UMIN-CTR Clinical Trial

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	Study of switching from BBT to BGT under CGM 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	Study of switching from BBT to BGT under CGM in T2DM
Region	Japan

Condition
Condition	Type 2 Diabetes Mellitus
Classification by specialty	Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It is important to consider changing to drugs that are unlikely to cause hypoglycemia in patients who have stable glycemic status. At the same time, however, it should be noted that inappropriate de-escalation of treatment leads to a worsening of the glycemic situation. Thus, 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	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Time Below Range and Time In Range for 3 days before and after treatment change.
Key secondary outcomes	Mean glucose levels, %CV for 3 days before and after treatment change and HbA1c, BMI immediately before and one month after the channge.

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	Adult type2 diabetic patients/Patients with HbA1c within management goals/Patients who receive only relatively small amount of bolus insulin/Patients wearing CGM when switching treatments
Key exclusion criteria	Patients with contraindicated duraglutide
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	060-8604
Address	Kita 11, Nishi 13, Chuo-ku, Sapporo, Japan
TEL	011-726-2211
Email	arina.miyoshi@doc.city.sapporo.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	060-8604
Address	Kita 11, Nishi 13, Chuo-ku, Sapporo, Japan
TEL	011-726-2211
Homepage URL
Email	arina.miyoshi@doc.city.sapporo.jp

Sponsor
Institute	Department of Diabetes and Endocrinology,Sapporo City General Hospital
Institute
Department

Funding Source
Organization	Department of Diabetes and Endocrinology,Sapporo City General Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Hokkaido University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Sapporo City General Hospital
Address	Kita 11, Nishi 13, Chuo-ku, Sapporo, Japan
Tel	011-726-2211
Email	arina.miyoshi@doc.city.sapporo.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 01 Month 04 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	2018 Year 10 Month 01 Day
Date of IRB	2019 Year 04 Month 19 Day
Anticipated trial start date	2019 Year 04 Month 20 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This is a retrospective obsevational study. We are analyzing 25 tareget patients and writing a treatise.

Management information
Registered date	2021 Year 01 Month 04 Day
Last modified on	2021 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048963