UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047009 |
|---|---|
| Receipt number | R000053519 |
| Scientific Title | The efficacy and safety of a telemedicine system in subjects with gestational diabetes mellitus; a randomized, open-label, parallel-group, controlled trial. |
| Date of disclosure of the study information | 2022/02/26 |
| Last modified on | 2024/03/03 16:06:31 |
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Basic information
Public title
A study of the efficacy of a telemedicine system in subjects with gestational diabetes mellitus.
Acronym
TELEGLAM
Scientific Title
The efficacy and safety of a telemedicine system in subjects with gestational diabetes mellitus; a randomized, open-label, parallel-group, controlled trial.
Scientific Title:Acronym
TELEGLAM
Region
| Japan |
Condition
Condition
gestational diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy and safety of a telemedicine system in subjects with gestational diabetes mellitus.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
We evaluate health care costs, PAID(Problem Area in Diabetes Survey), and DTR-QOL(Diabetes Therapy-Related QOL) before the intervention and 10 weeks after the intervention.
Key secondary outcomes
As glycemic control indicators, we evaluate fasting and postprandial blood glucose by self-monitoring records, frequency of hypoglycemia and hyperglycemia, insulin dose, HbA1c, and glycated albumin throughout the intervention period.
As perinatal outcomes, we evaluate the following: gestational age, fetal growth status, mode of delivery, maternal weight, obstetric complications that occur during the perinatal period such as premature rupture of the membrane and postpartum hemorrhage, maternal complications such as gestational hypertension, fetal indexes (sex, height, weight, neonatal hypoglycemia, Apgar score, large for gestational age. small for gestational age, shoulder dystocia), umbilical artery pH, incidence of congenital diseases, and admission to NICU (Neonatal Intensive Care Unit).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Face-to-face consultations will be conducted at the beginning and end of the intervention, and online consultations will be conducted in between. MeDaCa, an online consultation system, will be used. After the start of the intervention, online consultations will be conducted every two to three weeks, and the intervention will end at 10 weeks.
Interventions/Control_2
We perform face-to-face examination as usual.
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
1) Patients diagnosed as gestational diabetes by oral glucose tolerance test (OGTT) by 29 weeks and 6 days of gestation who have undergone self-monitoring of blood glucose and insulin injection.
2) Patients who have received sufficient explanation and understanding of the study and have given their written consent to participate in the study.
3) Patients who can understand and operate the MeDaCa system.
Key exclusion criteria
1) Patients diagnosed as gestational diabetes after 30 weeks and 0 days of gestation.
2) Patients diagnosed as overt diabetes in pregnancy.
3) Patients with type 2 diabetes.
4) Patients with type 1 diabetes.
5) Patients with serious uncontrolled complications.
6) Patients with pacemakers or other implantable medical devices.
7) Patients who have requested not to participate in the study.
8) Patients who are judged inappropriate to participate the study by the physicians.
9) Patients who do not have the Internet environment for online consultation.
10) Patients who do not use a smart phone.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shu |
| Middle name | |
| Last name | Meguro |
Organization
Keio University School of Medicine
Division name
Department of Endocrinology, Metabolism and Nephrology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3797
shumeg@z8.keio.jp
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Nakajima |
Organization
Keio University School of Medicine
Division name
Department of Endocrinology, Metabolism and Nephrology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3797
Homepage URL
yunakajima@keio.jp
Sponsor or person
Institute
Department of Endocrinology, Metabolism and Nephrology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 26 | 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
43
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
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | 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
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 25 | Day |
Last modified on
| 2024 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053519
