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Diabetes Mellitus, Type 2NCT05228561

The Effect of Mobile Application Supported Diabetes Education On Type 2 Diabetes Self-Management And Blood Sugar Level

A study testing Mobile Application Supported Nutrition and Diabetes Education in people with Diabetes Mellitus, Type 2 and Education, run by Ege University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Diabetes is one of the biggest public health problems of the 21st century. Type 2 diabetes mellitus accounts for more than 90% of all diabetes cases and is the most common type of diabetes. Read more about this study

Who is it for?
Ages 18 to 64 years
What is being tested?
Mobile Application Supported Nutrition and Diabetes Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
No sites listed yet
Study dates
15 Mar 2022to 15 Nov 2022
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 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Newly diagnosed type 2 diabetes patients in the endocrinology and metabolism outpatient clinic of Ege University Medical Faculty Hospital.
  • Patients with Type 2 DM, between the ages of 18-64, using smart phones and having regular internet will be included in the study.

Who cannot join

  • Those who receive regular messages every day will be checked, and those who do not open/read more than 25% of the messages in total will be excluded.
  • type 1 diabetes or gestational diabetes

About this study

Official title: The Effect of Mobile Application Supported Diabetes Education On Type 2 Diabetes Self-Management And Blood Sugar In Newly Diagnosed Type 2 Diabetes Patients

Diabetes is one of the biggest public health problems of the 21st century. Type 2 diabetes mellitus accounts for more than 90% of all diabetes cases and is the most common type of diabetes. Type 2 diabetes, in which genetic and environmental factors play a role,It is a metabolic disorder in which insulin resistance, decrease in insulin secretion and incretin hormone deficiency are effective in its physiopathology, characterized by polydipsia, polyphagia and polyuria, where the organism cannot adequately benefit from carbohydrates, fats and proteins due to insulin deficiency or defects in the effect of insulin, which requires continuous medical care.

Diabetes is a major cause of blindness, end-stage renal disease, coronary artery disease, stroke and inferior extremity amputations. These complications due to diabetes impair the patient's quality of life and impose social, financial and emotional burdens on both the patient and their family.

Read more

Diabetes education should be provided by healthcare professionals in order to ensure that diabetes patients knowledge and skills to prevent complications and provide better self management and self-care.

However, The fact that individuals do not have time to spare for face-to-face health education, the possibility of accessing information in the web environment repeatedly and the lower cost of education in the web environment compared to classical education increases the importance of web-based health education. The widespread use of mobile technologies in recent years has led to the development of new mobile applications related to diabetes.

The disquisition proposal the investigators prepared was created to investigate the effect of mobile application supported diabetes and nutrition education on type 2 diabetes self-management and blood sugar in newly diagnosed type 2 diabetes patients.

In this context, with the development of a mobile application prepared in visual, text and video format to provide diabetes education, the monitoring of blood parameters before and after diabetes education, and the implementation of the Type 2 Diabetes Self-Management Scale, (which consists of 19 items developed in 2020), and type 2 diabetes self-management and the effect on blood sugar will be examined. This study will provide answers to questions about the effectiveness of diabetes education given to Type 2 Diabetes patients via mobile applications on diabetes self-management and blood parameters.

Being tested
Mobile Application Supported Nutrition and Diabetes Education
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.

  • Mobile Application Supported Nutrition and Diabetes EducationOther

    With this intervention, the difference between the mobile application supported nutrition diabetes education created with written and visual (video) and face-to-face nutrition and diabetes education will be found.

