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

9. juni 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Styring
Eksperimentel: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Hemoglobin A1c (HbA1c)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Fasting Plasma Glucose (FPG)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Dokuz Eylul University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. februar 2021

Primær færdiggørelse (Faktiske)

1. august 2021

Studieafslutning (Faktiske)

1. september 2021

Datoer for studieregistrering

Først indsendt

9. juni 2026

Først indsendt, der opfyldte QC-kriterier

9. juni 2026

Først opslået (Faktiske)

15. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2019/29-25

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

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Kliniske forsøg med Diabetes mellitus, type 2

Kliniske forsøg med Smartphone Application for Blood Glucose Monitoring

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Pakistan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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