UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029837 |
|---|---|
| Receipt number | R000034038 |
| Scientific Title | Efficacy, effect of hypoglycemia, assessment of QOL to use FreeStyle Libre Flash Glucose Monitoring System in type 1 diabetis |
| Date of disclosure of the study information | 2017/11/06 |
| Last modified on | 2020/01/10 14:22:20 |
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Basic information
Public title
Efficacy, effect of hypoglycemia, assessment of QOL to use FreeStyle Libre Flash Glucose Monitoring System in type 1 diabetis
Acronym
Efficacy, effect of hypoglycemia, assessment of QOL to use FreeStyle Libre Flash Glucose Monitoring System in type 1 diabetis
Scientific Title
Efficacy, effect of hypoglycemia, assessment of QOL to use FreeStyle Libre Flash Glucose Monitoring System in type 1 diabetis
Scientific Title:Acronym
Efficacy, effect of hypoglycemia, assessment of QOL to use FreeStyle Libre Flash Glucose Monitoring System in type 1 diabetis
Region
| Japan |
Condition
Condition
Type1 diabetes using insulin
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop efficacy, effect of hypoglycemia, assessment of QOL using FreeStyle Libre Flash Glucose Monitoring System in type 1 diabetis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from Baseline in HbA1c and bodyweight at 3 months
Key secondary outcomes
Change for 2 weeks between at baseline and at 3months, for the following measures
With the date from snapshot through FreeStyle Libre softwear, average sensor glucose, time in range (setting sensor glucose70-180mg/dl in target), the percentage above, below, and in target,
number and duration of hypoglycemic episodes.
QOL questionnaire.
Bodyweight and BMI
Number of Sensor scans performed.
Relationships between the blood glucose and sensor glucose
Bolas insulin dose and basal insulin dose
In cases of discontinuation, examination of the reason for discontinuation and the occurrence of adverse events.
Comparison of a continued group and a discontinued group.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Out patients(type 1 diabetes) who receive insulin therapy and monitor their blood glucose level with conventional blood glucose meters >=6 months.
Patients who give written informed consent to participate in the study
In the investigator's opinion, the subject is technically capable of using device. In the investigator's opinion, the subject is proactive and therefore willing to modify their diabetes management.
Key exclusion criteria
Currently receiving dialysis treatment or planning to receive dialysis during the trial.
A female subject who is pregnant or planning to become pregnant within the trial duration.
Has a pacemaker or any other neurostimulators.
In the treatment for diabetes, patients who will be able to receive benefits by using Free Style Libre Flash Glucose Monitoring System and hope to use it patients themselves.
In the investigator's opinion, the subject is unsuitable to participate due to any other cause/reason.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Maeda |
Organization
Medical Corporation
H.E.C Science Clinic
Division name
Diabetes internal medicine
Zip code
235-0045
Address
4-1-4-102 Youkoudai Isogo-ku Yokohama-city Kanagawa-ken Japan
TEL
045-831-0031
hec@asahi-net.email.ne.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Makuuchi |
Organization
Medical Corporation H.E.C Science Clinic
Division name
Clinical Trial Secretariat
Zip code
235-0045
Address
4-1-4-102 Youkoudai Isogo-ku Yokohama-city Kanagawa-ken Japan
TEL
045-831-0031
Homepage URL
hec@asahi-net.email.ne.jp
Sponsor or person
Institute
Medical Corporation H.E.C Science Clinic
Institute
Department
Personal name
Funding Source
Organization
none
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
Ethics review committee of Medical Corporation H.E.C Science Clinic
Address
4-1-4-102 Youkoudai Isogo-ku Yokohama-city Kanagawa-ken Japan
Tel
045-831-0031
hec-soum@asahi-net.emai.ne.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
医療法人社団一洋会H.E.Cサイエンスクリニック（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | 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
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
| 2017 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Baseline phase (2 weeks) = wear of the FreeStyle Libre Flash Glucose Monitoring System .Sensor glucose and blood Glucose measurements to be performed using the FreeStyle Libre Flash Glucose Monitoring System
Visit 2 (Day 30): Start of Baseline phase Data(2weeks) upload and safety monitoring check-up
Visit 3 (Day 60): Data upload and safety monitoring check-up
Visit 4 (Day 90): Data upload and safety monitoring check-up
Visit 5 (Day 120): Final visit
Final phase date(2weeks) upload and safety monitoring check-up
3.5 months per subject,; total expected duration of up to 4months per subject.
Management information
Registered date
| 2017 | Year | 11 | Month | 06 | Day |
Last modified on
| 2020 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034038
