NCT06620094

Brief Summary

Objective:This study aims to determine the effect of a mobile application on diabetes control in patients with Type 2 diabetes. Methods:This study is a randomized controlled trial with a pre-test and post-test design. The study population consists of Type 2 diabetes patients who applied to the Endocrinology Clinic of Malatya Turgut Özal Medical Center. A total of 70 participants were included in the study. Data were collected face-to-face using a demographic data collection form, a diabetes diagnosis and follow-up form, and the Turkish Multidimensional Diabetes Scale. The data were analyzed using paired t-tests and independent samples t-tests to compare means, counts, and percentages in dependent and independent groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

7 months

First QC Date

September 24, 2024

Last Update Submit

September 26, 2024

Conditions

Keywords

Diabetes mellitus, glycated hemoglobin A, mobile applications

Outcome Measures

Primary Outcomes (1)

  • A1C levels

    Hemoglobin A1C (HbA1C): HbA1C is a blood test that measures the average blood glucose levels over the past two to three months by determining the percentage of glycated hemoglobin in the blood. It is commonly used to diagnose diabetes and assess the effectiveness of diabetes management. An HbA1C level below 5.7% is considered normal, between 5.7% and 6.4% indicates prediabetes, and a level of 6.5% or higher indicates diabetes.

    up to seven months

Study Arms (2)

Intervention Group

EXPERIMENTAL

This group, used mobile application and underwent routine controls.

Other: diabetes education videos

Control Group

NO INTERVENTION

This group, underwent only routine controls.

Interventions

In the initial meeting during the preparation phase, participants in the experimental group were informed about the notifications and diabetes education videos that would be sent to their phones. Afterward, the patients received three notifications daily, every day of the week. The first notification requested them to ;measure and record their fasting and postprandial blood sugar in the morning; The second notification instructed them to ;exercise for at least 30 minutes a day.; The third notification asked them to ;record the foods they consumed and their quantities, and to measure and record their evening fasting and postprandial blood sugar, as well as their blood sugar before going to bed.; Additionally, during their routine outpatient follow-ups, the results of their tests (A1C, BMI, total cholesterol, HDL, LDL, triglycerides), blood pressure, and weight measurements were recorded. Furthermore, three times a week, participants were asked to ;measure and record their blood pressur

Intervention Group

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having been diagnosed with type 2 diabetes mellitus for at least 6 months. Being between the ages of 40-65. Receiving oral antidiabetic treatment. Having an A1C value between 7%-10%. Owning a mobile phone capable of receiving and playing video messages. Not having sensory impairments, such as hearing or speech loss, or psychiatric problems that prevent communication.

You may not qualify if:

  • Inability to use the mobile application. Patients with a psychological diagnosis according to records. Patients using insulin. Having an A1C value above 10%. Having an infection requiring medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, Malatya, 44280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Rukuye AYLAZ, Prof. Dr.

    Inonu University Faculty of Nursing

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is a pre-test, post-test randomized controlled experimental study. Therefore this study there is two groups: Intervention and control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Asistant

Study Record Dates

First Submitted

September 24, 2024

First Posted

October 1, 2024

Study Start

May 30, 2021

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

October 1, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

The data are not open to public due to confidentiality and ethical restrictions.

Locations