UMIN-CTR Clinical Trial

Public title

The Effect of colored self-monitoring of blood glucose (SMBG) in type 2 diabetic patients: randomized controlled trial

Acronym

Color IMPACT Study

Scientific Title

The Effect of colored self-monitoring of blood glucose (SMBG) in type 2 diabetic patients: randomized controlled trial

Scientific Title:Acronym

Color IMPACT Study

Region

Japan

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Nursing

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effect of color-indicated blood glucose levels on HbA1c and self-management performance in type 2 diabetic patients with SMBG

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Change in HbA1c level from baseline to 6 months after intervention

Key secondary outcomes

A) difference in changes in score of the following questionnaires;
1) Instrument of Diabetes Self-Care Agency(IDSCA)
2) The Summary of Diabetes Self-Care Activities Measure(SDSCA)
3) abridged version of Profile of Mood States(POMS)
B) ratio of the following dates;
4) occurrence of change in the dosage and type of insulin/GLP-1 receptor agonist
5) dropout by the discontinuing insulin/GLP-1 receptor agonist treatment or hospitalization
C) 6) change in continuance rate of SMBG
D) differences in changes in the following levels from baseline to 1 and 2 years;
7) HbA1c levels
8) blood pressure
9) low-density lipoprotein cholesterol levels
10) body weight

Study type

Interventional

Basic design

Factorial

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Standard SMBG (Control)

Interventions/Control_2

Using a blood glucose meter with color display indicating blood glucose level in color code

Interventions/Control_3

Marking color circles on their SMBG record in case of hyperglycemia and hypoglycemia

Interventions/Control_4

Combination approach of using a blood glucose meter with color display(intervention 2) and marking color circles(intervention 3)

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

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Outpatients with T2DM who have been treated with insulin or GLP-1 receptor agonist and perform SMBG
2) Subjects between 20 and 80 years old
3) HbA1c value is over 6.5% and under 10.0%(JDS)
4) Subjects who can diet and/or exercise
5) Subjects who can give written consent

Key exclusion criteria

1) Subjects under 20 years old and over 81
2) Diabetes duration less than 1 year
3) Subjects who initiated treatment with insulin or GLP-1 receptor agonist, or changed the type of insulin or GLP-1 receptor agonist within the last 4 months
4) Subjects who cannot do SMBG by themselves
5) Subjects with impaired vision or synesthesia
6) Subjects who have difficulty with comprehension, psychiatric disease or procedural problems
7) Subjects who have severe heart, hepatic or renal disease
8) Subjects who have abnormal hemoglobin
9) Subjects who are scheduled for hospitalization or move within 6 months
10) Subjects who are not permitted to participate in this trial by attending doctors

Target sample size

240

Name of lead principal investigator

1st name
Middle name
Last name	Nobuya, INAGAKI

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Diabetes, Endcrinoogy and Nutrition

Zip code

Address

Shogoin Kawahara-cho 54, Sakyo-ku, Kyoto-city, Kyoto, Japan

TEL

075-751-3560

Email

inagaki@metab.kuhp.kyoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Akiko, NISHIMURA

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Human Health Sciences

Zip code

Address

Shogoin Kawahara-cho 53, Sakyo-ku, Kyoto-city, Kyoto, Japan

TEL

075-751-3927

Homepage URL

Email

cimpact-group@umin.ac.jp

Institute

Kyoto University

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

京都大学医学部附属病院（京都府）

Date of disclosure of the study information

2012

Year

01

Month

01

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

11

Month

17

Day

Date of IRB

Anticipated trial start date

2012

Year

02

Month

01

Day

Last follow-up date

2014

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

12

Month

09

Day

Last modified on

2017

Year

02

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008110