Effectiveness of Telemedicine Care Replacing Standard Care in Gestational Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes
• Intervention / Treatment: Other: Telemedicine care; Other: Standard care

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 Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Medical Centre Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Investigators: Principal Investigator: Drazenka Pongrac Barlovic, University Medical Centre Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2020
• Primary Completion (Actual): December 20, 2020
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Actual): August 30, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: telemedicine; glycemic control; perinatal outcomes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: 0120-302/2020-4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No