Adapted Mindfulness Training for Diabetic Patients With Impaired Hypoglycemia Awareness

ConditionsImpaired Awareness of Hypoglycemia Interoceptive Awareness Mindfulness-based Intervention

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorYangzhou University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Adapted Mindfulness Training
Behavioral
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 Intervention
Behavioral
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.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Intervention GroupExperimental treatment 1 intervention

Group B: Control GroupActive comparator 1 intervention