The Effect of Education and Tele-Follow-Up Program on Diabetes Self-Management and Blood Glucose Regulation

NCT06963073 | Not Yet Recruiting DMC

• 1 other identifier: COMU-SBF-NA-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This study is designed as a randomized controlled trial to determine the effects of education and the Tele-Follow-up program on the disease knowledge, self-management, and blood glucose regulation of newly diagnosed Type 2 diabetes patients.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus; Self-Management; Blood Glucose Regulation

Outcome Measures

Primary Outcomes (2)

• Diabetes Self-Management Scale

  As a result of the study by Koç and his colleagues, a new measurement tool called "Type 2 Diabetes Self-Management Scale" was developed. A minimum of 19 and a maximum of 95 points can be obtained from the scale. There is no cut-off score range for the scale. According to the total score average, high scores indicate good self-management, while low scores indicate poor self-management.

  Baseline and after 6 months

• Adult Diabetes Knowledge Scale

  The scale was developed by Erener Yavuz and Erol (2019) to measure the knowledge levels of adult diabetic individuals. The maximum score that can be obtained from the scale is 28, and the minimum score is 0. Scores between 14 and 28 indicate a high level of knowledge, while scores below 14 indicate insufficient level of knowledge.

  Baseline and after 6 months

Study Arms (2)

Diabetic DM

EXPERIMENTAL

The intervention group will consist of 30 people. This group will be given 45 minutes of diabetes education (nutrition, exercise, medication, treatment, insulin administration, etc.).

Other: Diabetic DM

Control group

NO INTERVENTION

The control group will consist of 30 people. No training will be given to this group. Only a brochure containing brief diabetes information will be given.

Interventions

Diabetic DM OTHER

The intervention group will receive 45 minutes of diabetes education. Three telemonitoring sessions will be held 2 weeks, 1 month and 3 months after the education. During the monitoring, participants will be asked to monitor their blood sugar and HbA1C values, if any. Nothing will be done to the control group. The same monitoring will be held for the control group 3 months later.

Also known as: Diabetes training

Diabetic DM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteering to participate in the study.
• Having recently been diagnosed with Type 2 Diabetes.
• Not having cognitive dysfunction.
• Not having done diabetes education before.

You may not qualify if:

• Being under 18 years of age.
• Having cognitive dysfunction.
• Not volunteering to participate in the study.

Sponsors & Collaborators

• Çanakkale Onsekiz Mart University: lead

Study Sites (2)

Çanakkale Onsekiz Mart University, Faculty of Health Sciences

Çanakkale, 17100, Turkey (Türkiye)

Location

Çanakkale Onsekiz Mart University, Faculty of Health Sciences

Çanakkale, Çanakkale, 17100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• NAİLE ALANKAYA, Assosiate Prof.

  Çanakkale Onsekiz Mart University, Faculty of Health Sciences

  STUDY DIRECTOR

Central Study Contacts

Naile Alankaya, Assosiate Prof. PhD

CONTACT

+905334256510; nailealankaya@comu.edu.tr

Ceyda Albayrak

CONTACT

+905488860535; ceycealbayrak@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, PhD

Model Details: In the research, firstly, a pre-test (Introductory Information Form, "Adult Diabetes Knowledge Scale" to assess their knowledge about the disease, and the "Diabetes Self-Management Scale) will be applied to intervention and control groups. Blood glucose levels and Hemoglobin A1c (HbA1c) values will be obtained from the patients' hospital records on the day of measurement. In the randomized experimental group, participants will receive one-on-one face-to-face diabetes education. Participants in the control group will receive only the educational booklet prepared by the researcher, without any formal education. Participants who attended the training will be contacted by phone at least three times-two weeks, one month, and two months after the training. After the applications are completed, a posttest.If available, fasting blood glucose and Hemoglobin A1c values will be obtained from the hospital records on the corresponding date.

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 8, 2025
• Study Start: June 15, 2025
• Primary Completion: September 15, 2025
• Study Completion: December 30, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)