- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07669038
Effects of Online Diabetes Self-management Education on Knowledge Retention, BMI, and HbA1c in Newly Diagnosed Adults With Type 2 Diabetes
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Koper, Slovenia
- Primary Healthcare Center Koper, Diabetes Outpatient Clinic, Koper, Slovenia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Online Diabetes Self-Management Education
|
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.
|
|
Active Comparator: Traditional Face-to-Face 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.
|
|
No Intervention: No Diabetes Self-Management Education (Control)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diabetes Knowledge Questionnaire (DKQ24) Score
Time Frame: Baseline, immediately post-intervention, and 3 months after intervention.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Mass Index (BMI)
Time Frame: Baseline and 3 months after intervention.
|
Change in body mass index (kg/m²) from baseline to follow-up.
|
Baseline and 3 months after intervention.
|
|
Glycated Hemoglobin (HbA1c)
Time Frame: Baseline and 3 months after intervention
|
Change in glycated hemoglobin (HbA1c) levels from baseline to follow-up.
|
Baseline and 3 months after intervention
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DSME-T2D-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.