This is a a single-centre, parallel, randomized controlled trial in women with gestational diabetes mellitus (GDM). Women are randomized to routine monthly prenatal clinic care (standard care group) or a group sending daily glucose readings via an application installed on a smartphone and monthly individual videoconferences replacing in-person visits (telemedicine group). The overall aim is to compare the effectiveness of the combine synchronous and asynchronous telemedicine care with the standard care in women with GDM.
In our single-centre, parallel, randomized controlled trial in women with gestational diabetes (GDM) the investigators aim to compare the effectiveness of combined synchonous and asynchronous telemedicine care with the standard care. In the telemedicine group appointments are performed online via monthly scheduled videoconferences. Women also receive a smartphone with the installed application that enable transfer of the measured capillary glucose concetration at the same time it is performed. The glucose data sent by women are reviewed once per week and after that healthcare professionals contact women if necessary. On the other hand, in the standard care group, visits are scheduled normally on a monthly basis at the diabetes clinic. Intention-to-treat analysis is going to be performed. The investigators aim to compare glycemic control, gestational weight gain and perinatal data between groups. Student's t-test or Mann-Whitney U test will be used for normally or non-normally distributed variables. Differences between groups in categorical data will be calcuated by Chi square.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
In the telemedicine group, the appointments are performed online via scheduled videoconferences, on a monthly basis. All women in the telemedicine group receive a smartphone with the installed application that enable transfer of the measured capillary glucose concentration.
In the standard care group, visits are scheduled at the diabetes clinic on a monthly basis.
University Medical Centre Ljubljana
Ljubljana, Slovenia
Average fasting glucose concentration
Average fasting based on participant's SMBG in the 3rd trimester
Time frame: 1 month
Percentage of glucose readings in the target range
average percentage for the 3rd trimester
Time frame: 1 month
Compliance with SMBG
is defined as defined as the number of actual glucose measurements performed divided by the number of recommended glucose measurements\*100
Time frame: 1 month
The percentage of individuals needing insulin treatment
Time frame: once during pregnancy
Average postprandial glucose concentration
Average postprandial glucose based on participant's SMBG in the 3rd trimester
Time frame: 1 month
gestational weight gain
from pre-conception until labour
Time frame: once during pregnancy
Newborn birth weight
Time frame: delivery
LGA incidence
Time frame: delivery
Gestational age at birth
Time frame: delivery
Preterm birth
Time frame: delivery
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Incidence of preeclampsia
Time frame: delivery
Incidence of caesarean section
Time frame: delivery