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Completed

NCT Number: NCT05521893

Effectiveness of Telemedicine Care Replacing Standard Care in Gestational Diabetes

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Telemedicine care

Other

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.

Standard care

Other

In the standard care group, visits are scheduled at the diabetes clinic on a monthly basis.

Primary outcomes

  1. Average fasting glucose concentration

    Time frame: 1 month

    Average fasting based on participant's SMBG in the 3rd trimester

  2. Percentage of glucose readings in the target range

    Time frame: 1 month

    average percentage for the 3rd trimester

  3. Compliance with SMBG

    Time frame: 1 month

    is defined as defined as the number of actual glucose measurements performed divided by the number of recommended glucose measurements*100

  4. The percentage of individuals needing insulin treatment

    Time frame: once during pregnancy

  5. Average postprandial glucose concentration

    Time frame: 1 month

    Average postprandial glucose based on participant's SMBG in the 3rd trimester

Secondary outcomes

  1. gestational weight gain

    Time frame: once during pregnancy

    from pre-conception until labour

  2. Newborn birth weight

    Time frame: delivery

  3. LGA incidence

    Time frame: delivery

  4. Gestational age at birth

    Time frame: delivery

  5. Preterm birth

    Time frame: delivery

  6. Incidence of preeclampsia

    Time frame: delivery

  7. Incidence of caesarean section

    Time frame: delivery

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Aug 30, 2022
Registry last updated
Aug 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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