Insulin Dependent DiabetesİNSÜLİNNCT05915338
Training on Using ıInsulin in Patients With Type 2 Diabetes
An observational study of Insulin Dependent Diabetes and Diabetes type2, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to evaluate the effect of individual insulin use training given to patients with type 2 diabetes using insulin on safe drug administration, pain level and perception of treatment. The study was conducted between October 2022 and March 2023 with a randomized control group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insulin Dependent Diabetes, Diabetes type2
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 30 Mar 2023
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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
Study population: Patients with Type 2 Diabetes
Who may be able to join
- Patients included in the study;
- 18 years and over Using insulin injections for at least six months or longer
- Meeting the American Diabetes Association (ADA, 2021) diagnostic criteria for Type 2 diabetes
- No communication and mental problems
- Insulin injection made by himself or his family The patients who agreed to participate in the study.
Who cannot join
- Patients excluded from the study;
- Self or family member health personnel Those with advanced retinopathy, nephropathy, neuropathy
- Diagnosed with type 1 diabetes
- Pregnant or breastfeeding women
- Patients who participated in another clinical trial concurrently or within 1 month prior to the start of the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Eof ıInsulin Use Education on Safe Drug Administration, Pain Level and Perception of Treatment in Patients With Type 2 Diabetes
This study was conducted to evaluate the effect of individual insulin use training given to patients with type 2 diabetes using insulin on safe drug administration, pain level and perception of treatment. The study was conducted between October 2022 and March 2023 with a randomized control group.
Read the detailed description
Objective: The aim of this study was to examine the effects of individual insulin use training given to patients with Type 2 diabetes on safe drug administration, pain level and treatment perception, and to contribute to both national and international literature.
Method: It was conducted between October 2022 and March 2023 as a randomized controlled study in a pre-test-post-test order to determine the effect of individual insulin use education given to patients with type 2 diabetes on safe drug administration, pain level and treatment perception. The data were collected by the researchers with the descriptive information form of the patients, the Insulin Administration Skill Observation Form, the Visual Analogue Scale and the Insulin Therapy Evaluation Scale.
Data Collection: Face-to-face and individual interviews with patients who applied to the Internal Diseases and Endocrinology Polyclinic and Diabetes Nursing Polyclinics of a state hospital in a city located in the Southeastern Anatolia Region of Turkey, and who were hospitalized in the Internal Diseases, Endocrinology, Physical Therapy and Rehabilitation and Cardiology Services. collected using the method. A pilot study was not conducted before starting the study. Before the study, all patients were informed about the study and their verbal and written consents were obtained.
- Conditions
- Insulin Dependent Diabetes, Diabetes type2
- Keywords
- Tip 2 Diyabet, Güvenli İlaç Kullanımı, Tedavi Algısı, İnsülin
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | -Pre-test data were obtained by using the descriptive information form, İUBGF, VAS, and HRAS. The patients were asked to self-administer a dose of insulin that day, and the ability of the patients to administer the insulin dose was recorded in the IUBGF as the 1st follow-up by the researchers. Afterwards, individual insulin use training was given and the "Educational Manual on the Use of Insulin for Individuals with Type 2 Diabetes" was given to the patients and the first follow-up was completed. -2 weeks later, post-test data were obtained from the patients using IUBGF, VAS, and HRAS. The ability of the patients to administer the insulin dose was recorded in the IUBGF as the second follow-up by the researchers. After 8 weeks, post-test data were obtained by using IUBGF, VAS, and HRAS as retention tests. The ability of the patients to administer the insulin dose was recorded by the researchers as the 3rd follow-up retention test in IUBGF. | |
| Control Group | -Pre-test data were obtained by using the descriptive information form, İUBGF, VAS, and HRAS. The patients were asked to self-administer a dose of insulin that day, and the ability of the patients to administer the insulin dose was recorded in the IUBGF as the 1st follow-up by the researchers. -2 weeks later, post-test data were obtained from the patients using IUBGF, VAS, and HRAS. Patients were asked to self-administer a daily dose of insulin. The ability of the patients to administer the insulin dose was recorded in the IUBGF as the second follow-up by the researchers. After 8 weeks, post-test data were obtained by using IUBGF, VAS, and HRAS as retention tests. Patients were asked to self-administer a daily dose of insulin. The ability of the patients to administer the insulin dose was recorded in IUBGF as the 3rd follow-up retention test by the researchers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fırst follow - up survey
Pretest data was obtained using the introductory information form, IASOF, VAS, and ITES.
Patients were requested to apply their daily dose of insulin to themselves and patients' application skills were recorded by the researchers into IASOF as the 1st observation.
Measured: Fırst test-fırst applıcatıon both groups at the begınnıng of the research
Secondary outcomes (1)
Last test survey
Posttest data was obtained through the use of IASOF, VAS, and ITES. Patients were requested to apply their insulin dose of the day to themselves. Patients' insulin application skills were recorded by researchers into IASOF as the 2nd observation.
Measured: 2 weeks after the fırst watch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Oct 2022
- Primary completion5 Jan 2023
- Study completion30 Mar 2023
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 Insulin Dependent DiabetesStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 84 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serap Parlar Kılıç, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915338
- Sponsor's protocol ID
- INONU UNİV
- Acronym
- İNSÜLİN
- Status last verified
- Jun 2023
- First submitted
- 9 Jun 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozturk MH, Kerkez M, Kilic SP. The power of insulin education: enhancing pain and treatment perception in adult type 2 diabetes patients. J Diabetes Metab Disord. 2025 Jun 5;24(1):140. doi: 10.1007/s40200-025-01652-2. eCollection 2025 Jun.
