Training on Using ıInsulin in Patients With Type 2 Diabetes

Diabetes type2 Clinical Trial

— INSÜLIN  

Official title:

The Eof ıInsulin Use Education on Safe Drug Administration, Pain Level and Perception of Treatment in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05915338
• Other study ID #: INONU UNIV
• Status: Completed
• Start date: October 1, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: June 2023
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 30, 2023
• Est. primary completion date: January 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Diabetes type2
• Insulin Dependent Diabetes

Locations

Country	Name	City	State
Turkey	Sirnak Devlet Hastanesi	Sirnak	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Durability 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
Primary	First 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.	First test-first application both groups at the beginning of the research
Secondary	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 first watch