NCT05725330

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 22, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

February 25, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

December 22, 2022

Last Update Submit

February 2, 2023

Conditions

GamificationType 2 DiabetesSelf-managementDigital HealthMobile Application

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • glycemic control (HbA1c)

    Change between day one and week 6 of the study

  • anthropometric measurements (Body Mass Index)

    The change between the first day and the sixth week of the study

Study Arms (2)

Intervention Group

EXPERIMENTAL

Application of data collection forms for the initial evaluation. Teaching the use of mobile games, monitoring the use of mobile games in the experimental group by the researcher for six weeks, and applying data collection forms to the patients in the sixth week.

Other: Gamification and education with mobile game application

Control Group

NO INTERVENTION

Application of data collection forms for the initial evaluation. Application of data collection forms to the patients in the sixth week. No intervention will be made to the patients in the control group other than the routine education given in the diabetes outpatient clinic.

Interventions

Gamification and education with mobile game applicationOTHER

This study aimed to provide self-care management by playing mobile games to patients with type 2 diabetes.

Intervention Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients diagnosed with Type 1 DM and Gestational DM.
  • Visual and auditory loss,
  • Individuals without internet access
  • Unable to communicate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pelin ILHAN

Istanbul, Sisli, 34360, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

Pelin ILHAN, MSc

CONTACT

+905312711494pelinilhan.54@hotmail.com

Havva SERT, PhD

CONTACT

+905422512100hsert@sakarya.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2022

First Posted

February 13, 2023

Study Start

February 25, 2023

Primary Completion

September 17, 2023

Study Completion

December 30, 2023

Last Updated

February 13, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)