NCT07316699

Brief Summary

The aim of this study is to validate the validity and reliability of the Hypoglycaemia Self-Care Behaviour Scale, developed to assess hypoglycaemia self-care behaviours in patients with type 2 diabetes, through a prospective cross-sectional study.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

December 19, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 5, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

January 31, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

December 19, 2025

Last Update Submit

May 6, 2026

Conditions

Keywords

diabetes mellitusHypoglycaemiaSelf-Care BehaviourScale

Outcome Measures

Primary Outcomes (1)

  • Hypoglycaemia Self-Care Behaviour Scale

    Developed in 2025 by Huang and colleagues. The scale consists of 10 items and 4 subscales: 'recognising hypoglycaemia and carbohydrate supplementation', 'preventing hypoglycaemia during exercise', 'carbohydrate assessment' and 'seeking medical help'. Each item is rated on a 5-point scale ranging from 1 (never) to 5 (always). The maximum possible score on the scale is 50, and scores below 30 indicate a need for hypoglycaemia education. The internal consistency of the developed scale ranges from 0.73 to 0.94, indicating strong reliability (Huang et al., 2025).

    6 months

Secondary Outcomes (1)

  • Hypoglycaemic Confidence Scale

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Type 2 diabetes patients receiving outpatient treatment under follow-up at the diabetes clinic

You may qualify if:

  • Aged 18 years or older,
  • With type 2 diabetes mellitus,
  • Who have had blood sugar levels \<70 mg/dL at least once in the last six months,
  • Who can read and write Turkish and communicate effectively.

You may not qualify if:

  • Patients diagnosed with mental and/or cognitive disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bilecik Seyh Edebali University

Bilecik, Bilecik, 11000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes MellitusHypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

December 19, 2025

First Posted

January 5, 2026

Study Start

January 31, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 11, 2026

Record last verified: 2026-05

Locations