NCT05915338

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

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

October 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

June 9, 2023

Last Update Submit

June 22, 2023

Conditions

Keywords

Tip 2 DiyabetGüvenli İlaç KullanımıTedavi Algısıİnsülin

Outcome Measures

Primary Outcomes (1)

  • 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.

    Fırst test-fırst applıcatıon both groups at the begınnıng of the research

Secondary Outcomes (1)

  • Last test survey

    2 weeks after the fırst watch

Other Outcomes (1)

  • Durabılıty test for both groups

    After 8 weeks, the follow-up test was done to both groups

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Type 2 Diabetes

You may qualify if:

  • Patients included in the study;
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şirnak Devlet Hastanesi

Şirnak, Merkez, 73000, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

June 9, 2023

First Posted

June 23, 2023

Study Start

October 1, 2022

Primary Completion

January 5, 2023

Study Completion

March 30, 2023

Last Updated

June 26, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations