Type 2 Diabetes Clinical Trial
Official title:
The Effect of Gamification on Disease Self-Management and Glycemic Control in Patients With Type 2 Diabetes
Diabetes is a broad-spectrum metabolic disorder that causes a defect in the organism's carbohydrate, fat, and protein metabolism processes due to insulin deficiency or impaired insulin effect. Diabetes requires continuous medical care and causes chronic, severe mortality and morbidity. More than 90% of all people with diabetes worldwide suffer from Type 2 DM. Diabetes self-management includes self-monitoring of blood glucose levels, knowing and managing the symptoms of hypoglycemia and hyperglycemia, adherence to diet, physical exercise, and diabetic foot care. Considering the high prevalent and undesirable consequences of diabetes in the world, it is necessary to benefit from new educational technologies and tools. One of these technologies is gamification, which increases the quality of education as an effective educational tool, creates motivation and enthusiasm, and develops a sense of competition in the target audience. This study plans to develop a game that will include virtual coaching to increase the self-management and glycemic control of patients with type 2 diabetes.
Status | Recruiting |
Enrollment | 88 |
Est. completion date | December 30, 2023 |
Est. primary completion date | September 17, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Two years or more with a diagnosis of Type 2 DM - Patients using Insulin or Insulin and Oral Antidiabetic - No sensory loss, such as vision and hearing loss, - Having internet access and being able to use it, - Ability to use a mobile phone with an Android or IOS (iPhone OS) operating system - Patients who agreed to participate in the study Exclusion Criteria: - Patients diagnosed with Type 1 DM and Gestational DM. - Visual and auditory loss, - Individuals without internet access - Unable to communicate |
Country | Name | City | State |
---|---|---|---|
Turkey | Pelin ILHAN | Istanbul | Sisli |
Lead Sponsor | Collaborator |
---|---|
Sakarya University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | self-management scale | Determining whether or not the disease self-management scale scores in patients with Type 2 DM using the developed mobile game application increased at the end of the 6 weeks period. A minimum of 0 and a maximum of 10 points are obtained on the scale. If an item is skipped, it is evaluated as -3 points. Diabetes self-management increases as the score get closer to 10. | Change between the first day and the sixth week of the study | |
Secondary | glycemic control (HbA1c) | The effect that the mobile game application developed imposes on glycemic control in patients with Type 2 DM at six weeks compared to baseline.
The effect of the patient's HbA1c tests on the 6th week compared to the baseline. Blood test (HbA1c) will be performed during the outpatient follow-up at the first and sixth weeks. |
Change between day one and week 6 of the study | |
Secondary | anthropometric measurements (Body Mass Index) | The effects on anthropometric measurements in patients with Type 2 DM using the mobile game application developed compared to baseline at week 6.
The effect on the patient's Body Mass Index compared to baseline at week 6. The researcher will measure it. Body Mass Index is calculated by dividing the person's weight in kilograms by the square of the person's height in meters (kg/m²). |
The change between the first day and the sixth week of the study |
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