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Type 2 Diabetes Mellitus (T2DM)NCT07669038

Effects of Online Diabetes Self-management Education on Knowledge Retention, BMI, and HbA1c in Newly Diagnosed Adults With Type 2 Diabetes

A study testing Online Diabetes Self-Management Education and Traditional Face-to-Face Diabetes Self-Management Education in people with Type 2 Diabetes Mellitus (T2DM) and Diabetes Self-Management Education, run by University of Primorska at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Online Diabetes Self-Management Education and Traditional Face-to-Face Diabetes Self-Management Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
1 siteSlovenia
Study dates
14 Mar 2023to 26 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • Development of any exclusion criterion during the study period.
  • Deterioration in health status or occurrence of events that, in the opinion of the investigators, warranted discontinuation from the study.

Trial locations and contacts

1 site in 1 country.

Slovenia1 site

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

    Koper

Other trials in Slovenia

About this study

Official title: Effects of Online Diabetes Self-management Education on Knowledge Retention, BMI, and HbA1c in Newly Diagnosed Adults With Type 2 Diabetes: a Quasi-experimental Study

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.

Being tested
Online Diabetes Self-Management Education, Traditional Face-to-Face Diabetes Self-Management Education
Keywords
type 2 diabetes mellitus, education, telemedicine, glycaemic control
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online Diabetes Self-Management EducationBehavioural

    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.

  • Traditional Face-to-Face Diabetes Self-Management EducationBehavioural

    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.

Study groups in NCT07669038
Study groupRoleWhat they receive
Online Diabetes Self-Management EducationExperimentalNot described
Receives: Behavioral: Online Diabetes Self-Management Education
Traditional Face-to-Face Diabetes Self-Management EducationActive comparatorNot described
Receives: Behavioral: Traditional Face-to-Face Diabetes Self-Management Education
No Diabetes Self-Management Education (Control)No interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)

  1. Body Mass Index (BMI)

    Change in body mass index (kg/m²) from baseline to follow-up.

    Measured: Baseline and 3 months after intervention.

  2. Glycated Hemoglobin (HbA1c)

    Change in glycated hemoglobin (HbA1c) levels from baseline to follow-up.

    Measured: Baseline and 3 months after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2026
  2. Study start14 Mar 2023
  3. Primary completion26 Jun 2024
  4. Study completion26 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07669038
Sponsor's protocol ID
DSME-T2D-2026
Status last verified
Jul 2026
First submitted
19 Jun 2026
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 11194219

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Online Diabetes Self-Management Education and Traditional Face-to-Face Diabetes Self-Management Education in people with Type 2 Diabetes Mellitus (T2DM) and Diabetes Self-Management Education, run by University of Primorska at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diabetes Knowledge Questionnaire (DKQ24) Score (time frame: Baseline, immediately post-intervention, and 3 months after intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07669038, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

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