioral: Routine Intervention
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Clark Score
Time Frame: Baseline (T0), immediately (T1), 1 (T2) and 3 months (T3) post-intervention
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
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
Baseline (T0), immediately (T1), 1 (T2) and 3 months (T3) post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Five Facet Mindfulness
Time Frame: Baseline (T0), immediately (T1), 1 (T2) and 3 months (T3) post-intervention
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
Baseline (T0), immediately (T1), 1 (T2) and 3 months (T3) post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yangzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YZUHL20250040

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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