UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052747 |
|---|---|
| Receipt number | R000060188 |
| Scientific Title | The Effectiveness and Safety of Advanced Hybrid Closed-Loop Insulin Pump MiniMed 780G used in Japan: A Multicenter, Prospective, Observational Study |
| Date of disclosure of the study information | 2023/11/14 |
| Last modified on | 2024/11/11 17:32:54 |
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Basic information
Public title
The Effectiveness and Safety of Advanced Hybrid Closed-Loop Insulin Pump MiniMed 780G used in Japan: A Multicenter, Prospective, Observational Study
Acronym
ESA-J Study
Scientific Title
The Effectiveness and Safety of Advanced Hybrid Closed-Loop Insulin Pump MiniMed 780G used in Japan: A Multicenter, Prospective, Observational Study
Scientific Title:Acronym
ESA-J Study
Region
| Japan |
Condition
Condition
Type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is a single-arm prospective observational study to evaluate effectiveness and safety of MiniMed 780G, by comparing the data of type 1 diabetes patients in whom MiniMed 780G, an automated insulin pump, with the existing data of patients using conventional MiniMed 770G.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The percentage of the participants with time in range (TIR) being more than 70% at 52 weeks (Visit 2), compared to that at baseline (Visit 1)
Key secondary outcomes
HbA1c
Body mass index (BMI)
Auto Mode/ Smart Guard (per week)
Sensor Wear (per week)
Frequency of low glucose alert
Frequency of high glucose alert
Average blood glucose levels and standard deviation
Frequency of blood glucose measurements (per day)
Frequency of calibration (per day)
Total daily dose (per day)
Bolus amount (per day)
Auto correction amount (per day)
Auto Basal / Basal amount
Set Change
Reservoir Change
Meals (per day)
Carbs entered (per day)
Active insulin time
Mean sensor glucose level and standard deviation
Glucose management indicator (GMI)
% Coefficient of variation (%CV)
Change in TIR (at 13, 26, 39, 52 weeks from baseline)
Change in time below range (TBR) (Level 1, Level 2) (at 13, 26, 39, 52 weeks from baseline)
Change in time above range (TAR) (Level 1, Level 2) (at 13, 26, 39, 52 weeks from baseline)
Change in time in tight range (TITR)8 (at 13, 26, 39, 52 weeks from baseline)
Percentage of the participants with TIR more than 80% (at 13, 26, 39, 52 weeks)
Percentage of the participants with TIR more than 70% (at 13, 26, 39 weeks)
Percentage of the participants with TIR more than 60% (at 13, 26, 39, 52 weeks)
Percentage of the participants with TIR more than 50% (at 13, 26, 39, 52 weeks)
Glycemia risk index 9
Frequency of severe hypoglycemia
Frequency of diabetic ketoacidosis
Occurrence of serious adverse events (SAEs)
Occurrence of device-related serious adverse events (SAEs)
Occurrence of device-related unanticipated adverse events (adverse events: AEs)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[1] Type 1 diabetes patients (diagnosed based on the diagnostic criteria of the Japanese Diabetes Society)
[2] Aged 18 years or more at informed consent
[3] Patients starting to use MiniMed 780G
[4] Patients who had previously used MiniMed 770G for one year or more
Key exclusion criteria
[1] Pregnant patients
[2] Patients who had not used Auto Mode of MiniMed 770G
[3] Patients with difficulty in follow-up during the study period
Target sample size
172
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Murata |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Clinical Nutrition
Zip code
612-8555
Address
1-1 Fukakusamukaihatacho, Fushimi-ku, Kyoto, Japan
TEL
075-641-9161
drmurata@nifty.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Murata |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Clinical Nutrition
Zip code
612-8555
Address
1-1 Fukakusamukaihatacho, Fushimi-ku, Kyoto, Japan
TEL
075-641-9161
Homepage URL
drmurata@nifty.com
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
Medtronic
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
USA
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Medical Center Ethics Committee
Address
1-1 Fukakusamukaihatacho, Fushimi-ku, Kyoto, Japan
Tel
075-641-9161
yamamoto.yusuke.qg@mail.hosp.go.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
国立病院機構京都医療センター(京都府)、神戸大学大学院医学研究科(兵庫県)、東海大学医学部(神奈川県)、徳島大学糖尿病・臨床研究開発センター(徳島県)、東京女子医科大学(東京都)、慶應義塾大学医学部(東京都)、国立病院機構大阪医療センター(大阪府)、岡山済生会総合病院(岡山県)、国立病院機構兵庫中央病院(兵庫県)、綾部市立病院(京都府)、総合病院土浦協同病院(茨城県)、大阪公立大学大学院医学研究科(大阪府)、国立国際医療研究センター病院(東京都)、兵庫医科大学(兵庫県)、和歌山県立医科大学(和歌山県)
National Hospital Organization Kyoto Medical Center (Kyoto), Kobe University Graduate School of Medicine (Hyogo), Tokai University School of Medicine (Kanagawa), Tokushima University (Tokushima), Tokyo Women’s Medical University School of Medicine (Tokyo), Keio University School of Medicine (Tokyo), National Hospital Organization Osaka National Hospital (Osaka), Okayama Saiseikai General Hospital (Okayama), National Hospital Organization Hyogo-Chuo National Hospital (Hyogo), Ayabe City Hospital (Kyoto), Tsuchiura Kyodo General Hospital (Ibaraki), Osaka Metropolitan University Graduate School of Medicine (Osaka), National Center for Global Health and Medicine (Tokyo), Hyogo Medical University (Hyogo), Wakayama Medical University (Wakayama)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 14 | 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
163
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is single-arm prospective observational study. The participants will receive usual treatment continuously.
Management information
Registered date
| 2023 | Year | 11 | Month | 09 | Day |
Last modified on
| 2024 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060188