PubMed 40485759
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Eof ıInsulin Use Education on Safe Drug Administration, Pain Level and Perception of Treatment in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05915338
- Acronym / sponsor ID
- İNSÜLİN / INONU UNİV
- Conditions
- Insulin Dependent Diabetes, Diabetes type2
- Keywords
- Tip 2 Diyabet, Güvenli İlaç Kullanımı, Tedavi Algısı, İnsülin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 23 Jun 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.
This study was conducted to evaluate the effect of individual insulin use training given to patients with type 2 diabetes using insulin on safe drug administration, pain level and perception of treatment. The study was conducted between October 2022 and March 2023 with a randomized control group.
Detailed description
Objective: The aim of this study was to examine the effects of individual insulin use training given to patients with Type 2 diabetes on safe drug administration, pain level and treatment perception, and to contribute to both national and international literature.
Method: It was conducted between October 2022 and March 2023 as a randomized controlled study in a pre-test-post-test order to determine the effect of individual insulin use education given to patients with type 2 diabetes on safe drug administration, pain level and treatment perception. The data were collected by the researchers with the descriptive information form of the patients, the Insulin Administration Skill Observation Form, the Visual Analogue Scale and the Insulin Therapy Evaluation Scale.
Data Collection: Face-to-face and individual interviews with patients who applied to the Internal Diseases and Endocrinology Polyclinic and Diabetes Nursing Polyclinics of a state hospital in a city located in the Southeastern Anatolia Region of Turkey, and who were hospitalized in the Internal Diseases, Endocrinology, Physical Therapy and Rehabilitation and Cardiology Services. collected using the method. A pilot study was not conducted before starting the study. Before the study, all patients were informed about the study and their verbal and written consents were obtained.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | –-Pre-test data were obtained by using the descriptive information form, İUBGF, VAS, and HRAS. The patients were asked to self-administer a dose of insulin that day, and the ability of the patients to administer the insulin dose was recorded in the IUBGF as the 1st follow-up by the researchers. Afterwards, individual insulin use training was given and the "Educational Manual on the Use of Insulin for Individuals with Type 2 Diabetes" was given to the patients and the first follow-up was completed. -2 weeks later, post-test data were obtained from the patients using IUBGF, VAS, and HRAS. The ability of the patients to administer the insulin dose was recorded in the IUBGF as the second follow-up by the researchers. After 8 weeks, post-test data were obtained by using IUBGF, VAS, and HRAS as retention tests. The ability of the patients to administer the insulin dose was recorded by the researchers as the 3rd follow-up retention test in IUBGF. |
| Control Group | – | –-Pre-test data were obtained by using the descriptive information form, İUBGF, VAS, and HRAS. The patients were asked to self-administer a dose of insulin that day, and the ability of the patients to administer the insulin dose was recorded in the IUBGF as the 1st follow-up by the researchers. -2 weeks later, post-test data were obtained from the patients using IUBGF, VAS, and HRAS. Patients were asked to self-administer a daily dose of insulin. The ability of the patients to administer the insulin dose was recorded in the IUBGF as the second follow-up by the researchers. After 8 weeks, post-test data were obtained by using IUBGF, VAS, and HRAS as retention tests. Patients were asked to self-administer a daily dose of insulin. The ability of the patients to administer the insulin dose was recorded in IUBGF as the 3rd follow-up retention test by the researchers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Type 2 Diabetes
Key inclusion criteria (5 listed)
- Patients included in the study;
- 18 years and over Using insulin injections for at least six months or longer
- Meeting the American Diabetes Association (ADA, 2021) diagnostic criteria for Type 2 diabetes
- No communication and mental problems
- Insulin injection made by himself or his family The patients who agreed to participate in the study.
Key exclusion criteria (5 listed)
- Patients excluded from the study;
- Self or family member health personnel Those with advanced retinopathy, nephropathy, neuropathy
- Diagnosed with type 1 diabetes
- Pregnant or breastfeeding women
- Patients who participated in another clinical trial concurrently or within 1 month prior to the start of the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fırst follow - up survey
Time frame: Fırst test-fırst applıcatıon both groups at the begınnıng of the research
Pretest data was obtained using the introductory information form, IASOF, VAS, and ITES. Patients were requested to apply their daily dose of insulin to themselves and patients' application skills were recorded by the researchers into IASOF as the 1st observation.
1 secondary outcome
Last test survey
Time frame: 2 weeks after the fırst watch
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 26 Jun 2023.
- Derived from this study: PubMed 40485759Ozturk MH, Kerkez M, Kilic SP. The power of insulin education: enhancing pain and treatment perception in adult type 2 diabetes patients. J Diabetes Metab Disord. 2025 Jun 5;24(1):140. doi: 10.1007/s40200-025-01652-2. eCollection 2025 Jun.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Dependent Diabetes and Diabetes type2, run by Inonu 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 5 inclusion and 5 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 26 Jun 2023. 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?
Fırst follow - up survey (time frame: Fırst test-fırst applıcatıon both groups at the begınnıng of the research). 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 NCT05915338, 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 26 Jun 2023; AzTrials last refreshed its copy on 2 Nov 2026.