Type 2 Diabetes Treated With InsulinNCT06060743
Examining the Effect of Mobile Application on Insulin Use Perception and Self-Management
A study testing INS-MOBILE: Mobile Application Developed for Insulin Use in people with Type 2 Diabetes Treated With Insulin, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The main purpose of the research is; To develop a mobile application for individuals with Type 2 diabetes who use insulin and to examine the effect of the developed mobile application on the perception and self-management of insulin use. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Treated With Insulin
- What is being tested?
- INS-MOBILE: Mobile Application Developed for Insulin Use
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 May 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and over,
- Aware and communicative,
- Those diagnosed with Type 2 DM and using insulin for the first time
- Able to administer insulin on his own,
- Able to use Android based phone,
- Having a digital literacy scale score above 17,
- Agreeing to participate in the research
Who cannot join
- Under 18 years of age,
- Having vision problems,
- Do not have an Android phone,
- Unconscious and unable to communicate,
- Not having sufficient motor skills,
- Those who did not agree to participate in the research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Effect of the Mobile Application Developed for Individuals With Type 2 Diabetes Using Insulin on the Perception of Insulin Use and Self-Management
The main purpose of the research is; To develop a mobile application for individuals with Type 2 diabetes who use insulin and to examine the effect of the developed mobile application on the perception and self-management of insulin use.
Read the detailed description
In recent years, an increase in insulin use has been observed in individuals with Type 2 DM. Since any mistake in insulin use can lead to hyperglycemic crisis or severe hypoglycemia, correct administration of insulin forms the basis of successful diabetes management. Errors related to insulin therapy are defined as important and correctable medication errors. Such errors related to insulin therapy can potentially occur at every step of diabetes management.
It is stated that interventions that can provide effective self-management and behavioral change can be planned by evaluating individuals' perceptions of the disease and treatment in diabetes management. In our country, only one thesis study evaluating the effect of video-supported teaching given to type 2 diabetic patients on insulin self-management and application skills has been found. This study found that video-assisted instruction given to patients with Type 2 diabetes increased their ability to administer insulin injections and their self-management. In the thesis study in question, the video was shot by the researcher using a model, and individuals who had been using insulin for at least one year were included in the study. In this project, a mobile application for insulin use will be developed and this application will include three separate videos, two of which are animation videos, and a game for insulin use. Our study will be conducted on individuals who will use insulin for the first time, and no study has been found in our country with this sample and population.
When global goals for sustainable development are examined, it is aimed to "promote mental health and well-being by reducing premature deaths from non-communicable diseases by one third through prevention and treatment by 2030". The development of technology and its availability in every aspect of life has also affected patient care, and technological devices and mobile applications have been integrated into patient care. Studies show that the mobile applications used are effective in managing the disease and maintaining self-care activities in individuals with Type 2 DM. In chronic disease management, both compliance with treatment and self-management can be made permanent with mobile applications developed specifically for the disease.
In the research, the educational material was created with an animated video, and the created video was transferred to the mobile application. Thus, the patient will be able to access the educational content via the mobile application at any time and experience the insulin administration steps countless times on the mobile application. By giving feedback from the application regarding the mistakes made during the application, the user will be able to see at what point he made a mistake. Audiovisual materials used in patient education positively affect learning because they appeal to more than one sensory organ. Utilizing technology and using visual and auditory stimuli in patient education will strengthen learning, and the skills aimed to be acquired with the educational material will become more permanent.
- Conditions
- Type 2 Diabetes Treated With Insulin
- Being tested
- INS-MOBILE: Mobile Application Developed for Insulin Use
- Keywords
- type 2 diabetes mellitus, mobile application, Self-Management
- 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.
