Determining the Effect of Home BLOOD Glucose Monitoring on HBA1C in Patients With Type 2 Diabetes Using Smartphone Application
9. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
100
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Izmir, Tyrkia (Türkiye)
- Dokuz Eylul University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: Styre
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Eksperimentell: 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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Hemoglobin A1c (HbA1c)
Tidsramme: Baseline and 3 months
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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.
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Baseline and 3 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change in Fasting Plasma Glucose (FPG)
Tidsramme: Baseline and 3 months
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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.
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Baseline and 3 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. februar 2021
Primær fullføring (Faktiske)
1. august 2021
Studiet fullført (Faktiske)
1. september 2021
Datoer for studieregistrering
Først innsendt
9. juni 2026
Først innsendt som oppfylte QC-kriteriene
9. juni 2026
Først lagt ut (Faktiske)
15. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2019/29-25
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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.
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Nei
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