Diabetes Mellitus, Type 2
Conditions
Brief 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.
Interventions
OTHERSmartphone 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
Dokuz Eylul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c (HbA1c) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Plasma Glucose (FPG) | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed