The Effect of Remote Patient Education and Follow-up on Pancreatic Beta Cell Function and Indices of Sensitivity and Resistance of Body Cells to Insulin in Patients with Type 2 Diabetes

Examining the Effect of Remote Patient Education and Follow-up on Pancreatic Beta Cell Function and Indices of Sensitivity and Resistance of Body Cells to Insulin in Patients with Type 2 Diabetes

A parallel-group, double-blind, randomized, phase 3 Clinical trial with a control group on 66 patients

Patient recruitment and basic educational sessions will be conducted at the Diabetes Association Center in Urmia city. Subsequently, remote educational interventions and follow-ups will be implemented as described above. The control group will receive only routine educations provided by the center.

Diabetic patients aged 18 to 60 years who have hemoglobin A1C level between 6.5-8, the ability to read and writeو and using a mobile phone can participate in this study.

Telephone calls will be made twice a week by the researcher to the participants. The conversations will include assessment of blood glucose control in terms of diet, exercise, and medications, as well as providing suggested solutions for any issues with blood glucose control. Additionally, instructions will be given on foot care and the consequences of neglecting foot hygiene and smoking. Smokers will be encouraged to quit smoking and referred to counseling centers. Through the ITA messaging app, messages containing text, videos, and audio related to blood glucose control, foot care, and smoking-related consequences will be sent. One message will be sent daily, each message will be numbered for tracking reading compliance.

Pancreatic Beta Cell Function (HOMA-β), Indices of Sensitivity and Resistance of Body Cells to Insulin (HOMA-IR)

Block randomization will be used to assign patients to the control and intervention groups, so that 6 blocks with size of 4 will be used in this regard. The letter A and B will be considered for sampling patients in the intervention and the control group, respectively. The following blocks will be written on pieces of paper with numbers from 1 to 6. We will then randomly pick up the pieces of paper through rolling a dice. Sampling will then begin according to the order achieved in the above procedures. 1. AABB 2. BBAA 3. ABBA 4. BAAB 5. ABAB 6. BABA According to the order of the letters in the blocks, patients will be assigned to the intervention or control group. Then the next blocks will be selected through rolling the dice again. For example, we roll the dice 6 times for the first time and the following numbers are given by chance: 514362 → ABAB AABB BAAB ABBA BABA BBAA

In this clinical trial, we will implement single blinding by ensuring that the statistical analyzer does not know which group is the intervention or control. The groups will be labeled with abbreviated names, "A" and "B," instead of their actual designations. This approach prevents bias in data analysis, as the analyzer cannot associate the data with the specific treatment groups. This method will maintain the integrity and objectivity of the present trial results.

Upon completion of the study, the researchers will publish the necessary information in the article while adhering to ethical considerations. Therefore, the required demographic information and the scores related to the dependent variables of the article or resulting articles will be published.

The article resulting from this project is expected to be available within the next six months, and most of the data will be included in the article. Additional data will be provided in accordance with the Ethics Committee's regulations and the researchers' decisions.

The data and documentation will be accessible to researchers in the fields of medical sciences and other related domains.

The data will be available for study, citation, generating new ideas, and practical use in educational and healthcare centers. Adherence to ethical standards in research will be a priority in decision-making for data publication.

To request data, you can email the corresponding author of this research project at: nparizad@gmail.com.

Researchers can use the available data by providing reasons and ensuring they will reference the resulting articles by emailing the corresponding author at: nparizad@gmail.com.