NCT05521893

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
Last Updated

August 30, 2022

Status Verified

June 1, 2022

Enrollment Period

9 months

First QC Date

June 27, 2022

Last Update Submit

August 25, 2022

Conditions

Gestational Diabetes

Keywords

telemedicineglycemic controlperinatal outcomes

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (7)

  • gestational weight gain

    once during pregnancy

  • Newborn birth weight

    delivery

  • LGA incidence

    delivery

  • Gestational age at birth

    delivery

  • Preterm birth

    delivery

  • +2 more secondary outcomes

Study Arms (2)

Telemedicine group

EXPERIMENTAL
Other: Telemedicine care

Standard care group

ACTIVE COMPARATOR
Other: Standard care

Interventions

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.

Telemedicine group
Standard careOTHER

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

Standard care group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • less then 30 weeks of gestation at enrolement
  • GDM diagnosis
  • at least moderate Slovenian language skills
  • willingness to participate

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

  • 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.

    PMID: 37185903DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

TelemedicineStandard of Care

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services AdministrationQuality Indicators, Health CareQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Drazenka Pongrac Barlovic

    University Medical Centre Ljubljana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2022

First Posted

August 30, 2022

Study Start

March 12, 2020

Primary Completion

December 20, 2020

Study Completion

October 31, 2021

Last Updated

August 30, 2022

Record last verified: 2022-06

Locations

SL(1)