UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046257 |
|---|---|
| Receipt number | R000052731 |
| Scientific Title | Effects of mobile health usage in Japanese patients with diabetes receiving insulin/GLP-1 receptor agonist: Randomized controlled trial (mHealth-DM-insulin/GLP-1RA) |
| Date of disclosure of the study information | 2021/12/02 |
| Last modified on | 2022/09/16 06:49:00 |
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Basic information
Public title
Effects of mobile health usage in Japanese patients diabetes receiving insulin/GLP-1 receptor agonist: Randomized controlled trial (mHealth-DM-insulin/GLP-1RA)
Acronym
Effects of mHealth in Japanese DM on insulin/GLP-1 receptor agonist (mHealth-insulin/GLP-1RA)
Scientific Title
Effects of mobile health usage in Japanese patients with diabetes receiving insulin/GLP-1 receptor agonist: Randomized controlled trial (mHealth-DM-insulin/GLP-1RA)
Scientific Title:Acronym
Effects of mHealth in Japanese DM on insulin/GLP-1 receptor agonist (mHealth-DM-insulin/GLP-1RA)
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the impact of use of mobile health on HbA1c, weight management and QOL for diabetic patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in HbA1c after 6 months use of mHealth
Key secondary outcomes
Changes in weight, HDL-c, LDL-c, TG, self-injection adherence, DTR-QOL, SDSCA, FFQ, App usage continuation rate and hypoglycemia frequency after usage of mHealth for 6 months
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Incorporate mHealth into the usual treatment for 6 months
Interventions/Control_2
Perform regular medical care for 6 months
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients who meets all conditions follows:
1) Diabetic patients using SMBG over 3 months who have used self-injecting insulin, GLP-1 receptor agonists, or both
2) Smarat phone users over 6 months
3) Patients who the attending physician has determined to be able to answer various questionnaires
4) Age 20 or over, under 75
5) HbA1c 7.0% or over, under 11.0% (under 65 years old), 7.5% or over (Age 65 or over, under 75 years old)
6) BMI 18 or more, less than 35
Key exclusion criteria
The patients who meets any of the conditions follows:
1) Patients suspected of having dementia or mental disease
2) Patients with serious liver or kidney disease
3) Hb under 10 g/dL
4) Patients who undergo surgical resection or chemotherapy for malignant neoplasms or who have performed it within the past 5 years
5 Patients who use steroids as therapeutic agents (excluding inhalation or intment)
6) Patients who are judged to be inappropriate for this research
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Yabe |
Organization
Gifu University Hospital
Division name
Division of Diabetes, Endocrinology and Metabolism, Division of Rheumatology and Clinical Immunology
Zip code
501-1194
Address
1-1 Yanagido, Gifu 501-1194, Japan
TEL
058-230-6377
ydaisuke-kyoto@umin.ac.jp
Public contact
Name of contact person
| 1st name | Makie |
| Middle name | |
| Last name | Honda |
Organization
Gifu University Hospital
Division name
Division of Diabetes, Endocrinology and Metabolism, Division of Rheumatology and Clinical Immunology
Zip code
501-1194
Address
1-1 Yanagido, Gifu 501-1194, Japan
TEL
058-230-6377
Homepage URL
komanyan66@gmail.com
Sponsor or person
Institute
Gifu University Hospital
Institute
Department
Personal name
Funding Source
Organization
H2.Inc
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Central ethics committee of Gifu University
Address
/1-1 Yanagido, Gifu 501-1194, Japan
Tel
+81582306000
rinri@gifu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
松波総合病院
岐阜県総合医療センター
岐阜市民病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 02 | Day |
Last modified on
| 2022 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052731
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