UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061964 |
|---|---|
| Receipt number | R000070906 |
| Scientific Title | Observational Study on Performance Evaluation of Insulin Dose Decision Support System for People with Type 1 Diabetes |
| Date of disclosure of the study information | 2026/06/22 |
| Last modified on | 2026/06/18 15:34:28 |
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Basic information
Public title
Observational Study on Performance Evaluation of Insulin Dose Decision Support System for People with Type 1 Diabetes
Acronym
Performance Evaluation of Insulin Dose Decision Support System
Scientific Title
Observational Study on Performance Evaluation of Insulin Dose Decision Support System for People with Type 1 Diabetes
Scientific Title:Acronym
Performance Evaluation of Insulin Dose Decision Support System for People with Type 1 Diabetes
Region
| Japan |
Condition
Condition
Type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether the reference values for insulin doses calculated by the investigational device are within a clinically acceptable range compared to the insulin doses prescribed by diabetologists, using clinical data from patients with type 1 diabetes on multiple daily injection therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To determine the accuracy rate per prescription, where a "correct" case is defined as the difference between the reference insulin dose calculated by the investigational device and the insulin dose prescribed by a diabetologist being within an acceptable range for bolus insulin (morning, noon, evening) and basal insulin.
Key secondary outcomes
1. Comparison of total insulin doses
2. Accuracy rate per patient
3. Evaluation of glucose profiles
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) Patients with type 1 diabetes on multiple daily injection therapy using only rapid-acting insulin analogs and long-acting insulin analogs (insulin glargine, insulin degludec, insulin detemir).
(2) Patients who have been using a CGM for 24 weeks or longer at the time of Visit 3.
(3) Patients who are 18 years of age or older at the time of Visit 3.
(4) Patients who are able to provide written informed consent based on their own free will after understanding the contents of the explanatory document.
Key exclusion criteria
(1) Patients diagnosed with type 2 diabetes, latent autoimmune diabetes in adults (LADA), gestational diabetes, or other specific types of diabetes other than type 1, or patients prescribed insulin for purposes other than glycemic control.
(2) Patients using oral hypoglycemic agents other than SGLT2 inhibitors or alpha-glucosidase inhibitors.
(3) Patients who have had SGLT2 inhibitors or alpha-glucosidase inhibitors newly added, dose-adjusted, or discontinued, or who have changed their CGM device during the CGM measurement period used for evaluation.
(4) Patients who have experienced severe hypoglycemia within 6 months prior to Visit 1, or have an HbA1c of 9% or higher at Visit 3.
(5) Patients who determine their insulin dosage based on a carbohydrate-to-insulin ratio.
(6) Patients who are prescribed a once-weekly long-acting insulin analog injection.
(7) Patients using two or more types of bolus insulin products.
(8) Patients receiving basal insulin twice daily.
(9) Patients whose insulin doses are adjusted in 0.5-unit increments.
(10) Patients for whom the collected CGM data measurement time is less than 70% of the 28-day evaluation period or who have other specified missing input data.
(11) Patients who did not have their body weight measured between Visit 1 and Visit 3.
(12) Patients with or suspected of having diabetic gastroparesis.
(13) Patients with advanced diabetic autonomic neuropathy.
(14) Patients with or suspected of having pre-proliferative or proliferative diabetic retinopathy.
(15) Patients with concomitant diseases or receiving treatments that affect glycemic control.
(16) Any other patients whom the investigator deems unsuitable for participation in the study or whose condition may affect the performance evaluation.
Target sample size
115
Research contact person
Name of lead principal investigator
| 1st name | Rimei |
| Middle name | |
| Last name | Nishimura |
Organization
The Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology Department of Internal Medicine
Zip code
105-8471
Address
3-25-8 Nishishimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
rimei@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Niibe |
Organization
TERUMO CORPORATION
Division name
R&D Department, Life Care Solutions Division, Medical Care Solutions Company
Zip code
259-0151
Address
1500 Inokuchi, Nakai-machi, Ashigarakami-gun, Kanagawa
TEL
0465-81-4256
Homepage URL
kenta.niibe@terumo.co.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
TERUMO CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Jikei University School of Medicine
Address
3-25-8 Nishishimbashi, Minato-ku, Tokyo
Tel
03-3433-1111
jikei@esct.bvits.com
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
| 2026 | Year | 06 | Month | 22 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate the relationships: Differences between facilities, Differences in insulin preparations, etc.
Management information
Registered date
| 2026 | Year | 06 | Month | 18 | Day |
Last modified on
| 2026 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070906
