Effectiveness of Telemedicine Care Replacing Standard Care in Gestational Diabetes
- Conditions
- Gestational Diabetes
- Interventions
- Other: Standard careOther: Telemedicine care
- Registration Number
- NCT05521893
- Lead Sponsor
- University Medical Centre Ljubljana
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 105
- less then 30 weeks of gestation at enrolement
- GDM diagnosis
- at least moderate Slovenian language skills
- willingness to participate
- more than 30 weeks of pregnancy
- overt diabetes or fasting glucose >6.9 mmol/l at diagnosis
- multiple pregnancy
- poor Slovene language skills
- history or bariatric surgery or other surgeries that induce malabsorbtion
- use of systemic steroids prior to enrolment
- presence of concomitant disease that could affect glucose control or self-management (e.g. uncontrolled psychiatric disorder)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard care group Standard care - Telemedicine group Telemedicine care -
- Primary Outcome Measures
Name Time Method Average postprandial glucose concentration 1 month Average postprandial glucose based on participant's SMBG in the 3rd trimester
Percentage of glucose readings in the target range 1 month average percentage for the 3rd trimester
Compliance with SMBG 1 month is defined as defined as the number of actual glucose measurements performed divided by the number of recommended glucose measurements\*100
Average fasting glucose concentration 1 month Average fasting based on participant's SMBG in the 3rd trimester
The percentage of individuals needing insulin treatment once during pregnancy
- Secondary Outcome Measures
Name Time Method Incidence of preeclampsia delivery gestational weight gain once during pregnancy from pre-conception until labour
LGA incidence delivery Preterm birth delivery Newborn birth weight delivery Gestational age at birth delivery Incidence of caesarean section delivery
Trial Locations
- Locations (1)
University Medical Centre Ljubljana
🇸🇮Ljubljana, Slovenia