UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026452
Receipt number R000030387
Scientific Title Study of the impact of the Flash Glucose Monitoring System(FGM) on glycometabolism of type 2 diabetic patients
Date of disclosure of the study information 2017/03/10
Last modified on 2024/03/12 14:07:33

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Basic information

Public title

Study of the impact of the Flash Glucose Monitoring System(FGM) on glycometabolism of type 2 diabetic patients

Acronym

Study of the impact of the Flash Glucose Monitoring System(FGM) on glycometabolism of type 2 diabetic patients

Scientific Title

Study of the impact of the Flash Glucose Monitoring System(FGM) on glycometabolism of type 2 diabetic patients

Scientific Title:Acronym

Study of the impact of the Flash Glucose Monitoring System(FGM) on glycometabolism of type 2 diabetic patients

Region

Japan


Condition

Condition

Type 2 Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To explore the effects of the Flash Glucose Monitoring System(FGM) on glycometabolism of type 2 diabetic patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

HbA1c

Key secondary outcomes

glucose cariability
patient satisfaction
blood pressure
body weight


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Encourage to improve life style by using Flash glucose monitoring system(FGM)

Interventions/Control_2

Encourage to improve life style by using conventional device for self measurement of blood glucose(SMBG)

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

Type 2 diabetes mellitus
HbA1c 7.5% or more and less than 8.5%

Key exclusion criteria

Diabetic nephropathy (eGFR<30ml/min/1.73m2)
Dialysis patient
Receiving insulin therapy
Proliferative diabetic retinopathy or preproliferative retinopathy
Subjects who can not properly operate the device to be used

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Arima

Organization

Nagoya University Graduate School of Medicine

Division name

Endocrinology and Diabetes

Zip code

466-8550

Address

65 Tsurumai-Cho,Showa-ku,Nagoya,Japan

TEL

052-744-2142

Email

arima105@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Motomitsu
Middle name
Last name Goto

Organization

Nagoya University Graduate School of Medicine

Division name

Endocrinology and Diabetes

Zip code

466-8550

Address

65 Tsurumai-Cho,Showa-ku,Nagoya,Japan

TEL

052-744-2142

Homepage URL


Email

goto@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University

Institute

Department

Personal name



Funding Source

Organization

Unsettled

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

the Ethical Committee of the Nagoya University Hospital

Address

65 tsurumai-cho, showa-ku, Nagoya, Aichi

Tel

052-744-2973

Email

ethics@med.nagoya-u.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

2017 Year 03 Month 10 Day


Related information

URL releasing protocol

https://drc.bmj.com/content/bmjdrc/8/1/e001115.full.pdf

Publication of results

Partially published


Result

URL related to results and publications

https://drc.bmj.com/content/bmjdrc/8/1/e001115.full.pdf

Number of participants that the trial has enrolled

100

Results

The mean HbA1c levels were 7.83% in the FGM group and 7.84% in the SMBG group at baseline, and the values were reduced in both FGM (-0.43%) and SMBG groups (-0.30%) at 12 weeks. On the other hand, HbA1c was significantly decreased from baseline values in the FGM group, but not in the SMBG group at 24 weeks (FGM, -0.46% SMBG, -0.17%);a significant between-group difference was also observed (difference -0.29%).

Results date posted

2020 Year 09 Month 12 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients with non-insulin-treated type 2 diabetes at five hospitals in Japan were eligible for inclusion if they HbA1c more than or equal to 7.5% (59 mmol/mol) and <8.5% (69 mmol/mol).

Participant flow

Patients were randomly assigned to the FGM (n=49) or SMBG (n=51) groups and were provided each device for 12 weeks.

Adverse events

None of the severe adverse events was related to the device or study procedure.

Outcome measures

The primary outcome was change in glycated hemoglobin (HbA1c) level.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 03 Month 10 Day

Date of IRB

2017 Year 06 Month 20 Day

Anticipated trial start date

2017 Year 06 Month 20 Day

Last follow-up date

2019 Year 05 Month 18 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 03 Month 07 Day

Last modified on

2024 Year 03 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030387


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name