UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046200
Receipt number R000052723
Scientific Title Study of Glycemic Variability, Hypoglycemia Using Continuous Glucose Monitoring in Type 2 Diabetes Mellitus Changed from Basal-Bolus Therapy to Basal-GLP-1 RA Therapy
Date of disclosure of the study information 2021/12/01
Last modified on 2021/11/26 18:40:35

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Basic information

Public title

Study of Glycemic Variability, Hypoglycemia Using Continuous Glucose Monitoring in Type 2 Diabetes Mellitus Changed from Basal-Bolus Therapy to Basal-GLP-1 RA Therapy

Acronym

From BBT To BGT Study in T2DM

Scientific Title

Study of Glycemic Variability, Hypoglycemia Using Continuous Glucose Monitoring in Type 2 Diabetes Mellitus Changed from Basal-Bolus Therapy to Basal-GLP-1 RA Therapy

Scientific Title:Acronym

From BBT To BGT Study in T2DM

Region

Japan


Condition

Condition

Type 2 Diabetes Mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In patients with T2D treated with Basal-Bolus Therapy (BBT) using a small amount of bolus insulin and stable glycemic control, under CGM, we had left basal insulin and switched from all bolus insulin to a weekly GLP-1 RA.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in HbA1c and patient satisfaction immediately before switching from BBT to BGT and 1 month after switching

Key secondary outcomes



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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Type 2 diabetic patients who are receiving multiple daily insulin injection therapy, have HbA1c or fasting blood glucose / postplandial blood glucose levels within the control target, and have insulin endocrine ability remaining.

Key exclusion criteria

Diabetic patients with poor glycemic control due to multiple daily insulin injection therapy

Target sample size

25


Research contact person

Name of lead principal investigator

1st name Arina
Middle name
Last name Miyoshi

Organization

Sapporo City General Hospital

Division name

Department of Diabetes and Endocrinology

Zip code

0608604

Address

Kita 11, Nishi 13, Chuo-ku, Sapporo, 060-8604, Japan

TEL

0117262211

Email

a.miyoshi@hotmail.co.jp


Public contact

Name of contact person

1st name Arina
Middle name
Last name Miyoshi

Organization

Sapporo City General Hospital

Division name

Department of Diabetes and Endocrinology

Zip code

0608604

Address

Kita 11, Nishi 13, Chuo-ku, Sapporo, 060-8604, Japan

TEL

0117262211

Homepage URL


Email

a.miyoshi@hotmail.co.jp


Sponsor or person

Institute

Sapporo City General Hospital

Institute

Department

Personal name



Funding Source

Organization

none

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

Sapporo City General Hospital

Address

Kita 11, Nishi 13, Chuo-ku, Sapporo, 060-8604, Japan

Tel

0117262211

Email

a.miyoshi@hotmail.co.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

2021 Year 12 Month 01 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

25

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

2019 Year 04 Month 08 Day

Date of IRB

2019 Year 04 Month 19 Day

Anticipated trial start date

2019 Year 05 Month 01 Day

Last follow-up date

2021 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

preparation of a manuscript


Management information

Registered date

2021 Year 11 Month 26 Day

Last modified on

2021 Year 11 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052723


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name