NCT07669038

Brief Summary

Type 2 diabetes requires active self-management from the time of diagnosis, but participation in traditional face-to-face diabetes self-management education is often limited by access-related and personal barriers. Online education may provide a more flexible and accessible way to deliver structured diabetes education, particularly for newly diagnosed adults who need timely support in understanding and managing their condition. This study evaluated the effects of online diabetes self-management education compared with traditional face-to-face education on diabetes knowledge retention, body mass index (BMI), and HbA1c in adults newly diagnosed with type 2 diabetes who were not receiving antidiabetic medication. A total of 123 participants were included: 49 participants received online diabetes self-management education, 52 participants received traditional face-to-face education, and 22 participants who declined education formed a non-randomized control group. Diabetes knowledge was assessed at baseline, immediately after the intervention, and at three-month follow-up, while BMI and HbA1c were measured at baseline and follow-up. At three-month follow-up, both online and traditional education groups showed significantly greater diabetes knowledge compared with the control group. The online education group also showed better immediate post-intervention knowledge than the traditional education group. Both education groups had significant reductions in BMI from baseline to follow-up, while no significant short-term effect on HbA1c was observed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2024

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
Last Updated

July 8, 2026

Status Verified

July 1, 2026

Enrollment Period

1.3 years

First QC Date

June 19, 2026

Last Update Submit

July 6, 2026

Conditions

Keywords

type 2 diabetes mellituseducationtelemedicineglycaemic control

Outcome Measures

Primary Outcomes (1)

  • Diabetes Knowledge Questionnaire (DKQ24) Score

    Change in diabetes-related knowledge measured using the 24-item Diabetes Knowledge Questionnaire (DKQ24). Scores range from 0 to 24, with higher scores indicating greater diabetes knowledge.

    Baseline, immediately post-intervention, and 3 months after intervention.

Secondary Outcomes (2)

  • Body Mass Index (BMI)

    Baseline and 3 months after intervention.

  • Glycated Hemoglobin (HbA1c)

    Baseline and 3 months after intervention

Study Arms (3)

Online Diabetes Self-Management Education

EXPERIMENTAL
Behavioral: Online Diabetes Self-Management Education

Traditional Face-to-Face Diabetes Self-Management Education

ACTIVE COMPARATOR
Behavioral: Traditional Face-to-Face Diabetes Self-Management Education

No Diabetes Self-Management Education (Control)

NO INTERVENTION

Interventions

Participants attended a 60-minute interactive online diabetes self-management education program delivered through a Moodle learning platform using H5P interactive content. The program consisted of five modules: Diabetes Treatment and Management, Recommendations for Healthy Eating with Diabetes, Physical Activity Recommendations, Diabetes Complications and Diabetic Foot, and Planning Lifestyle Modifications. The intervention was designed to improve diabetes-related knowledge and support self-management among adults newly diagnosed with type 2 diabetes.

Online Diabetes Self-Management Education

Participants attended a 60-minute face-to-face diabetes self-management education session conducted in small groups of 4-6 participants. The educational content covered diabetes treatment and management, healthy eating recommendations, physical activity recommendations, diabetes complications and diabetic foot care, and planning lifestyle modifications. The intervention was designed to improve diabetes-related knowledge and support self-management among adults newly diagnosed with type 2 diabetes.

Traditional Face-to-Face Diabetes Self-Management Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years or older.
  • Diagnosis of type 2 diabetes mellitus within the previous 1 month.
  • Ability to access and use information and communication technology devices (smartphone, computer, or tablet).
  • Proficiency in the language used for the educational intervention.
  • Ability and willingness to provide written informed consent.

You may not qualify if:

  • Pregnancy.
  • Current treatment of type 2 diabetes mellitus with antidiabetic medication (oral agents, injectable medications, or insulin).
  • Previous participation in a diabetes self-management education program.
  • Presence of concomitant diseases or treatments that could affect blood glucose levels (e.g., cancer or corticosteroid treatment).
  • Visual impairment, cognitive impairment, literacy difficulties, or manual dexterity limitations that could interfere with participation.
  • Deterioration in health status or occurrence of events that, in the opinion of the investigators, warranted discontinuation from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary Healthcare Center Koper, Diabetes Outpatient Clinic, Koper, Slovenia

Koper, Slovenia

Location

Related Publications (2)

  • Garcia AA, Villagomez ET, Brown SA, Kouzekanani K, Hanis CL. The Starr County Diabetes Education Study: development of the Spanish-language diabetes knowledge questionnaire. Diabetes Care. 2001 Jan;24(1):16-21. doi: 10.2337/diacare.24.1.16.

    PMID: 11194219BACKGROUND
  • CENČIČ, Ajda, 2025. The Effect of a Web-Based Educational Program for Individuals With Type 2 Diabetes [In Slovenian: Učinek spletnega edukacijskega programa za osebe s sladkorno boleznijo tipa 2]: Doctoral dissertation [online]. Izola: A. Cenčič. [Accessed 19 June 2026]. Available at: https://repozitorij.upr.si/IzpisGradiva.php?lang=slv&id=22637

    RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2026

First Posted

June 25, 2026

Study Start

March 14, 2023

Primary Completion

June 26, 2024

Study Completion

June 26, 2024

Last Updated

July 8, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

Anonymized individual participant data that underlie the results reported in this study will be shared if required by the journal in which the study is published. Available data include demographic characteristics, Diabetes Knowledge Questionnaire (DKQ24) scores, body mass index (BMI), and glycated hemoglobin (HbA1c) measurements collected during the study.

Time Frame
Data will be available following publication of the study.
Access Criteria
Data may be provided to qualified researchers upon reasonable request and in accordance with journal, ethical, and institutional data-sharing requirements.

Locations