Training on Using ıInsulin in Patients With Type 2 Diabetes (İNSÜLİN)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes type2; Insulin Dependent Diabetes

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 Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• Turkey
  • Merkez
    • Şirnak, Merkez, Turkey, 73000
      • Şirnak Devlet Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients with Type 2 Diabetes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks after the fırst watch

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Durabılıty test for both groups	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 3rd observation.	After 8 weeks, the follow-up test was done to both groups

Collaborators and Investigators

• Sponsor: Inonu University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): January 5, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: June 21, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Tip 2 Diyabet; Güvenli İlaç Kullanımı; Tedavi Algısı; İnsülin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Other Study ID Numbers: INONU UNİV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No