UMIN-CTR Clinical Trial

Public title

Investigating the effect of psychological behavior modification by performing blood glucose self-care using Flash glucose monitoring at diabetes treatment commencement

Acronym

Investigating the effect of psychological behavior modification by performing blood glucose self-care using Flash glucose monitoring at diabetes treatment commencement

Scientific Title

Investigating the effect of psychological behavior modification by performing blood glucose self-care using Flash glucose monitoring at diabetes treatment commencement

Scientific Title:Acronym

Investigating the effect of psychological behavior modification by performing blood glucose self-care using Flash glucose monitoring at diabetes treatment commencement

Region

Japan

Condition

Type2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We carried out a 12-month evaluation of the psychological changes and clinical changes experienced by patients with short-term Libre use at the beginning of their treatment and patients who received conventional treatment without Libre use; furthermore, we examined more adequate usages of Libre.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

4 questionnaire surveys were conducted during the treatment monitoring period at 1 month, at 3 months, at 6 month and at 12 months. Feelings regarding diabetes treatment were evaluated and categorized based on 10 different levels, Lifestyle changes were evaluated and categorized based on 5 different levels, Diabetes Treatment Satisfaction Questionnaire was evaluated and categorized based on 7 different levels, and Problem Areas In Diabetes were evaluated and categorized based on 5 different levels.

Key secondary outcomes

We follow up continuously during a 12 months treatment period. Comparisons were carried out based on BMI, blood pressure, HbA1c, PG, LDLC, HDLC, TG, AST, ALT, GGTP, eGFR.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

15 patients who voluntarily requested to wear FGM [Libre] for 2 to 4 weeks at the beginning of treatment.

Interventions/Control_2

15 patients who voluntarily requested to wear non FGM [Libre] at the beginning of treatment.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

The patients who had type2 diabetes mellitus pointed out for the first time over 20 year old
(untreated at registration).

Key exclusion criteria

Insulin-dependent patients.
The patients who have had diabetes pointed out in the past.

Target sample size

36

Name of lead principal investigator

1st name	Shuichi
Middle name
Last name	Sato

Organization

Futata Tetsuhiro Clinic

Division name

Department of Internal Medicine, Endocrinology, Metabolism and Diabetes

Zip code

810-0001

Address

7F, Tenjin Futata Building, 3-1-1 Tenjin, Chuo-ku, Fukuoka City, Fukuoka, Japan

TEL

092-738-1230

Email

s.sato@futata-cl.jp

Name of contact person

1st name	Shuichi
Middle name
Last name	Sato

Organization

Futata Tetsuhiro Clinic

Division name

Department of Internal Medicine, Endocrinology, Metabolism and Diabetes

Zip code

810-0001

Address

7F, Tenjin Futata Building, 3-1-1 Tenjin, Chuo-ku, Fukuoka City, Fukuoka, Japan

TEL

092-738-1230

Homepage URL

Email

s.sato@futata-cl.jp

Institute

Futata Tetsuhiro Clinic

Institute

Department

Personal name

Organization

Futata Tetsuhiro Clinic

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Japan Association for Diabetes Education and Care

Address

8F, Central Building, 2-2-4 Kojimachi, Chiyoda-ku, Tokyo, Japan

Tel

03-3514-1721

Email

rinri@nittokyo.or.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

二田哲博クリニック（福岡県）

Date of disclosure of the study information

2019

Year

12

Month

31

Day

URL releasing protocol

https://www.pieronline.jp/content/article/0289-8020/41070/577

Publication of results

Published

URL related to results and publications

https://www.pieronline.jp/content/article/0289-8020/41070/577

Number of participants that the trial has enrolled

30

Results

DTSQ showed an increasing trend in group B from 25.5 to 30.3.On the other hand, group A had a high value of 34.0 at the start, but after 12 months, the difference of 2 groups was disappeared.
After 12 months, PAID was decreased from 62.3 to 54.6 in group B, while it was increased from 34.0 to 54.6 in group A. Finally the difference of two groups was disappeared.
There was significant difference in changing of DTSQ between 2 groups .

Results date posted

2019

Year

05

Month

05

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2020

Year

06

Month

08

Day

Baseline Characteristics

The patients who had type2 diabetes mellitus pointed out for the first time over 20 year old
(untreated at registration).

Participant flow

https://www.pieronline.jp/content/article/0289-8020/41070/577

Adverse events

none

Outcome measures

We were able to follow up continuously during a 12 months treatment period, were assigned to two different groups: the A group (15 patients who voluntarily requested to wear FGM for 2 to 4 weeks at the beginning of treatment) and B group (15 patients who requested to receive conventional treatment without using FGM); comparisons were carried out based on BMI, blood pressure, HbA1c, PG, LDL-C, HDL-C, TG, AST, ALT, GGTP, Cr (eGFR)
4 questionnaire surveys were conducted during the treatment monitoring period (at 1 month, at 3 months, at 6 months, at 12 months); (1)feelings regarding diabetes treatment were evaluated and categorized based on 10 different levels, (2) lifestyle changes were evaluated and categorized based on 5 different levels, (3) patient satisfaction with diabetes treatment (Diabetes Treatment Satisfaction Questionnaire) was evaluated and categorized based on 7 different levels, and (4) psychological burdens associated with diabetes (Problem Areas In Diabetes)were evaluated and categorized based on 5 different levels.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2017

Year

10

Month

01

Day

Date of IRB

2019

Year

01

Month

31

Day

Anticipated trial start date

2019

Year

01

Month

31

Day

Last follow-up date

2020

Year

04

Month

18

Day

Date of closure to data entry

2020

Year

04

Month

18

Day

Date trial data considered complete

2020

Year

04

Month

18

Day

Date analysis concluded

2020

Year

04

Month

18

Day

Other related information

Registered date

2019

Year

05

Month

09

Day

Last modified on

2023

Year

11

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041653