UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029842
Receipt number R000034087
Scientific Title Efficacy, effect of hypoglycemia, assessment of QOL to use FreeStyle Libre Flash Glucose Monitoring System in type 2 diabetis
Date of disclosure of the study information 2017/11/06
Last modified on 2020/01/10 14:24:02

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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 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 or person

Institute

Medical Corporation H.E.C Science Clinic

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034087


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name