Study groups in NCT05228561
Study groupRoleWhat they receive
Control GroupNo interventionAfter the physician involved in the study asks the participants for their biochemical tests (FBC, HbA1C, LDL-C, HDL-C, Total K, Triglyceride), the outpatient dietitian will give routine nutrition education to the participants. In addition, a data collection form including socio-demographic information, health history, nutrition history and height, weight, waist circumference measurements will be made and filled by the thesis student.
Study GroupExperimentalThe software developed for this research will be downloaded to the phones of the participants in the intervention group. With this software prepared, written and visual information (pictures, mini-videos) will be given to participants every day for 3 months on diabetes, self-management of diabetes and nutrition. Whether the participants read the messages or not will also be monitored through this software. At the end of 3 months, the participants in the intervention and control groups will be invited again, and their biochemical parameters and self-management status will be measured according to the diabetes self-management scale. Data will be collected through face-to-face interviews in the outpatient clinic, and weight will be measured with the bioelectrical impedance analyzer in the outpatient clinic, height will be measured with a height meter fixed to the wall, and waist circumference will be measured with a non-stretchable measuring tape.
Receives: Other: Mobile Application Supported Nutrition and Diabetes Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The effect of mobile application supported diabetes education on type 2 diabetes self-management.

    Type 2 diabetes self-management scores of the participants in the study group and control group will be compared.

    For this comparison, the "Type 2 Diabetes Self-Management Scale" consisting of 3 sub-titles (Healthy Lifestyle Behaviors, Blood Sugar Management, Health Services Use) and 19 items developed in 2020 will be applied.

    (Scoring: Always 5, Often 4, Sometimes 3, Rarely 2, Never 1 point). Those with higher scores will be considered to show better self-management. This scale will first be administered to the participants when they are diagnosed with type 2 diabetes in the hospital.

    Participants will be given diabetes and nutrition education for 3 months, and the Type 2 Diabetes Self-Management Scale will be repeated by inviting them to the hospital for control.

    Then, the participants will be taken into a 3-month follow-up process and at the end of the process, they will be invited to the hospital for control and the Type 2 Diabetes Self-Management Scale will be repeated.

    Measured: 6 Month

  2. The effect of mobile application supported diabetes education on blood sugar

    The physician participating in the study will measure the Fasting Blood Sugar (mg/dl) values of the participants.

    When the participants are diagnosed with type 2 diabetes, their Fasting Blood Sugar (mg/dl) values will be measured and a 3-month diabetes education will be given. At the end of this diabetes training, the participants will be invited to the hospital for control and their Fasting Blood Sugar (mg/dl) values will be measured again.

    Then, the participants will be taken to the 3-month follow-up process and at the end of the process, the participants will be invited to the hospital for control and their Fasting Blood Sugar (mg/dl) values will be measured again.

    At the end of the research, the effects of mobile application supported diabetes education on fasting blood sugar (mg/dl) will be compared with the routine diabetes education given in the hospital.

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2022
  2. Study start15 Mar 2022 (estimated)
  3. Primary completion15 Sep 2022 (estimated)
  4. Study completion15 Nov 2022 (estimated)

Resources

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
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05228561
Sponsor's protocol ID
EgeUniversity-ETURHAN-001
Status last verified
Jan 2022
First submitted
30 Dec 2021
Last updated
8 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zimmet P, Alberti KG, Magliano DJ, Bennett PH. Diabetes mellitus statistics on prevalence and mortality: facts and fallacies. Nat Rev Endocrinol. 2016 Oct;12(10):616-22. doi: 10.1038/nrendo.2016.105. Epub 2016 Jul 8.

    PubMed 27388988
  • Satman I, Yilmaz T, Sengul A, Salman S, Salman F, Uygur S, Bastar I, Tutuncu Y, Sargin M, Dinccag N, Karsidag K, Kalaca S, Ozcan C, King H. Population-based study of diabetes and risk characteristics in Turkey: results of the turkish diabetes epidemiology study (TURDEP). Diabetes Care. 2002 Sep;25(9):1551-6. doi: 10.2337/diacare.25.9.1551.

    PubMed 12196426
  • Satman I, Omer B, Tutuncu Y, Kalaca S, Gedik S, Dinccag N, Karsidag K, Genc S, Telci A, Canbaz B, Turker F, Yilmaz T, Cakir B, Tuomilehto J; TURDEP-II Study Group. Twelve-year trends in the prevalence and risk factors of diabetes and prediabetes in Turkish adults. Eur J Epidemiol. 2013 Feb;28(2):169-80. doi: 10.1007/s10654-013-9771-5. Epub 2013 Feb 14.

