UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026452 |
|---|---|
| Receipt number | R000030387 |
| Scientific Title | Study of the impact of the Flash Glucose Monitoring System(FGM) on glycometabolism of type 2 diabetic patients |
| Date of disclosure of the study information | 2017/03/10 |
| Last modified on | 2024/03/12 14:07:33 |
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Basic information
Public title
Study of the impact of the Flash Glucose Monitoring System(FGM) on glycometabolism of type 2 diabetic patients
Acronym
Study of the impact of the Flash Glucose Monitoring System(FGM) on glycometabolism of type 2 diabetic patients
Scientific Title
Study of the impact of the Flash Glucose Monitoring System(FGM) on glycometabolism of type 2 diabetic patients
Scientific Title:Acronym
Study of the impact of the Flash Glucose Monitoring System(FGM) on glycometabolism of type 2 diabetic patients
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effects of the Flash Glucose Monitoring System(FGM) on glycometabolism of type 2 diabetic patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c
Key secondary outcomes
glucose cariability
patient satisfaction
blood pressure
body weight
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Encourage to improve life style by using Flash glucose monitoring system(FGM)
Interventions/Control_2
Encourage to improve life style by using conventional device for self measurement of blood glucose(SMBG)
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes mellitus
HbA1c 7.5% or more and less than 8.5%
Key exclusion criteria
Diabetic nephropathy (eGFR<30ml/min/1.73m2)
Dialysis patient
Receiving insulin therapy
Proliferative diabetic retinopathy or preproliferative retinopathy
Subjects who can not properly operate the device to be used
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Arima |
Organization
Nagoya University Graduate School of Medicine
Division name
Endocrinology and Diabetes
Zip code
466-8550
Address
65 Tsurumai-Cho,Showa-ku,Nagoya,Japan
TEL
052-744-2142
arima105@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Motomitsu |
| Middle name | |
| Last name | Goto |
Organization
Nagoya University Graduate School of Medicine
Division name
Endocrinology and Diabetes
Zip code
466-8550
Address
65 Tsurumai-Cho,Showa-ku,Nagoya,Japan
TEL
052-744-2142
Homepage URL
goto@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Unsettled
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethical Committee of the Nagoya University Hospital
Address
65 tsurumai-cho, showa-ku, Nagoya, Aichi
Tel
052-744-2973
ethics@med.nagoya-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
| 2017 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
https://drc.bmj.com/content/bmjdrc/8/1/e001115.full.pdf
Publication of results
Partially published
Result
URL related to results and publications
https://drc.bmj.com/content/bmjdrc/8/1/e001115.full.pdf
Number of participants that the trial has enrolled
100
Results
The mean HbA1c levels were 7.83% in the FGM group and 7.84% in the SMBG group at baseline, and the values were reduced in both FGM (-0.43%) and SMBG groups (-0.30%) at 12 weeks. On the other hand, HbA1c was significantly decreased from baseline values in the FGM group, but not in the SMBG group at 24 weeks (FGM, -0.46% SMBG, -0.17%);a significant between-group difference was also observed (difference -0.29%).
Results date posted
| 2020 | Year | 09 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with non-insulin-treated type 2 diabetes at five hospitals in Japan were eligible for inclusion if they HbA1c more than or equal to 7.5% (59 mmol/mol) and <8.5% (69 mmol/mol).
Participant flow
Patients were randomly assigned to the FGM (n=49) or SMBG (n=51) groups and were provided each device for 12 weeks.
Adverse events
None of the severe adverse events was related to the device or study procedure.
Outcome measures
The primary outcome was change in glycated hemoglobin (HbA1c) level.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 07 | Day |
Last modified on
| 2024 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030387
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