UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy, effect of hypoglycemia, assessment of QOL to use FreeStyle Libre Flash Glucose Monitoring System in type 2 diabetis
Acronym	Efficacy, effect of hypoglycemia, assessment of QOL to use FreeStyle Libre Flash Glucose Monitoring System in type 2 diabetis
Scientific Title	Efficacy, effect of hypoglycemia, assessment of QOL to use FreeStyle Libre Flash Glucose Monitoring System in type 2 diabetis
Scientific Title:Acronym	Efficacy, effect of hypoglycemia, assessment of QOL to use FreeStyle Libre Flash Glucose Monitoring System in type 2 diabetis
Region	Japan

Condition
Condition	Type2 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 2 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 3 months, for the following measures With the date from snapshot through FreeStyle Libre softwear, average sensor glucose, time in range(setting sensor glucose 70-180mg/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 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 2 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 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 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 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
Email	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
Email	hec@asahi-net.email.ne.jp

Sponsor
Institute	Medical Corporation H.E.C Science Clinic
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
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
Email	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(for 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 data (for 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034087