UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044625 |
|---|---|
| Receipt number | R000050972 |
| Scientific Title | The Effectiveness of Hybrid Nutritional Guidance for Pregnant Women with Glucose Metabolic Disorders |
| Date of disclosure of the study information | 2021/07/05 |
| Last modified on | 2023/12/25 19:32:00 |
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Basic information
Public title
The Effectiveness of Hybrid Nutritional Guidance for Pregnant Women with Glucose Metabolic Disorders
Acronym
The Effectiveness of Hybrid Nutritional Guidance for Pregnant Women with Glucose Metabolic Disorders
Scientific Title
The Effectiveness of Hybrid Nutritional Guidance for Pregnant Women with Glucose Metabolic Disorders
Scientific Title:Acronym
The Effectiveness of Hybrid Nutritional Guidance for Pregnant Women with Glucose Metabolic Disorders
Region
| Japan |
Condition
Condition
Pregnant woman with glucose metabolic disorder
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Obstetrics and Gynecology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will examine whether hybrid nutritional guidance using a continuous glucose meter and dietary record management via a smartphone application and by dietitians, in pregnant women with glucose metabolic disorder.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in sensor glucose levels during the first, second, and third trimesters of pregnancy n pregnant women with glucose metabolic disorder.
Key secondary outcomes
(1) Changes in hemoglobin A1c and glycated albumin during the pregnant period.
(2) Changes in body weight during the pregnant period.
(3) Changes in dietary compliance during the pregnant period.
(4) Changes in Problem Area in Diabetes Survey (PAID), Diabetes Treatment Satisfaction Questionnaire (DTSQ), and Diabetes Diet-related Quality of Life Scale.
(5) Perinatal outcomes and adverse events, including skin disorders, associated with the use of Libre
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Pregnant women with abnormal glucose metabolism, GDM and pregnant women with diabetes, were treated at the Kitasato University Hospital during this study period.
Key exclusion criteria
(1) Blind patients
(2) Patients with other implantable medical devices (pacemakers, etc.)
(3) Patients using an insulin pump
(4) Patients who are not eligible judged by this study investigators
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Hayashi |
Organization
Kitasato University School of Medicine
Division name
Endocrinology, Diabetes and Metabolism
Zip code
2520374
Address
1-15-1 Kitasato Minami-ku Sagamihara Kanagawa
TEL
0427788111
ahayashi@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Hayashi |
Organization
Kitasato University School of Medicine
Division name
Endocrinology, Diabetes and Metabolism
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
0427788111
Homepage URL
ahayashi@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tanuma Green House Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Kitasato University School of Medicine
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel
0427788111
rinrib@med.kitasato-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
| 2021 | Year | 07 | Month | 05 | 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
31
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
Main results already published
Date of protocol fixation
| 2021 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 06 | Month | 23 | Day |
Last modified on
| 2023 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050972
