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

NCT02917226 | Unknown

• 1 other identifier: 2015/23-40
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• fasting blood glucose

  Change from baseline fasting blood glucose at 6 months

Study Arms (2)

Clinical decision support and monitoring system

EXPERIMENTAL

Other: Clinical decision support and monitoring system

Control Group

NO INTERVENTION

Interventions

Clinical decision support and monitoring system OTHER

Clinical decision support and monitoring system

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• hour postprandial glucose ≥ 200 mg / dl
• Any time postprandial glucose ≥ 200 mg / dl
• Diabetes symptoms

You may not qualify if:

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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Related Publications (1)

• Kart O, Mevsim V, Kut A, Yurek I, Altin AO, Yilmaz O. A mobile and web-based clinical decision support and monitoring system for diabetes mellitus patients in primary care: a study protocol for a randomized controlled trial. BMC Med Inform Decis Mak. 2017 Nov 29;17(1):154. doi: 10.1186/s12911-017-0558-6.

  PMID: 29187186 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Vildan Mevsim, Prof., PhD, MD

CONTACT

+905322360044; vildan.mevsim@deu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr. Vildan MEVSİM, MD, PhD

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 28, 2016
• Primary Completion: December 1, 2017
• Last Updated: September 29, 2016

Record last verified: 2016-09