Effect of Artıfıcıal Intellıgence Based Mobıle Vırtual Assıstant

Diabetes Clinical Trial

— AI  

Official title:

Effect of Artıfıcıal Intellıgence Based Mobıle Vırtual Assıstant Developed For Indıvıduals Wıth Dıabetes On Cost Effıcıency, Hospıtal Admıssıon Rate, Self-Care And Hypoglycemıa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06079450
• Other study ID #: IKCU
• Status: Completed
• Start date: June 10, 2022
• Est. completion date: August 7, 2023

Study information

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

Clinical Trial Summary

Aim: This study was conducted experimentally to examine the effect of artificial intelligence-based mobile virtual assistant developed for individuals with diabetes on cost, hospitalization rate, self-care and hypoglycemia.

Methods: The research is multi-stage and designed as three stages in itself. According to this; development of the mobile application in the first and second stages and adding artificial intelligence to the application as a project; In the third stage, it was planned to examine the effect of the application on the variables and scales. The data of the study were collected between June 2022 and June 2023 in the Endocrinology Polyclinic of two private hospitals in Izmir and a diabetes association where individuals with diabetes were registered. Power 0.80 was determined by using NCSS PAS statistical software from the population of the research; The minimum number of samples to be included in the study was calculated as n:122 and they were divided into two as intervention and control groups by randomization. The research sample was carried out as intervention (n:60) and control (n:60) lastly due to death and cost. Five data collection tools were used, namely "Individual Introduction Form", "Diabetes Self-Care Scale", "Hypoglycemia Confidence Scale", "Mobile Application Opinion Form" and "Cost Table". An artificial intelligence-based mobile virtual assistant application was applied to the individuals with diabetes in the intervention group, and the data were collected three times, at the 0th, 6th and 12th months, and the costs were recorded. The standard outpatient trainings, which are currently applied, continued to be given to individuals with diabetes in the control group, the data were collected twice, at the beginning (0. month) and 12. months, and the costs were recorded. In the evaluation of the data, number, percentage, arithmetic mean, standard deviation, minimum and maximum median were calculated. Among the variables, chi-square, Kruskal Wallis, Mann Whitney U test and t test were used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: August 7, 2023
• Est. primary completion date: January 10, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Having been diagnosed with Type 1 and Type 2 diabetes at least six months ago, according to the criteria of the American Diabetes Association (ADA),

• Using insulin for at least six months,

• Being between the ages of 18- 65,

• Being able to read and write and speak Turkish,

• Having an Android phone and being able to use mobile applications,

• To volunteer to participate in the study.

Exclusion Criteria:

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Other:
• artificial intelligence based mobile application
Artificial intelligence-based mobile application developed by me that includes diabetes education for individuals with diabetes.

Locations

Country	Name	City	State
Turkey	Izmir Katip Celebi University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Tinaztepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes Self-Care Scale	The score consists of 35 items and is a 4-point Likert type, the lowest acceptable score is 92 and the highest score is 140. As the score increases, self-care increases	12 months
Primary	Hypoglycemic Confidence Scale	The scale consists of 9 items and is a 4-point Likert type. There is no cut-off value, the average score is used.	12 months
Secondary	hospitalization rate	percentage	12 months