UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042026 |
|---|---|
| Receipt number | R000047960 |
| Scientific Title | Interventional study for correlation analysis on food intake and glucose levels with continuous glucose monitoring (CGM) system in glycogen storage disease type Ia |
| Date of disclosure of the study information | 2020/10/06 |
| Last modified on | 2021/12/23 10:48:51 |
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Basic information
Public title
Interventional study for correlation analysis on food intake and glucose levels with continuous glucose monitoring (CGM) system in glycogen storage disease type Ia
Acronym
CGM study in glycogen storage disease type Ia
Scientific Title
Interventional study for correlation analysis on food intake and glucose levels with continuous glucose monitoring (CGM) system in glycogen storage disease type Ia
Scientific Title:Acronym
CGM study in glycogen storage disease type Ia
Region
| Japan |
Condition
Condition
glycogen storage disease type Ia
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients with Glycogen storage disease type Ia, to evaluate frequencies of hypoglycemia and the impact of dietary on interstitial fluid glucose levels
Basic objectives2
Others
Basic objectives -Others
In patients with Glycogen storage disease type Ia, to evaluate frequencies of hypoglycemia and the impact of dietary on interstitial fluid glucose levels
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of times interstitial fluid glucose levels is 4.0 mmol/ L or less during use of CGM per patient
Key secondary outcomes
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Measure interstitial fluid glucose levels using CGM for 14 days
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
| 2 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who have written informed consent by themselves or the legal representative
2. Patients who are 2 years or older
3. Patients diagnosed Glycogen storage disease type Ia by Genetic testing
Key exclusion criteria
1. Patients who are implanted pace maker
2. Patients after living donor liver transplantation
3. Females who are in pregnancy, breastfeeding
4. Patients whose participation in the trial was judged to be inappropriate by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tokiko |
| Middle name | |
| Last name | Fukuda |
Organization
Hamamatsu University School of Medicine
Division name
Department of Hamamatsu child health and development
Zip code
431-3192
Address
Handayama 1-20-1, Higashi ku, Hamamatsu City
TEL
053-435-2312
toki-fkd@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Wasaki |
Organization
DAIICHI SANKYO CO., LTD
Division name
Clinical Development 3
Zip code
140-8710
Address
1-2-58,hiromachi, Shinagawa-ku,Tokyo
TEL
03-3492-3131
Homepage URL
wasaki.yosuke.hi@daiichisankyo.co.jp
Sponsor or person
Institute
DAIICHI SANKYO CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO CO., LTD.
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
Hamamatsu University School of Medicine Clinical Research Ethics Committee
Address
1-20-1, Higashi-ku, Hamamatsu City
Tel
053-435-2680
rinri@hama-med.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
| 2020 | Year | 10 | Month | 06 | 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
32
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
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | 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
| 2020 | Year | 10 | Month | 06 | Day |
Last modified on
| 2021 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047960
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