INS-MOBILE: Mobile Application Developed for Insulin UseOther
After determining the application and control groups in the research, the purpose of the research was explained to both groups. Participants were informed that the application would last 1 month. It was explained that data collection forms would be filled out before the application (Z0), on the 14th day of the application (Z1), and on the 28th day of the application (Z2). On the 0th and 28th days of the follow-up, the participants' insulin administration skills were evaluated face-to-face by the researcher using the Insulin Therapy Skill Observation Form. In addition to the standard training given by diabetes training nurses, a mobile application on insulin use was sent to the application group, while the control group was given standard training only by diabetes training nurses.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Data collection tools were applied to individuals in the control group on day 0 (Z0), day 14 (Z1) and day 28 (Z2) of follow-up. Data collection tools applied to the control group are as follows: Patient Introduction Form, Insulin Treatment Appraisal Scale,, Insulin Therapy Self-Management Scale, Insulin Information Form, Insulin Injection Skill Observation Form and Metabolic Control Variables Form. |
| application group | Experimental | Individuals in the application group will be given individual training on how to use the application through the application demo. Data collection forms will be applied to individuals in the application group on day 0 (Z0), day 14 (Z1) and day 28 (Z2). The forms to be used are: Patient Introduction Form, Insulin Treatment Appraisal Scale, Insulin Therapy Self-Management Scale, Insulin Information Form, Metabolic Control Variables Form, Insulin Injection Skill Observation Form and Digital Literacy Scale. Receives: Other: INS-MOBILE: Mobile Application Developed for Insulin Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin information sheet
This form, created by the researchers after literature review, consists of 25 questions. This form includes questions about general information about insulins, insulin storage conditions, injection preparation stages, injection sites and injection technique. The form is answered as True/False. The questions in the form were evaluated out of 100 points.
Measured: two weeks
Secondary outcomes (3)
Insulin Treatment Appraisal Scale
The scale consists of two subscales, positive and negative attitude, and 20 items. Scale items are rated on a Likert type scale between "strongly disagree", 1 point, and "strongly agree", 5 points.
Measured: two weeks
Insulin Therapy Self-Management Scale
The scale consists of 32 items with a three-factor structure, scored using a five-point Likert-type scale.
Measured: two weeks
Insulin Injection Skill Observation Form
It consists of 21 items including the stages of insulin injection.
Measured: Evaluated at first and last follow-up/ four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Jan 2024
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Treated With InsulinStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It consists of two groups, application and control, and three follow-ups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Nedime Hazal Döner, Ege University
- Investigators
- Nedime Hazal Doner, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060743
- Sponsor's protocol ID
- EU-NF-NHD-01
- Status last verified
- Sep 2023
- First submitted
- 25 Sep 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Doner NH, Yesilbalkan OU, Cetinkalp S. Effects of a Mobile Application for Patients With Type 2 Diabetes Initiating Insulin Therapy: Randomized Controlled Trial. Int J Nurs Pract. 2026 Aug;32(4):e70165. doi: 10.1111/ijn.70165.
PubMed 42374657
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of the Mobile Application Developed for Individuals With Type 2 Diabetes Using Insulin on the Perception of Insulin Use and Self-Management
- ClinicalTrials.gov ID
- NCT06060743
- Acronym / sponsor ID
- EU-NF-NHD-01
- Conditions
- Type 2 Diabetes Treated With Insulin
- Keywords
- type 2 diabetes mellitus, mobile application, Self-Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of the research is; To develop a mobile application for individuals with Type 2 diabetes who use insulin and to examine the effect of the developed mobile application on the perception and self-management of insulin use.
Detailed description
In recent years, an increase in insulin use has been observed in individuals with Type 2 DM. Since any mistake in insulin use can lead to hyperglycemic crisis or severe hypoglycemia, correct administration of insulin forms the basis of successful diabetes management. Errors related to insulin therapy are defined as important and correctable medication errors. Such errors related to insulin therapy can potentially occur at every step of diabetes management.
It is stated that interventions that can provide effective self-management and behavioral change can be planned by evaluating individuals' perceptions of the disease and treatment in diabetes management. In our country, only one thesis study evaluating the effect of video-supported teaching given to type 2 diabetic patients on insulin self-management and application skills has been found. This study found that video-assisted instruction given to patients with Type 2 diabetes increased their ability to administer insulin injections and their self-management. In the thesis study in question, the video was shot by the researcher using a model, and individuals who had been using insulin for at least one year were included in the study. In this project, a mobile application for insulin use will be developed and this application will include three separate videos, two of which are animation videos, and a game for insulin use. Our study will be conducted on individuals who will use insulin for the first time, and no study has been found in our country with this sample and population.
