NCT07087496

Brief Summary

The goal of this study to determine the effectiveness of insulin administration with augmented reality on increasing the knowledge and skills of patients newly diagnosed with type 2 diabetes on insulin administrations, determining patients' satisfaction with education and comparing the following two strategies: education with the Mobile Augmented Reality and education with the brochure.

  • Is Mobile augmented reality application effective on the knowledge scores and insulin application skills of patients with type 2 diabetes on insulin applications?
  • Does training with a mobile augmented reality application affect patients' satisfaction with patient education?
  • Other patients with type 2 diabetes were given insulin administration training with a brochure prepared by the researcher. All patients who participated in the study were evaluated for insulin administration knowledge and skills after the training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 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

November 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

1.2 years

First QC Date

July 4, 2025

Last Update Submit

July 18, 2025

Conditions

Keywords

diabete type 2Augmented RealityPatient EducationSubcutaneous injection

Outcome Measures

Primary Outcomes (2)

  • Insulin administration knowledge Test

    The test prepared by the researcher consists of 10 questions aimed at measuring the insulin administration knowledge levels of patients with type 2 diabetes. The content validity rate (CVR) for each question and the content validity index including all the questions were determined as 0.96. In the 10-question knowledge test, the higher the number of correct answers, the higher the score. It is assumed that the higher the score, the higher the level of knowledge about the subject. The minimum score is 1 and the maximum score is 10.It was aimed to evaluate the insulin application knowledge of patients diagnosed with type 2 diabetes who received training with mobile augmented reality and brochure after the training compared to before the training. It was expected that the mean knowledge scores of patients with Type 2 diabetes who received insulin administration training with mobile augmented reality would be higher than those who received training with brochures.

    from pre-training to immediate post-training

  • Insulin administration skills checklist

    The 24-item checklist was developed by the researcher through the literature review to assess the patient's insulin administration skills.The checklist took its final form after expert opinions were obtained from nurse specialists using the Davis technique (1992). In the checklist, each correct step was scored as 2 points, each semi-completed step was scored as 1 point, and each step not completed at all was scored as 0 zero points. It was aimed to evaluate the insulin administration skills of patients with type 2 diabetes who received training with mobile augmented reality and brochure. It was expected that the mean skill scores of Type 2 diabetic patients who received insulin application training with mobile augmented reality would be higher than those who received training with brochure.

    from pre-training to immediate post-training

Secondary Outcomes (1)

  • Scale for Satisfaction with Patient Education

    to immediate post-training

Study Arms (2)

The Intervention Group 1

EXPERIMENTAL

The Intervention Group 1 were given education on insulin administration with a brochure

Other: insulin administration training with brochure

Intervention Group 2

EXPERIMENTAL

Intervention Group 2 were given education with "Mobile Augmented Reality (MAR)

Other: Insulin application training with mobile augmented reality

Interventions

Intervention Group 2 (MAR group): Before the training, the participants were briefly informed about how the application would be performed, and their written consent was obtained. Before the insulin administration training was started, the MAR program was shown to them on the tablet by the researcher and the process steps containing QR codes prepared for insulin administration were provided on a blue flat surface and information was given about the use of the application, and a pre-test was administered to determine their knowledge levels on insulin administration. Then, the education application program prepared for insulin administration was opened and the patients were allowed to use it. The training application was performed 20-25 times. Then the post-test was administered to the participants immediately after the training. At the post-test, they were administered the Knowledge Test and Scale for Satisfaction with Patient Education.

Also known as: Interventation group 2
Intervention Group 2

The Intervention Group 1 (Brochure group): Before the training, the participants were informed about the study, and their written consent was obtained. Before insulin administration training, a knowledge test was given as a pre-test to determine the participants' knowledge levels on insulin administrations. After the pre-test, a 15-20 minute practical training was given using the brochure prepared for insulin administrations. Immediately after the training, the knowledge test and Scale for Satisfaction with Patient Education were administered as a post-test. After the post-test, the participants were asked to self-administer insulin. The insulin administration skills of the patients were assessed by the researcher using the Insulin Administration Skill Assessment Checklist. After the assessment, the participants were informed about their deficiencies, or incorrect performances.

The Intervention Group 1

Eligibility Criteria

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

You may qualify if:

  • Being newly diagnosed with Type 2 diabetes at Izmir Bakırçay University Çiğli Training and Research Hospital,
  • Not having received diabetes training,
  • Not knowing the insulin application,
  • Not having used augmented reality before,
  • Being 18 years of age or older,
  • Being able to use a smartphone.

You may not qualify if:

  • To be diagnosed with Type 2 diabetes at Izmir Bakırçay University Çiğli Training and Research Hospital,
  • To have received diabetes education,
  • To be familiar with insulin application, -To have used augmented reality before,-
  • To be under the age of 18
  • To be unable to use a smartphone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İzmir Bakırçay University Çiğli Education and Research Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (22)

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    PMID: 35170766BACKGROUND
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    PMID: 34051543BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Abdulkadir Gül, Master

    Izmir Bakırçay University Internal Medicine Nursing

    PRINCIPAL INVESTIGATOR
  • Hale Sezer, PhD

    Izmir Bakırçay University Faculty of Health Science

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study is a quasi-experimental study with a pre-test and post-test design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 4, 2025

First Posted

July 28, 2025

Study Start

November 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

July 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

The changes in the scores of insulin administration knowledge and skills of patients with type 2 diabetes before and after training and the satisfaction levels of patients with insulin administration training given with two different strategies will be given as a data set.

Shared Documents
ANALYTIC CODE
Time Frame
Beginning 1 year after publication of results
Access Criteria
Data in excell format will be shared with researchers who want to conduct meta-analysis using the raw data of the study.

Locations