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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02917226
Enrollment
Unknown
Registered
2016-09-28
Start date
Unknown
Completion date
Unknown
Last updated
2016-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

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.

Interventions

OTHERClinical decision support and monitoring system

Sponsors

Dokuz Eylul University
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum

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

Design outcomes

Primary

MeasureTime frame
fasting blood glucoseChange from baseline fasting blood glucose at 6 months

Contacts

Primary ContactVildan Mevsim, Prof., PhD, MD
vildan.mevsim@deu.edu.tr+905322360044

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026