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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000046200
Receipt No. 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

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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
Institute Sapporo City General Hospital
Institute
Department

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
URL(English) 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


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