gestational diabetes mellitus
Conditions
Interventions
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. A
Sponsors
Department of Endocrinology, Metabolism and Nephrology, Keio University School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Japan
Contacts
Public ContactYuya Nakajima
Keio University School of Medicine Department of Endocrinology, Metabolism and Nephrology
Outcome results
None listed