    PubMed 23407904
  • Sami W, Ansari T, Butt NS, Hamid MRA. Effect of diet on type 2 diabetes mellitus: A review. Int J Health Sci (Qassim). 2017 Apr-Jun;11(2):65-71.

    PubMed 28539866
  • Millar A, Cauch-Dudek K, Shah BR. The impact of diabetes education on blood glucose self-monitoring among older adults. J Eval Clin Pract. 2010 Aug;16(4):790-3. doi: 10.1111/j.1365-2753.2009.01195.x. Epub 2010 Jun 14.

    PubMed 20557415
  • Powers MA, Bardsley JK, Cypress M, Funnell MM, Harms D, Hess-Fischl A, Hooks B, Isaacs D, Mandel ED, Maryniuk MD, Norton A, Rinker J, Siminerio LM, Uelmen S. Diabetes Self-management Education and Support in Adults With Type 2 Diabetes: A Consensus Report of the American Diabetes Association, the Association of Diabetes Care & Education Specialists, the Academy of Nutrition and Dietetics, the American Academy of Family Physicians, the American Academy of PAs, the American Association of Nurse Practitioners, and the American Pharmacists Association. Diabetes Care. 2020 Jul;43(7):1636-1649. doi: 10.2337/dci20-0023. Epub 2020 Jun 8. No abstract available.

    PubMed 32513817
  • Chomutare T, Fernandez-Luque L, Arsand E, Hartvigsen G. Features of mobile diabetes applications: review of the literature and analysis of current applications compared against evidence-based guidelines. J Med Internet Res. 2011 Sep 22;13(3):e65. doi: 10.2196/jmir.1874.

    PubMed 21979293
  • El-Gayar O, Timsina P, Nawar N, Eid W. Mobile applications for diabetes self-management: status and potential. J Diabetes Sci Technol. 2013 Jan 1;7(1):247-62. doi: 10.1177/193229681300700130.

    PubMed 23439183
  • Kelly L, Jenkinson C, Morley D. Experiences of Using Web-Based and Mobile Technologies to Support Self-Management of Type 2 Diabetes: Qualitative Study. JMIR Diabetes. 2018 May 11;3(2):e9. doi: 10.2196/diabetes.9743.

    PubMed 30291098
  • Norris SL, Lau J, Smith SJ, Schmid CH, Engelgau MM. Self-management education for adults with type 2 diabetes: a meta-analysis of the effect on glycemic control. Diabetes Care. 2002 Jul;25(7):1159-71. doi: 10.2337/diacare.25.7.1159.

    PubMed 12087014
  • Calderon JL, Shaheen M, Hays RD, Fleming ES, Norris KC, Baker RS. Improving Diabetes Health Literacy by Animation. Diabetes Educ. 2014 May;40(3):361-372. doi: 10.1177/0145721714527518. Epub 2014 Mar 27.

    PubMed 24676274
  • Abrar EA, Yusuf S, Sjattar EL, Rachmawaty R. Development and evaluation educational videos of diabetic foot care in traditional languages to enhance knowledge of patients diagnosed with diabetes and risk for diabetic foot ulcers. Prim Care Diabetes. 2020 Apr;14(2):104-110. doi: 10.1016/j.pcd.2019.06.005. Epub 2019 Jul 13.

    PubMed 31311727
  • American Diabetes Association. Standards of medical care in diabetes--2014. Diabetes Care. 2014 Jan;37 Suppl 1:S14-80. doi: 10.2337/dc14-S014. No abstract available.

    PubMed 24357209

Questions about this trial

What is this clinical trial studying?

A study testing Mobile Application Supported Nutrition and Diabetes Education in people with Diabetes Mellitus, Type 2 and Education, run by Ege University.

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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

The effect of mobile application supported diabetes education on type 2 diabetes self-management. (time frame: 6 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05228561, which also lists 13 linked publications.

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 8 Feb 2022.

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