N/A N=50 Randomized Double-blind Supportive Care

Effects of a Health Intervention on Fear of Hypoglycemia : a Pilot Study

Type 2 Diabetes Mellitus · Fear of Hypoglycemia · Health Education · Impaired Awareness of Hypoglycemia · Self-Management

Bottom Line

View on ClinicalTrials.gov: NCT06197360 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2025

Primary outcome: Primary: Hypoglycemia Fear Behavioral — 59.60; 63.88; 57.52; 44.20 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Based on BCW Theory of Health Education (Behavioral); General diabetes health education (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Yangzhou University
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Hypoglycemia Fear Behavioral	59.60; 63.88; 57.52; 44.20; 55.16; 39.72	—
PRIMARY Hypoglycemia Fear Worry	32.72; 32.96; 29.76; 18.76; 27.16; 15.44	—
SECONDARY Gold Rating	2.84; 2.88; 2.32; 1.68; 1.84; 1.28	—
SECONDARY The Patients Assessment Chronic Illness Care( PACIC)	3.42; 3.40; 3.69; 4.45; 3.55; 4.46	—
SECONDARY The Self-management Attitude Scale for Diabetes Patients	3.91; 4.10; 4.21; 4.78; 4.28; 4.83	—

Summary

The purpose of this study was to construct a Fear of Hypoglycemia(FoH) intervention program for type 2 diabetic patients based on the Behaviour Change Wheel (BCW) theory and to investigate the feasibility, acceptability, and initial effects of the program.

Eligibility Criteria

Inclusion Criteria

Comply with the 2020 Chinese guidelines for the prevention and treatment of type 2 diabetes mellitus
Age ≥18 years
Duration of diabetes mellitus ≥1 year
FOH according to the elevated item endorsement criterion (E I criterion): ≥3 points on any item of the Hypoglycemic Fear-Worry Scale (HFS-WS)
Patients who have the ability to listen, read, write, walk, and cooperate to complete the study
Patients who have a smart phone, and can skillfully use WeChat or telephone to communicate
Voluntarily participate in this study and sign the informed consent form.

Exclusion Criteria

Patients with comorbid acute complications or other serious diseases or disorders of consciousness, such as diabetic hypertonic state, tumors, coma, etc.
Patients with comorbid psychiatric diseases or taking psychotropic drugs
Patients who have recently or are participating in other studies on similar topics

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06197360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.