Effectiveness of Telemedicine Care Replacing Standard Care in Gestational Diabetes

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05521893
• Other study ID #: 0120-302/2020-4
• Status: Completed
• Phase: N/A
• Start date: March 12, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: June 2022
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: October 31, 2021
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Slovenia	University Medical Centre Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average fasting glucose concentration	Average fasting based on participant's SMBG in the 3rd trimester	1 month
Primary	Percentage of glucose readings in the target range	average percentage for the 3rd trimester	1 month
Primary	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
Primary	The percentage of individuals needing insulin treatment		once during pregnancy
Primary	Average postprandial glucose concentration	Average postprandial glucose based on participant's SMBG in the 3rd trimester	1 month
Secondary	gestational weight gain	from pre-conception until labour	once during pregnancy
Secondary	Newborn birth weight		delivery
Secondary	LGA incidence		delivery
Secondary	Gestational age at birth		delivery
Secondary	Preterm birth		delivery
Secondary	Incidence of preeclampsia		delivery
Secondary	Incidence of caesarean section		delivery