UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034162 |
|---|---|
| Receipt number | R000038946 |
| Scientific Title | Comparison of accuracy between iPro2 and LibrePro in patients on hemodialysis |
| Date of disclosure of the study information | 2018/09/15 |
| Last modified on | 2020/11/12 18:10:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of accuracy between iPro2 and LibrePro in patients on hemodialysis
Acronym
Comparison between iPro2 and LibrePro in hemodialysis
Scientific Title
Comparison of accuracy between iPro2 and LibrePro in patients on hemodialysis
Scientific Title:Acronym
Comparison between iPro2 and LibrePro in hemodialysis
Region
| Japan |
Condition
Condition
Patients on hemodialysis with/without diabetes
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of accuracy between iPro2 and LibrePro in patients on hemodialysis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MARD(Mean Absolute Relative Difference)
Sensor glucose data
Key secondary outcomes
Relationship between sensor glucose data and diabetic markers
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Wearing 2 kinds of continuous glucose monitoring
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients on hemodialysis agreed to this study
Key exclusion criteria
Subjects disagreed to this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Hayashi |
Organization
Kitasato University School of Medicine
Division name
Endocrinology, Diabetes and Metabolism
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara
TEL
0427788111
ahayashi@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Hayashi |
Organization
Kitasato University School of Medicine
Division name
Endocrinology, Diabetes and Metabolism
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara
TEL
0427788111
Homepage URL
ahayashi@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Medical Ethics Organization, KMEO
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
Tel
0427788111
rinrib@med.kitasato-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
| 2018 | Year | 09 | Month | 15 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S1056872720304426?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S1056872720304426?via%3Dihub
Number of participants that the trial has enrolled
13
Results
Overall, FGM and CGM were 95.4% and 98.9% within the Zone A+B of Parks Error Grid.
During HD, FGM and CGM were 86.9% and 95.0% within the Zone A+B.
The MARD for FGM was significantly higher than that for CGM.
Results date posted
| 2020 | Year | 11 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 07 | Month | 18 | Day |
Baseline Characteristics
Simultaneous FGM (FreeStyle LibrePro), CGM (iPro2) and SMBG were performed on 13 T2D research subjects.
Participant flow
Simultaneous FGM (FreeStyle LibrePro), CGM (iPro2) and SMBG were performed on 13 T2D research subjects.
Adverse events
The only adverse events identified during the entire study period were minor skin troubles in two patients, skin redness and slight skin itchy on the site of FGM, and dropped-off FGM in only one patient.
Outcome measures
There were good overall correlations between SMBG and FGM (64.7% and 30.8% within the A and B of Parkes Error Grid, respectively) and between SMBG and CGM (87.9% and 11.0% within the A and B, respectively). However, during HD, correlations between SMBG and FGM were only 49.7% and 37.2% within the A and B, respectively, while correlations of SMBG and CGM were 72.8% and 22.2% within the A and B, respectively. The percentage of FGM not in Zone A + B was more than 4 times higher than for CGM. The overall mean absolute relative difference (MARD) for FGM was 18.2%, this significantly higher than 11.2% for CGM. During HD, MARD for FGM was 22.8%, significantly higher than 15.0% for CGM.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 17 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 17 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 15 | Day |
Last modified on
| 2020 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038946
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
