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

Not Applicable

• Conditions: Diabetes Mellitus
• Interventions: Other: Clinical decision support and monitoring system

• Registration Number: NCT02917226
• Lead Sponsor: Dokuz Eylul University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-24
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-28
• Last Update Submitted: 2016-09-28
• Last Update Posted: 2016-09-29
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Clinical decision support and monitoring system	Clinical decision support and monitoring system	-

Primary Outcome Measures

Name	Time	Method
fasting blood glucose	Change from baseline fasting blood glucose at 6 months