Clinical trial NCT04721509: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Diabetes Mellitus, Telemedicine, Smartphone, Type 1, Child, Adolescent, Young Adult
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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


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

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:

-

Primary outcomes:
measure: change in HbA1c of experimental group
timeFrame: 6 months
Secondary outcomes:
measure: No change in HbA1c of control group
timeFrame: 6 months later
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
affiliation: Severance Hospital
name: Ho-Seong Kim
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.
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.
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.