When global goals for sustainable development are examined, it is aimed to "promote mental health and well-being by reducing premature deaths from non-communicable diseases by one third through prevention and treatment by 2030". The development of technology and its availability in every aspect of life has also affected patient care, and technological devices and mobile applications have been integrated into patient care. Studies show that the mobile applications used are effective in managing the disease and maintaining self-care activities in individuals with Type 2 DM. In chronic disease management, both compliance with treatment and self-management can be made permanent with mobile applications developed specifically for the disease.
In the research, the educational material was created with an animated video, and the created video was transferred to the mobile application. Thus, the patient will be able to access the educational content via the mobile application at any time and experience the insulin administration steps countless times on the mobile application. By giving feedback from the application regarding the mistakes made during the application, the user will be able to see at what point he made a mistake. Audiovisual materials used in patient education positively affect learning because they appeal to more than one sensory organ. Utilizing technology and using visual and auditory stimuli in patient education will strengthen learning, and the skills aimed to be acquired with the educational material will become more permanent.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- It consists of two groups, application and control, and three follow-ups.
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Data collection tools were applied to individuals in the control group on day 0 (Z0), day 14 (Z1) and day 28 (Z2) of follow-up. Data collection tools applied to the control group are as follows: Patient Introduction Form, Insulin Treatment Appraisal Scale,, Insulin Therapy Self-Management Scale, Insulin Information Form, Insulin Injection Skill Observation Form and Metabolic Control Variables Form. |
| application group | Experimental | Other: INS-MOBILE: Mobile Application Developed for Insulin UseIndividuals in the application group will be given individual training on how to use the application through the application demo. Data collection forms will be applied to individuals in the application group on day 0 (Z0), day 14 (Z1) and day 28 (Z2). The forms to be used are: Patient Introduction Form, Insulin Treatment Appraisal Scale, Insulin Therapy Self-Management Scale, Insulin Information Form, Metabolic Control Variables Form, Insulin Injection Skill Observation Form and Digital Literacy Scale. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years and over,
- Aware and communicative,
- Those diagnosed with Type 2 DM and using insulin for the first time
- Able to administer insulin on his own,
- Able to use Android based phone,
Key exclusion criteria (6 listed)
- Under 18 years of age,
- Having vision problems,
- Do not have an Android phone,
- Unconscious and unable to communicate,
- Not having sufficient motor skills,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INS-MOBILE: Mobile Application Developed for Insulin UseAfter determining the application and control groups in the research, the purpose of the research was explained to both groups. Participants were informed that the application would last 1 month. It was explained that data collection forms would be filled out before the application (Z0), on the 14th day of the application (Z1), and on the 28th day of the application (Z2). On the 0th and 28th days of the follow-up, the participants' insulin administration skills were evaluated face-to-face by the researcher using the Insulin Therapy Skill Observation Form. In addition to the standard training given by diabetes training nurses, a mobile application on insulin use was sent to the application group, while the control group was given standard training only by diabetes training nurses. | Other | application group |
Primary outcome
insulin information sheet
Time frame: two weeks
This form, created by the researchers after literature review, consists of 25 questions. This form includes questions about general information about insulins, insulin storage conditions, injection preparation stages, injection sites and injection technique. The form is answered as True/False. The questions in the form were evaluated out of 100 points.
3 secondary outcomes
Insulin Treatment Appraisal Scale
Time frame: two weeks
Insulin Therapy Self-Management Scale
Time frame: two weeks
Insulin Injection Skill Observation Form
Time frame: Evaluated at first and last follow-up/ four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Derived from this study: PubMed 42374657Doner NH, Yesilbalkan OU, Cetinkalp S. Effects of a Mobile Application for Patients With Type 2 Diabetes Initiating Insulin Therapy: Randomized Controlled Trial. Int J Nurs Pract. 2026 Aug;32(4):e70165. doi: 10.1111/ijn.70165.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes Treated With Insulin
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nedime Hazal Doner principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INS-MOBILE: Mobile Application Developed for Insulin Use in people with Type 2 Diabetes Treated With Insulin, run by Ege University at 1 site in Turkey (Türkiye).
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 7 inclusion and 6 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 6 Aug 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 Turkey (Türkiye). 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?
insulin information sheet (time frame: two weeks). 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 NCT06060743, which also lists 1 linked publication.
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 6 Aug 2026.