Gestational Diabetes Gestation Diabetes
Conditions
Interventions
Participants are randomized into two groups. A standard medical care group and an intervention group that uses the MLink application and recommends online medical care.
The standard care group
In the
telemedicine (Q46994)
telemedicine
Sponsors
IZUMIDA Yoshihiko
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Study subjects who meet all of the following selection and diagnostic criteria and none of the exclusion criteria will be enrolled as eligible. Selection Criteria 1. Fluent in Japanese 2. Single pregnancy 3. Age between 18 and 45 years at the time of consent 4. Pregnancy of less than 35 weeks and 0 days at the time of consent 5. Scheduled to give birth at Saitama Medical University General Hospital, Aiwa Hospital, Keiai Hospital, or Seto Hospital 6. Patients diagnosed with gestational diabetes mellitus based on IADPSG diagnostic criteria by a 75g oral glucose tolerance test between 24 weeks 0 days and 28 weeks 6 days of pregnancy Diagnostic criteria for gestational diabetes mellitus based on IADPSG criteria Diagnosis is made when one or more of the following criteria are met in a 75g OGTT. Fasting plasma glucose level >= 92mg/dL 1 hour value >=180mg/dL 2 hour value >=153mg/dL
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Any indication of hypertension before or by 19 weeks and 6 days including 19 weeks and 6 days of gestation of pregnancy 2.Serious history of cardiac, hepatic, or renal disease 3. Eating disorders. 4. Does not have a smartphone compatible with MLink to be used in this study or otherwise is unable to operate or view the data on her/his own 5. Research subjects who are deemed inappropriate for the safe conduct of this study by the Principal Investigator or Research Supervisor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage out of target blood glucose range at 2 h postprandial: Percentage of self-measured blood glucose levels that were out of target range during the protocol treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints *Percentage out of target blood glucose range before meal *Average blood glucose level *Adherence to blood glucose monitoring *HbA1c change during protocol treatment *Weight change from non-pregnant to pre-partum *Insulin therapy during the protocol treatment period *Gestational hypertension, gestational hypertension nephropathy *Weeks of birth *Preterm birth, late preterm birth *Mode of delivery *Questionnaire in postpartum and at the time of discontinuation of the study *Fetal birth weight *Small for Gestational Age (SGA), Large for Gestational Age (LGA) *Fetal macrosomia *Apgar score in 1min and 5 min *Composite outcome of neonatal complications | — |
Contacts
Public ContactTakashi OMURA
Saitama Medical University
Outcome results
None listed