Gestational DiabetesNCT05521893
Effectiveness of Telemedicine Care Replacing Standard Care in Gestational Diabetes
A study testing Telemedicine care in people with Gestational Diabetes, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Telemedicine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSlovenia
- Study dates
- 12 Mar 2020to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- less then 30 weeks of gestation at enrolement
- GDM diagnosis
- at least moderate Slovenian language skills
- willingness to participate
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Telemedicine Care Replacing Standard Care in Gestational Diabetes: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Gestational Diabetes
- Being tested
- Telemedicine care, Standard care
- Keywords
- telemedicine, glycemic control, perinatal outcomes
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine careOther
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 careOther
In the standard care group, visits are scheduled at the diabetes clinic on a monthly basis.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine group | Experimental | Not described Receives: Other: Telemedicine care |
| Standard care group | Active comparator | Not described Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average fasting glucose concentration
Average fasting based on participant's SMBG in the 3rd trimester
Measured: 1 month
Percentage of glucose readings in the target range
average percentage for the 3rd trimester
Measured: 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
Measured: 1 month
The percentage of individuals needing insulin treatment
Measured: once during pregnancy
Average postprandial glucose concentration
Average postprandial glucose based on participant's SMBG in the 3rd trimester
Measured: 1 month
Secondary outcomes (7)
gestational weight gain
from pre-conception until labour
Measured: once during pregnancy
Newborn birth weight
Measured: delivery
LGA incidence
Measured: delivery
Gestational age at birth
Measured: delivery
Preterm birth
Measured: delivery
Incidence of preeclampsia
Measured: delivery
Incidence of caesarean section
Measured: delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start12 Mar 2020
- Primary completion20 Dec 2020
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Drazenka Pongrac Barlovic, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521893
- Sponsor's protocol ID
- 0120-302/2020-4
- Status last verified
- Jun 2022
- First submitted
- 27 Jun 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37185903
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Telemedicine Care Replacing Standard Care in Gestational Diabetes: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05521893
- Acronym / sponsor ID
- 0120-302/2020-4
- Conditions
- Gestational Diabetes
- Keywords
- telemedicine, glycemic control, perinatal outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine group | Experimental | Other: Telemedicine care |
| Standard care group | Active comparator | Other: Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- less then 30 weeks of gestation at enrolement
- GDM diagnosis
- at least moderate Slovenian language skills
- willingness to participate
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine careIn 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. | Other | Telemedicine group |
| Standard careIn the standard care group, visits are scheduled at the diabetes clinic on a monthly basis. | Other | Standard care group |
Primary outcome
Average fasting glucose concentration
Time frame: 1 month
Average fasting based on participant's SMBG in the 3rd trimester
Percentage of glucose readings in the target range
Time frame: 1 month
average percentage for the 3rd trimester
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
The percentage of individuals needing insulin treatment
Time frame: once during pregnancy
Average postprandial glucose concentration
Time frame: 1 month
Average postprandial glucose based on participant's SMBG in the 3rd trimester
7 secondary outcomes
gestational weight gain
Time frame: once during pregnancy
Newborn birth weight
Time frame: delivery
LGA incidence
Time frame: delivery
Gestational age at birth
Time frame: delivery
Preterm birth
Time frame: delivery
Incidence of preeclampsia
Time frame: delivery
Incidence of caesarean section
Time frame: delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Derived from this study: PubMed 37185903Munda 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Drazenka Pongrac Barlovic principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine care in people with Gestational Diabetes, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average fasting glucose concentration (time frame: 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05521893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2022.