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Effect of Smartphone Based Telemedicine and Education in Patients With Type 1 Diabetes Mellitus

Primary Purpose

Type 1 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Experimental : Smartphone-based telemedicine with the app 'Songaree diabetes'
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Diabetes Mellitus, Telemedicine, Smartphone, Type 1, Child, Adolescent, Young Adult

Eligibility Criteria

0 Months - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

a. patients aged under 30 with type 1 diabetes b. patients who control glucose level with multiple daily injection of insulin pump c. Patients who agree the task to check glucose level during the experiment d. patients who has been diagnosed as type 1 diabetes more than 3 months e. patients whose A1c more than 8.0% within 6 months f. Patients who can use smartphone all day 2) exclusion criteria

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

Exclusion Criteria:

-

Sites / Locations

  • Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Smartphone-based telemedicine

Conventional management without telemedicine

Arm Description

Outcomes

Primary Outcome Measures

change in HbA1c of experimental group

Secondary Outcome Measures

No change in HbA1c of control group

Full Information

First Posted
January 21, 2021
Last Updated
January 21, 2021
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT04721509
Brief Title
Effect of Smartphone Based Telemedicine and Education in Patients With Type 1 Diabetes Mellitus
Official Title
Effect of Smartphone Based Telemedicine and Education in Patients With Type 1 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 2021 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Diabetes Mellitus, Telemedicine, Smartphone, Type 1, Child, Adolescent, Young Adult

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
Open label
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Smartphone-based telemedicine
Arm Type
Experimental
Arm Title
Conventional management without telemedicine
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Experimental : Smartphone-based telemedicine with the app 'Songaree diabetes'
Intervention Description
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
Primary Outcome Measure Information:
Title
change in HbA1c of experimental group
Time Frame
6 months
Secondary Outcome Measure Information:
Title
No change in HbA1c of control group
Time Frame
6 months later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Months
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a. patients aged under 30 with type 1 diabetes b. patients who control glucose level with multiple daily injection of insulin pump c. Patients who agree the task to check glucose level during the experiment d. patients who has been diagnosed as type 1 diabetes more than 3 months e. patients whose A1c more than 8.0% within 6 months f. Patients who can use smartphone all day 2) exclusion criteria 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 Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ho-Seong Kim
Phone
82-2-2228-2050
Email
kimho@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho-Seong Kim
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho-Seong Kim
Phone
82-2-2228-2050
Email
kimho@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20723815
Citation
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.
Results Reference
result
PubMed Identifier
26912154
Citation
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.
Results Reference
result
PubMed Identifier
31862754
Citation
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.
Results Reference
result
PubMed Identifier
31862749
Citation
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.
Results Reference
result
PubMed Identifier
30175451
Citation
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.
Results Reference
result
PubMed Identifier
26888087
Citation
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.
Results Reference
result
PubMed Identifier
30026048
Citation
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.
Results Reference
result

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Effect of Smartphone Based Telemedicine and Education in Patients With Type 1 Diabetes Mellitus

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