Effectiveness of Telemedicine Care Replacing Standard Care in Gestational Diabetes
NCT ID: NCT05521893
Last Updated: 2022-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
105 participants
INTERVENTIONAL
2020-03-12
2021-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Telemedicine group
Telemedicine care
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 group
Standard care
In the standard care group, visits are scheduled at the diabetes clinic on a monthly basis.
Interventions
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Telemedicine care
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
In the standard care group, visits are scheduled at the diabetes clinic on a monthly basis.
Eligibility Criteria
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Inclusion Criteria
* GDM diagnosis
* at least moderate Slovenian language skills
* willingness to participate
Exclusion Criteria
* 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)
18 Years
FEMALE
No
Sponsors
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University Medical Centre Ljubljana
OTHER
Responsible Party
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Principal Investigators
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Drazenka Pongrac Barlovic
Role: PRINCIPAL_INVESTIGATOR
University Medical Centre Ljubljana
Locations
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University Medical Centre Ljubljana
Ljubljana, , Slovenia
Countries
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References
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Munda A, Mlinaric Z, Jakin PA, Lunder M, Pongrac Barlovic D. Effectiveness of a comprehensive telemedicine intervention replacing standard care in gestational diabetes: a randomized controlled trial. Acta Diabetol. 2023 Aug;60(8):1037-1044. doi: 10.1007/s00592-023-02099-8. Epub 2023 Apr 25.
Other Identifiers
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0120-302/2020-4
Identifier Type: -
Identifier Source: org_study_id
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