Diabetes Mellitus, Type 2NCT05658744
Video Training to Reduce Insulin Administration Errors
A study testing Video group in people with Diabetes Mellitus, Type 2 and Insulin Injection Pad, run by Goztepe Prof Dr Suleyman Yalcın City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Efficiency of training with video to reduce injection errors in patients using insulin Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Insulin Injection Pad, Injection Site
- What is being tested?
- Video group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2019to 25 Jan 2021
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mobile phone can download video
- video watching skills
Who cannot join
- illiterate patient
- new to insulin therapy
- who can't watch video on mobile phone
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Goztepe Prof Dr Suleyman Yalcın City Hospital
Kadıköy, Istanbul, 34722
About this study
Official title: Effect Of Reducing Insulin Implementation Errors In Education Compared To Routine Approach In Type 2 Diabetes Patients Using Insulin: A Randomized Controlled Study
Efficiency of training with video to reduce injection errors in patients using insulin
Read the detailed description
The aim of this study is to examine the effects of using insulin administration video and insulin administration brochure as teaching materials in insulin administration training given to type 2 diabetes patients on correcting insulin administration errors. This randomized controlled experimental study was carried out with 94 people who applied to the diabetes outpatient clinic of Istanbul Medeniyet University Goztepe Training and Research Hospital between December 2019 and January 2021. Using a computer-based randomization method, 52 and 42 people were assigned to the groups that received training with video and brochures, respectively. In the first interview, patients' insulin administration characteristics were evaluated, and the training was repeated using the video or brochure, after which the training material corresponding to the group according to the randomization list was given. Insulin administration characteristics of the patients were re-evaluated one week and three months later. Patient information form developed by the researcher based on the literature was used to collect the data. Data were analysed using descriptive statistics, independent sample t-test and Mann Whitney U test. The error rates in the interviews were analysed with the Cochrane Q test, and the relationship between independent categorical variables was examined with the Chi-square test.
- Conditions
- Diabetes Mellitus, Type 2, Insulin Injection Pad, Injection Site, Insulin Implementation Errors, Educational Problems
- Being tested
- Video group
- 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.
Video groupBehavioural
Insulin administration video was sent to the mobile phones of the patients assigned to the video group
| Study group | Role | What they receive |
|---|---|---|
| Video group | Experimental | Insulin administration video was shown to 52 patients with diabetes using insulin. The video was sent to the patients' mobile phones Receives: Behavioral: Video group |
| Brochure group | Experimental | Insulin administration leaflet was given to 42 patients with diabetes using insulin. Patients read the brochure aloud Receives: Behavioral: Video group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior change
Video training is effective in reducing insulin administration errors. There was no statistically significant difference between the groups in terms of sociodemographic characteristics of the individuals in the video and brochure group (p>0.05). The mean number of corrects in insulin administration increased from 12.94 to 20.15 in the group given the training video and from 14.33 to 18.67 in the group given the training brochure, with the patients who received video training having a higher mean number of corrects than the patients who received training with a brochure (t=2.69, p=0.009). In conclusion, retraining patients using insulin therapy with a video was found to be an effective approach to reduce insulin administration errors.
Measured: 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start25 Dec 2019
- Primary completion25 Jun 2020
- Study completion25 Jan 2021
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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goztepe Prof Dr Suleyman Yalcın City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gunes Feyizoglu, Goztepe Prof Dr Suleyman Yalcın City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658744
- Sponsor's protocol ID
- SuleymanYalcın
- Status last verified
- Dec 2022
- First submitted
- 3 Dec 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Feyizoglu GA, Can G. Injection Errors Are Still Common in Insulin Therapy! Could It be a Solution? J Eval Clin Pract. 2025 Jun;31(4):e70156. doi: 10.1111/jep.70156.
PubMed 40545932
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Reducing Insulin Implementation Errors In Education Compared To Routine Approach In Type 2 Diabetes Patients Using Insulin: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05658744
- Acronym / sponsor ID
- SuleymanYalcın
- Conditions
- Diabetes Mellitus, Type 2, Insulin Injection Pad, Injection Site, Insulin Implementation Errors, Educational Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Goztepe Prof Dr Suleyman Yalcın City HospitalUniversity, hospital or other
- Study start
- 25 Dec 2019 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 21 Dec 2022 (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.
Efficiency of training with video to reduce injection errors in patients using insulin
Detailed description
The aim of this study is to examine the effects of using insulin administration video and insulin administration brochure as teaching materials in insulin administration training given to type 2 diabetes patients on correcting insulin administration errors. This randomized controlled experimental study was carried out with 94 people who applied to the diabetes outpatient clinic of Istanbul Medeniyet University Goztepe Training and Research Hospital between December 2019 and January 2021. Using a computer-based randomization method, 52 and 42 people were assigned to the groups that received training with video and brochures, respectively. In the first interview, patients' insulin administration characteristics were evaluated, and the training was repeated using the video or brochure, after which the training material corresponding to the group according to the randomization list was given. Insulin administration characteristics of the patients were re-evaluated one week and three months later. Patient information form developed by the researcher based on the literature was used to collect the data. Data were analysed using descriptive statistics, independent sample t-test and Mann Whitney U test. The error rates in the interviews were analysed with the Cochrane Q test, and the relationship between independent categorical variables was examined with the Chi-square test.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video group | Experimental | Behavioral: Video groupInsulin administration video was shown to 52 patients with diabetes using insulin. The video was sent to the patients' mobile phones |
| Brochure group | Experimental | Behavioral: Video groupInsulin administration leaflet was given to 42 patients with diabetes using insulin. Patients read the brochure aloud |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- mobile phone can download video
- video watching skills
Key exclusion criteria (3 listed)
- illiterate patient
- new to insulin therapy
- who can't watch video on mobile phone
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 |
|---|---|---|
| Video groupInsulin administration video was sent to the mobile phones of the patients assigned to the video group | Behavioural | Brochure group, Video group |
Primary outcome
Behavior change
Time frame: 3 months later
Video training is effective in reducing insulin administration errors. There was no statistically significant difference between the groups in terms of sociodemographic characteristics of the individuals in the video and brochure group (p>0.05). The mean number of corrects in insulin administration increased from 12.94 to 20.15 in the group given the training video and from 14.33 to 18.67 in the group given the training brochure, with the patients who received video training having a higher mean number of corrects than the patients who received training with a brochure (t=2.69, p=0.009). In conclusion, retraining patients using insulin therapy with a video was found to be an effective approach to reduce insulin administration errors.
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 21 Dec 2022.
- Derived from this study: PubMed 40545932Feyizoglu GA, Can G. Injection Errors Are Still Common in Insulin Therapy! Could It be a Solution? J Eval Clin Pract. 2025 Jun;31(4):e70156. doi: 10.1111/jep.70156.
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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?
A study testing Video group in people with Diabetes Mellitus, Type 2 and Insulin Injection Pad, run by Goztepe Prof Dr Suleyman Yalcın City Hospital 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 2 inclusion and 3 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 21 Dec 2022. 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?
Behavior change (time frame: 3 months later). 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 NCT05658744, 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 21 Dec 2022.