UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055060 |
|---|---|
| Receipt number | R000062897 |
| Scientific Title | Glycemic excursion in patients with type 1 diabetes by late evening snacks with different amounts of fat and carbohydrate in an educational camp: effect on nocturnal hyperglycemia and hypoglycemia |
| Date of disclosure of the study information | 2024/07/28 |
| Last modified on | 2025/02/05 16:22:57 |
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Basic information
Public title
Change in blood-sugar levels of patients with type 1 diabetes after late evening snacks with different amounts of fat and carbohydrate in an educational camp: effect on high and low levels of blood sugar during night-time
Acronym
Type1DM-CampLES study
Scientific Title
Glycemic excursion in patients with type 1 diabetes by late evening snacks with different amounts of fat and carbohydrate in an educational camp: effect on nocturnal hyperglycemia and hypoglycemia
Scientific Title:Acronym
T1DM-CampLES study
Region
| Japan |
Condition
Condition
Type 1 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To obtain evidences for administration of insulin dose for meals affected with protein and fat, and to explore foods suitable for management of nocturnal glycemic control in educational camp and daily life
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
pre-prandial blood glucose range of 70-180mg/dl by SMBG in the next morning (supplementary food intake for hypoglycemia or bolus insulin infusion for hyperglycemia are to be determined as exclusion from this range)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Wiener sausage 150g
once as a late evening snack
Interventions/Control_2
skipjack tuna 100g
once as a late evening snack
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
people with type 1 diabetes mellitus as participants of the educational camp
Key exclusion criteria
clinical inedible conditions
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Shoko |
| Middle name | |
| Last name | Komatsu |
Organization
Otemae University
Division name
Faculty of Health and Nutrition
Zip code
5400008
Address
2-1-88 Otemae, Chuo-ku, Osaka-shi, Osaka 540-0008 Japan
TEL
06-6941-7087
shoko@otemae.ac.jp
Public contact
Name of contact person
| 1st name | Shoko |
| Middle name | |
| Last name | Komatsu |
Organization
Otemae University
Division name
Faculty of Health and Nutrition
Zip code
5400008
Address
2-1-88 Otemae, Chuo-ku, Osaka-shi, Osaka 540-0008 Japan
TEL
06-6941-7087
Homepage URL
shoko@otemae.ac.jp
Sponsor or person
Institute
Otemae University
Institute
Department
Personal name
Shoko Komatsu
Funding Source
Organization
Otemae University
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
Otemae University, Faculty of Health and Nutrition
Address
2-1-88 Otemae, Chuo-ku, Osaka-shi, Osaka 540-0008 Japan
Tel
06-6941-7087
shoko@otemae.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 | 07 | Month | 28 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 29 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 10 | Month | 15 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 24 | Day |
Last modified on
| 2025 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062897
