UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039475 |
|---|---|
| Receipt number | R000044670 |
| Scientific Title | Prevalence and risk factors for impaired awareness hypoglycemia and severe hypoglycemia prevention study |
| Date of disclosure of the study information | 2020/02/13 |
| Last modified on | 2023/08/21 18:25:05 |
* 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
Prevalence and risk factors for impaired awareness hypoglycemia and severe hypoglycemia prevention study
Acronym
PR-IAH
Scientific Title
Prevalence and risk factors for impaired awareness hypoglycemia and severe hypoglycemia prevention study
Scientific Title:Acronym
PR-IAH
Region
| Japan |
Condition
Condition
Type 1 diabetes, type 2 diabetes with basal-bolus insulin therapy
Classification by specialty
| Endocrine surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the prevalence and risk factors of IAH
To investigate the effect of IAH on the incidence of severe hypoglycemia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severe hypoglycemia
Key secondary outcomes
Cardiovascular disease, diabetic complications, traffic accidents, dementia, bone fracture, atrial fibrillation
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1) type 1 diabetes, type 2 diabetes with basal-bolus insulin therapy
2) diabetes duration >=1years
3) >=20 years old
4) attending a collaborating centre
Key exclusion criteria
1) non-insulin therapy
2) anti-dementia drugs
3) inappropriate case judged by research director or research cordinators
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | NAOKI |
| Middle name | |
| Last name | SAKANE |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Clinical Research Institute
Zip code
612-8555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto, 612-8555 JAPAN
TEL
075-641-9161
404-j-doit1@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | AKIKO |
| Middle name | |
| Last name | SUGANUMA |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Clinical Research Institute
Zip code
612-8555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto, 612-8555 JAPAN
TEL
075-641-9161
Homepage URL
404-j-doit1@mail.hosp.go.jp
Sponsor or person
Institute
Natiional Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization
Address
2-5-21Higashigaoka Meguro-kuToukyou-to
Tel
03-5712-5050
700-kenkyu@mail.hosp.go.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 | 02 | Month | 13 | 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
344
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
Main results already published
Date of protocol fixation
| 2020 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Gold,Clarks,Pedersen-Bjergaard method
Management information
Registered date
| 2020 | Year | 02 | Month | 13 | Day |
Last modified on
| 2023 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044670
