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

June 9, 2026 updated by: Oğulcan Çöme, Dokuz Eylul University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Volunteering to participate in the study.
  • Having poorly controlled Type 2 Diabetes Mellitus (HbA1c > 7%).
  • Using a smartphone.
  • Being over 18 years of age.
  • Ability to speak and understand Turkish.
  • Being at least a primary school graduate.
  • Having full orientation to person, place, and time.

Exclusion Criteria:

  • Having participated in any diabetes-related study within the last 3 months.
  • Inability to attend regular clinical follow-up visits.
  • Having severe visual or hearing impairments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Intervention
Participants in this arm will use the 1B4T mobile application for home blood glucose monitoring over a 3-month period. Each participant will receive a unique username and password to access their private profile on the smartphone application. Patients will record their self-measured blood glucose levels directly into the app. The digital platform allows them to monitor their historical data and view a 10-day blood glucose prediction generated by the system's clinical decision support software. The application functions strictly as a tracking and monitoring tool and does not direct, alter, or modify any medical treatment. Follow-up clinical and behavioral assessments (HbA1c, fasting plasma glucose, medication adherence, quality of life, and self-management scales) will be conducted at the end of the 3rd month.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hemoglobin A1c (HbA1c)
Time Frame: Baseline and 3 months
The mean change in Hemoglobin A1c (HbA1c) levels from baseline to the end of the 3rd month will be evaluated to assess glycemic control. HbA1c is measured as a percentage (%) to reflect the average blood glucose levels over the past 3 months.
Baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fasting Plasma Glucose (FPG)
Time Frame: Baseline and 3 months
The mean change in fasting plasma glucose levels (measured in mg/dL) from baseline to the end of the 3rd month will be evaluated to monitor short-term glycemic variations between the groups.
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dokuz Eylul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

June 9, 2026

First Submitted That Met QC Criteria

June 9, 2026

First Posted (Actual)

June 15, 2026

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/29-25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be publicly available to protect participant confidentiality and comply with institutional review board (IRB) restrictions. However, de-identified IPD underlying the results reported in future publications may be shared with qualified researchers upon a reasonable and scientifically sound request. Data access requires a formal proposal outlining the study's specific aims, approval from the principal investigator and the relevant ethics committee, and the execution of a formal data use agreement. Requests should be directed to the principal investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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