UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055096 |
|---|---|
| Receipt number | R000062466 |
| Scientific Title | Telecare nutritional Intervention study using a Real-time CGM for type 1 diabetes |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2026/01/30 15:29:03 |
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Basic information
Public title
Telecare nutritional Intervention study using a Real-time CGM for type 1 diabetes
Acronym
TIR-T1D Study
Scientific Title
Telecare nutritional Intervention study using a Real-time CGM for type 1 diabetes
Scientific Title:Acronym
TIR-T1D study
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 the efficacy and safety of a new insulin adjustment algorithm based on CGM metrics (Time in Range: TIR / Time Above Range: TAR / Time Below Range: TBR) obtained from Continuous Glucose Monitoring (CGM) .
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the percentage of TIR (defined as the proportion of time with glucose levels within the 70-180 mg/dL range) over the most recent 30 days obtained at week 0 and at week 24 in the intervention group and the control group.
Key secondary outcomes
･HbA1c,Glycoalbumin
･TAR, TIR, TBR
･sensor wear time, mean sensor glucose value, coefficient of variation, standard deviation, Glucose management indicator, Glycemia risk index, Hemoglobin Glycation Index
･Dose of Insulin
･Body weight, BMI
･QOL-related indicators (Problem Areas In Diabetes Survey, Diabetes Treatment Satisfaction Questionnaire, Hypoglycemia anxiety)
･Health economic indicators (Quality-adjusted life years, cost, Incremental Cost Effectiveness Ratio)
･Satisfaction with nutritional counseling
･Carbohydrate intake
･Proportion of cases achieving TIR > 70%
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
Provide remote nutritional counseling via video calls using an insulin adjustment algorithm based on CGM metrics (TIR/TAR/TBR).
Interventions/Control_2
Continue insulin adjustment during regular outpatient visits.
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Patients diagnosed with type 1 diabetes
(2)Patients using real-time continuous glucose monitoring (CGM)
(3)Patients with HbA1c levels of 7% or higher but 10% or lower
(4)Patients aged 18 to 64
(5)Patients who receive multiple daily insulin injections (four or more times a day, including at least one injection of long-acting or intermediate-acting insulin) or insulin pump therapy
(6)Patients who can provide written informed consent themselves
Key exclusion criteria
(1)Patients using insulin pump with closed-loop system and predictive low glucose management
(2)Patients who are pregnant or planning to become pregnant within one year and receiving preconception care
(3)Patients undergoing dialysis
(4)Patients with a history of severe hypoglycemia within the past six months
(5)Patients currently using oral steroids
(6)Patients unable to participate in video calls
(7)Patients deemed unsuitable by the trial investigator for any other reason
Target sample size
86
Research contact person
Name of lead principal investigator
| 1st name | Yushi |
| Middle name | |
| Last name | Hirota |
Organization
Kobe University
Division name
Diabetes and Endocrinology
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5861
hirota@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Yushi |
| Middle name | |
| Last name | Hirota |
Organization
Kobe University
Division name
Diabetes and Endocrinology
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5861
Homepage URL
hirota@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Yushi Hirota
Funding Source
Organization
Japan IDDM network
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
Kobe university hospital Clinical and translational research centor
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Tel
078-382-5400
ctrcpj-kenkyukanrijimu@med.kobe-u.ac.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
| 2024 | 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
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 29 | Day |
Last modified on
| 2026 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062466
