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Determining the Effect of Home BLOOD Glucose Monitoring on HBA1C in Patients With Type 2 Diabetes Using Smartphone Application

NCT07647523 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-06-15

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effectiveness of a web and mobile-based clinical decision support and monitoring system (1B4T mobile application) on blood glucose control, medication adherence, quality of life, and self-management in patients with poorly controlled Type 2 Diabetes Mellitus.

This open-label, parallel-group, randomized controlled trial was conducted with 100 type 2 diabetes patients registered at primary care family health centers in Izmir, Turkey. Participants were randomly assigned to either the intervention group (n=50) or the control group (n=50).

* Intervention Group: Participants installed the 1B4T mobile application on their smartphones, created personal accounts, and recorded their home blood glucose measurements through the app for 3 months. The app allowed patients to track their previous data and view a 10-day blood glucose prediction without directing any treatment changes.
* Control Group: Participants continued with their routine healthcare follow-ups and standard controls.

At baseline and at the 3-month follow-up, fasting plasma glucose and HbA1c levels were measured for all participants. Additionally, sociodemographic characteristics, medication adherence (Modified Morisky Medication Adherence Scale), quality of life (WHOQOL-BREF-TR), and diabetes self-management (Diabetes Self-Management Questionnaire - DSMQ) were evaluated to assess the clinical and behavioral outcomes of the mobile health intervention.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

OTHER

Smartphone Application for Blood Glucose Monitoring

The intervention involves the use of the "1B4T" mobile application, a web and mobile-based clinical decision support and monitoring system developed with TUBITAK funding. Participants in the intervention group will receive a personalized username and password to log into their secure profiles on their smartphones. Patients are instructed to self-measure and log their blood glucose levels directly into the application over a 3-month period. Based on the user-entered data, the application generates and displays a 10-day blood glucose prediction, allowing patients to track their historical trends. The mobile software functions strictly as a data logging and monitoring platform for home self-management and does not provide any clinical guidance, treatment modification, or medication dosage adjustments.

Sponsors & Collaborators

  • Dokuz Eylul University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2021-08-01
Completion
2021-09-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07647523 on ClinicalTrials.gov