UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037782
Receipt number R000043075
Scientific Title Flash glucose monitoring in elderly diabetic patients at home Usefulness of blood glucose trend analysis and specialist intervention
Date of disclosure of the study information 2019/08/26
Last modified on 2023/08/30 11:28:40

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Basic information

Public title

Usefulness of blood glucose control using Flash Glucose Monitoring in patients with diabetes at home

Acronym

FGM at home

Scientific Title

Flash glucose monitoring in elderly diabetic patients at home Usefulness of blood glucose trend analysis and specialist intervention

Scientific Title:Acronym

Usefulness of FGM in elderly diabetic patients at home

Region

Japan


Condition

Condition

Diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effectiveness of Flash Glucose Monitoring, a non-insurance continuous blood glucose measurement system for home patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Evaluation of blood glucose monitor operation using continuous glucose monitoring systems in home medical care

Key secondary outcomes

1.Identification of hypoglycemia events by CGMS
2.Treatment intervention by specialists based on CGMS analysis results and reduction in the number of hypoglycemic events
3.Safety assessment of CGM device puncture procedure by visiting nurses
4.Life improvement effect by dietitian intervention based on CGMS analysis results
5.Improvement of QOL that can be obtained from home patients by blood glucose monitoring by CGMS
6.Problems of home diabetes management revealed by CGMS


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Equipped with Flash Glucose Monitoring up to 14 days. Analyze the data and then devise treatment by a specialist. After a sufficient period of time, FGM will be applied again and post-analysis will be conducted to assess efficacy.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patients who are undergoing home visits and have Diabetes (regardless of disease type)registered as the disease name.
2.Preferentially select patients who are receiving diabetes treatment (insulin, SU, etc.) that are likely to induce hypoglycemia
3.During the visit, Libre pro sensor was attached and collected, and subsequent data analysis and treatment intervention by diabetes specialists and medical instructors were accepted.
4.Patients who can cooperate in filling out the check sheet (using DTR-QOL) on health management QOL by the patient or family.

Key exclusion criteria

1.Patients with other electronic devices such as pacemakers.
2.Patients who are scheduled to undergo imaging examinations such as X-ray and MRI within one month
3.Other patients who are determined to be unsuitable for conducting this study safely by the principal investigator or doctor in charge.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Takuya
Middle name
Last name Watanabe

Organization

Saku central hospital advanced care center

Division name

Endocrinology and metabolism

Zip code

385-0051

Address

Nakagomi, Saku-shi, Nagano 385-0051, Japan

TEL

0267-82-8181

Email

takuyaw.yks@gmail.com


Public contact

Name of contact person

1st name Takuya
Middle name
Last name Watanabe

Organization

Saku central hospital advanced care center

Division name

Endocrinology and metabolism

Zip code

385-0051

Address

Nakagomi, Saku-shi, Nagano 385-0051, Japan

TEL

0267-82-8181

Homepage URL


Email

takuyaw.yks@gmail.com


Sponsor or person

Institute

Saku central hospital advanced care center
department of endocrinology and metabolism

Institute

Department

Personal name



Funding Source

Organization

Nothing

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

Saku Central Hospital Group Research Ethics Committee

Address

197 Usuda, Saku, 384-0301 JAPAN

Tel

0267-82-3131

Email

ctroffice@sakuhp.or.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

2019 Year 08 Month 26 Day


Related information

URL releasing protocol

nothing

Publication of results

Unpublished


Result

URL related to results and publications

nothing

Number of participants that the trial has enrolled

0

Results

Not found

Results date posted

2019 Year 08 Month 23 Day

Results Delayed

Delay expected

Results Delay Reason

Now proceeding

Date of the first journal publication of results


Baseline Characteristics

Nothing

Participant flow

Nothing

Adverse events

Nothing

Outcome measures

Nothing

Plan to share IPD

Nothing

IPD sharing Plan description

Nothing


Progress

Recruitment status

Terminated

Date of protocol fixation

2018 Year 08 Month 04 Day

Date of IRB

2018 Year 08 Month 04 Day

Anticipated trial start date

2018 Year 08 Month 04 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry

2023 Year 12 Month 31 Day

Date trial data considered complete

2023 Year 12 Month 31 Day

Date analysis concluded

2023 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 08 Month 23 Day

Last modified on

2023 Year 08 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043075


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name