Diabetes Mellitus, Type 2NCT07647523
Determining the Effect of Home BLOOD Glucose Monitoring on HBA1C in Patients With Type 2 Diabetes Using Smartphone Application
A study testing Smartphone Application for Blood Glucose Monitoring in people with Diabetes Mellitus, Type 2, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Smartphone Application for Blood Glucose Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
- 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
- Being tested
- Smartphone Application for Blood Glucose Monitoring
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone Application for Blood Glucose MonitoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Intervention | Experimental | 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. Receives: Other: Smartphone Application for Blood Glucose Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c (HbA1c)
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.
Measured: Baseline and 3 months
Secondary outcomes (1)
Change in Fasting Plasma Glucose (FPG)
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.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Feb 2021
- Primary completion1 Aug 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oğulcan Çöme, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647523
- Sponsor's protocol ID
- 2019/29-25
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effect of Home BLOOD Glucose Monitoring on HBA1C in Patients With Type 2 Diabetes Using Smartphone Application
- ClinicalTrials.gov ID
- NCT07647523
- Acronym / sponsor ID
- 2019/29-25
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Intervention | Experimental | Other: Smartphone Application for Blood Glucose MonitoringParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone Application for Blood Glucose MonitoringThe 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. | Other | Intervention |
Primary outcome
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.
1 secondary outcome
Change in Fasting Plasma Glucose (FPG)
Time frame: Baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone Application for Blood Glucose Monitoring in people with Diabetes Mellitus, Type 2, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin A1c (HbA1c) (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.