UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043517 |
|---|---|
| Receipt number | R000049680 |
| Scientific Title | A Clinical Interventional Study to Validate the Efficacy of Monitoring Blood Glucose, Diet, and Physical Activity in Diabetic Patients |
| Date of disclosure of the study information | 2022/09/30 |
| Last modified on | 2023/03/06 10:38:23 |
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Basic information
Public title
A Clinical Interventional Study to Validate the Efficacy of Monitoring Blood Glucose, Diet, and Physical Activity in Diabetic Patients
Acronym
A Study of the Efficacy of Combination Therapy for Monitoring Blood Glucose Levels and Lifestyle
Scientific Title
A Clinical Interventional Study to Validate the Efficacy of Monitoring Blood Glucose, Diet, and Physical Activity in Diabetic Patients
Scientific Title:Acronym
A Study of the Efficacy of Combination Therapy for Monitoring Blood Glucose Levels and Lifestyle
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A randomized clinical trial will be conducted to investigate the effectiveness of a combination therapy of flash glucose monitoring, the latest blood glucose monitoring system in diabetes care, and dietary and physical activity monitoring using Internet of Things.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
After obtaining consent, 40 diabetic patients who require lifestyle improvement for blood glucose control will be assigned to 1) FGM alone (FGM alone group) or 2) FGM plus lifestyle monitoring (FGM plus lifestyle monitoring group).
The degree of improvement in blood glucose control (Time In Range = percentage of target blood glucose of 70 mg/dl-180 mg/dl measured by FGM) after 3 months will be compared.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Glucose monitoring by FGM for 14 days will be performed every 5 weeks for a total of 3 times.During the post-monitoring visits, guidance will be given and medications will be changed as needed at the discretion of the attending physician.
Interventions/Control_2
Glucose monitoring by FGM for 14 days, physical activity measurement by physical activity meter for 14 days, and photographic dietary record for 3 days will be done every 5 weeks for a total of 3 times.
Instructions and medication changes will be made during post-monitoring visits.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Those with diabetes mellitus
2. Patients on insulin medication
3. Patients who can use the smartphone application "Think Health" (H2 Co., Ltd.)
4. Patients who are between 20 and 80 years old at the time of consent.
5. HbA1c 7.0% or higher, but less than 10.0%.
6.Patients with a BMI of more than 15 kg/m2 or less than 30 kg/m2.
7.Patients who have given written consent to participate in the study
Key exclusion criteria
1. Patients with food intake (excluding snacks) other than three times a day
2. Patients with anorexia nervosa
3. Patients with alcohol overdose
4. Patients who are deemed inappropriate by the physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Kitazawa |
Organization
Niigata University Faculty of Medicine
Department of Internal Medicine
Division name
Department of Community Medicine and Health
Zip code
9518510
Address
1-757 Asahimachi, Niigata, Niigata, Japan
TEL
+81253689026
mkitazawa-nii@umin.ac.jp
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Kitazawa |
Organization
Niigata University Faculty of Medicine Department of Internal Medicine
Division name
Department of Community Medicine and Health
Zip code
9518510
Address
1-757 Asahimachi, Niigata, Niigata, Japan
TEL
+81253689026
Homepage URL
mkitazawa-nii@umin.ac.jp
Sponsor or person
Institute
Niigata University Faculty of Medicine Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University Ethics Review Board
Address
1-757 Asahimachi, Niigata, Niigata, Japan
Tel
+81253689026
echics@med.niigata-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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | 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 | 03 | Month | 04 | Day |
Last modified on
| 2023 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049680
