Effectiveness of Telemedicine Care Replacing Standard Care in Gestational Diabetes

Study Overview
=================
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.

Official Title
-----------------
Effectiveness of Telemedicine Care Replacing Standard Care in Gestational Diabetes: a Randomized Controlled Trial

Conditions
-----------------
Gestational Diabetes

Intervention / Treatment
-----------------
* Other: Telemedicine care
* Other: Standard care


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine group<br> | Other: Telemedicine care<br>* 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.<br>|
| Active Comparator: Standard care group<br> | Other: Standard care<br>* In the standard care group, visits are scheduled at the diabetes clinic on a monthly basis.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average fasting glucose concentration | Average fasting based on participant's SMBG in the 3rd trimester | 1 month | 
| Percentage of glucose readings in the target range | average percentage for the 3rd trimester | 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 | 1 month | 
| The percentage of individuals needing insulin treatment |  | once during pregnancy | 
| Average postprandial glucose concentration | Average postprandial glucose based on participant's SMBG in the 3rd trimester | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gestational weight gain | from pre-conception until labour | once during pregnancy | 
| Newborn birth weight |  | delivery | 
| LGA incidence |  | delivery | 
| Gestational age at birth |  | delivery | 
| Preterm birth |  | delivery | 
| Incidence of preeclampsia |  | delivery | 
| Incidence of caesarean section |  | delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glycemic control, perinatal outcomes, telemedicine