Clinical trial NCT05521893: Effectiveness of Telemedicine Care Replacing Standard Care in Gestational Diabetes
Official title: Effectiveness of Telemedicine Care Replacing Standard Care in Gestational Diabetes: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Keywords: telemedicine
glycemic control
perinatal outcomes
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* less then 30 weeks of gestation at enrolement
* GDM diagnosis
* at least moderate Slovenian language skills
* willingness to participate

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Average fasting glucose concentration
timeFrame: 1 month
measure: Percentage of glucose readings in the target range
timeFrame: 1 month
measure: Compliance with SMBG
timeFrame: 1 month
measure: The percentage of individuals needing insulin treatment
timeFrame: once during pregnancy
measure: Average postprandial glucose concentration
timeFrame: 1 month
Secondary outcomes:
measure: gestational weight gain
timeFrame: once during pregnancy
measure: Newborn birth weight
timeFrame: delivery
measure: LGA incidence
timeFrame: delivery
measure: Gestational age at birth
timeFrame: delivery
measure: Preterm birth
timeFrame: delivery
measure: Incidence of preeclampsia
timeFrame: delivery
measure: Incidence of caesarean section
timeFrame: delivery
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana
name: Drazenka Pongrac Barlovic
role: PRINCIPAL_INVESTIGATOR
References: