A Mobile and Web-Based Clinical Decision Support and Monitoring System for Diabetes Mellitus Patients in Primary Care

Dokuz Eylül University (DEU)

Status: Unknown

Conditions: Diabetes Mellitus

Treatments: Other: Clinical decision support and monitoring system

Study type: Interventional

Funder types: Other

Identifiers

NCT02917226

2015/23-40

Details and patient eligibility

About

The purpose of the study is to develop a user-friendly, comprehensive, fully integrated web and mobile-based Clinical Decision Support and Monitoring System (CDSMS) for DM diseases screening, diagnosis, treatment and monitoring for the use of physicians and patients in primary care and to determine the effectiveness of the system. For validating the CDSMS for diabetes patients, randomized controlled trial will be conducted.A parallel single blind randomized controlled trial will be implemented. 10 physicians and their 439 patients are involved in the study. According to the results of screening which is done using developed CDSMS, DM diagnosed patients will be recruited for trial from the primary care centers by the physicians. The recruited patients will register to the CDSMS with their accounts given by their physicians. Eligible participants will be assigned to intervention and control groups with simple randomization. The significance level will be accepted as p<0,05. In the intervention group, the system recommendations on diagnosis, treatment and monitoring will be carried out as the final decision given by the physician. In the control group, physicians will treat DM patients as the general routine. Patients in both groups will be monitored for 6 months. Patient data on 0th and 6th month will be compared. Clinical and laboratory outcomes will be face-to-face assessed, others will be online self-assessed.

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Being over age 40
• Volunteer
• Computer and Internet literacy
• DM diagnosed or having at least one of diagnostic criteria.

These criteria;

• HbA1c ≥ 6.5
• FPG ≥ 126 mg / dl
• 2-hour postprandial glucose ≥ 200 mg / dl
• Any time postprandial glucose ≥ 200 mg / dl
• Diabetes symptoms

Exclusion criteria

• Having a communication problem
• Type 1 diabetes
• MODY type DM
• Level of psychiatric disorders in psychosis
• Dementia ones

Trial design

0 participants in 2 patient groups

Clinical decision support and monitoring system

Experimental group

Treatment:

Other: Clinical decision support and monitoring system

Control Group

No Intervention group