NCT04721509

Brief Summary

Objective: evaluation of effect of smartphone based telemedicine and education in patients with type 1 diabetes mellitus Outline: Among the patients with type 1 diabetes, the group with telemedicine and education using smartphone set as a experimental group and the group without those set as a control group, respectively. Sample size: experimental group (n=50), control group (n=50) Inclusion criteria: patients with type 1 diabetes with A1c\>8.0% Exclusion criteria: chronic disease, psychological disease, children aged under 12 with parents with psychological disease, athletics Method: We divide subjects as an experimental group and a control group by randomization, and they visit outpatient clinic every 12 weeks. We perform telemedicine and education with smartphone application to the experimental group every 2 weeks. We evaluate the effect of smartphone based telemedicine and education in patients with type 1 diabetes mellitus with checking A1c and checklist at baseline, 12 weeks and 24 weeks after starting of the research. Variables: A1c, satisfaction, knowledge, self-confidence, willing to continuing, quality of life, physical activity, drinking, smoking Primary endpoint: Improvement in HbA1c of experimental group Secondary endpoint: No improvement in HbA1c of control group

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

1.6 years

First QC Date

January 21, 2021

Last Update Submit

January 21, 2021

Conditions

Type 1 Diabetes Mellitus

Keywords

Diabetes Mellitus, Telemedicine, Smartphone, Type 1, Child, Adolescent, Young Adult

Outcome Measures

Primary Outcomes (1)

  • change in HbA1c of experimental group

    6 months

Secondary Outcomes (1)

  • No change in HbA1c of control group

    6 months later

Study Arms (2)

Smartphone-based telemedicine

EXPERIMENTAL
Device: Experimental : Smartphone-based telemedicine with the app 'Songaree diabetes'

Conventional management without telemedicine

NO INTERVENTION

Interventions

Experimental : Smartphone-based telemedicine with the app 'Songaree diabetes'DEVICE

Experimental group: outpatient clinic and offline education every 12 weeks plus telemedicine and education with smartphone app 'Songaree diabetes' every 2 weeks for 24 weeks

Smartphone-based telemedicine

Eligibility Criteria

Age0 Months - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • chronic disease (except thyroid disorders with euthyroidism), psychological disease
  • Patients aged under 12 whose parents have psychological disease
  • Patients who cannot use smartphone app properly
  • athletics
  • Patients who use continuous glucose monitoring

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University College of Medicine

Seoul, South Korea

Location

Related Publications (7)

  • Maahs DM, West NA, Lawrence JM, Mayer-Davis EJ. Epidemiology of type 1 diabetes. Endocrinol Metab Clin North Am. 2010 Sep;39(3):481-97. doi: 10.1016/j.ecl.2010.05.011.

    PMID: 20723815RESULT

  • Song SO, Song YD, Nam JY, Park KH, Yoon JH, Son KM, Ko Y, Lim DH. Epidemiology of Type 1 Diabetes Mellitus in Korea through an Investigation of the National Registration Project of Type 1 Diabetes for the Reimbursement of Glucometer Strips with Additional Analyses Using Claims Data. Diabetes Metab J. 2016 Feb;40(1):35-45. doi: 10.4093/dmj.2016.40.1.35.

    PMID: 26912154RESULT

  • American Diabetes Association. 11. Microvascular Complications and Foot Care: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S135-S151. doi: 10.2337/dc20-S011.

    PMID: 31862754RESULT

  • American Diabetes Association. 6. Glycemic Targets: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S66-S76. doi: 10.2337/dc20-S006.

    PMID: 31862749RESULT

  • Phelan H, Lange K, Cengiz E, Gallego P, Majaliwa E, Pelicand J, Smart C, Hofer SE. ISPAD Clinical Practice Consensus Guidelines 2018: Diabetes education in children and adolescents. Pediatr Diabetes. 2018 Oct;19 Suppl 27:75-83. doi: 10.1111/pedi.12762. No abstract available.

    PMID: 30175451RESULT

  • Viana LV, Gomes MB, Zajdenverg L, Pavin EJ, Azevedo MJ; Brazilian Type 1 Diabetes Study Group. Interventions to improve patients' compliance with therapies aimed at lowering glycated hemoglobin (HbA1c) in type 1 diabetes: systematic review and meta-analyses of randomized controlled clinical trials of psychological, telecare, and educational interventions. Trials. 2016 Feb 17;17:94. doi: 10.1186/s13063-016-1207-6.

    PMID: 26888087RESULT

  • Sun C, Malcolm JC, Wong B, Shorr R, Doyle MA. Improving Glycemic Control in Adults and Children With Type 1 Diabetes With the Use of Smartphone-Based Mobile Applications: A Systematic Review. Can J Diabetes. 2019 Feb;43(1):51-58.e3. doi: 10.1016/j.jcjd.2018.03.010. Epub 2018 Mar 27.

    PMID: 30026048RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Ho-Seong Kim

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ho-Seong Kim

CONTACT

82-2-2228-2050kimho@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open label
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Inclusion criteria: patients with type 1 diabetes with A1c\>8.0% Exclusion criteria: chronic disease, psychological disease, children aged under 12 with parents with psychological disease, athletics Method: We divide subjects as an experimental group and a control group by randomization, and they visit outpatient clinic every 12 weeks. We perform telemedicine and education with smartphone application to the experimental group every 2 weeks. We evaluate the effect of smartphone based telemedicine and education in patients with type 1 diabetes mellitus with checking A1c and checklist at baseline, 12 weeks and 24 weeks after starting of the research.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2021

First Posted

January 22, 2021

Study Start

February 1, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)