An interventional study of Adapted Mindfulness Training and Routine Intervention in Impaired Awareness of Hypoglycemia, Interoceptive Awareness and Mindfulness-based Intervention, sponsored by Yangzhou University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Yangzhou University · Not applicable, Interventional, and Supportive care
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.
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.
Yangzhou University is the lead sponsor of 40 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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
Participants receive routine treatment, examinations, nursing care, and health education only, without the mindfulness training during the 8-week study period.
Behavioral: Routine Intervention
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.
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.
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
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
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Yangzhou University