Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
Healthy Volunteers
ID05348863

SPARK: Smartphone App to Support Lifestyle and Blood Sugar Control in Gestational Diabetes Patients

Led by Karolinska Institutet · Updated on 2025-01-22

360

Participants Needed

1

Research Sites

217 weeks

Total Duration

On this page

Sponsors

K

Karolinska Institutet

Lead Sponsor

R

Region Östergötland

Collaborating Sponsor

AI-Summary

What this Trial Is About

Gestational diabetes mellitus (GDM) is a growing public health concern that requires effective and scalable lifestyle support for affected women to manage their condition and reduce risks for both mother and baby. This project aims to evaluate a new mobile health platform called SPARK, which is designed to help women with GDM improve self-management and prevent negative obstetric and neonatal outcomes. The study is a multi-center randomized controlled trial recruiting women with GDM in South Eastern Sweden. Participants will all receive standard care for GDM. In addition, those in the intervention group will use the SPARK digital platform, which supports healthy eating, physical activity, and glucose control. The platform includes an app for patients and a caregiver interface that allows healthcare providers to monitor blood glucose levels and provide feedback. The study will focus on outcomes measured at gestational weeks 36-37, including blood glucose control, HbA1c levels, diet, physical activity, and metabolic and inflammatory biomarkers. During the study, researchers will assess pregnancy outcomes as well as adverse obstetric and neonatal events. Secondary outcomes include cardiometabolic risk factors and behaviors related to physical activity and healthy eating one year after delivery. Participants will be monitored through the platform and clinical assessments to measure these outcomes and support ongoing management of GDM.

CONDITIONS

Official Title

SPARK- a Digital Platform to Improve Self-management of Gestational Diabetes

Who Can Participate

Age: 18Years - 50Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • A confirmed diagnosis of gestational diabetes mellitus detected by oral glucose tolerance test according to World Health Organization guidelines
  • Female participants aged 18 to 50 years
Not Eligible

You will not qualify if you...

  • Known diabetes diagnosed before pregnancy
  • Twin pregnancy
  • Younger than 18 years old
  • Severe co-morbidities limiting participation or previously diagnosed severe psychiatric illness

AI-Screening

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Trial Site Locations

Total: 1 location

1

Maternity health care, Region Östergötland

Linköping, Sweden, 58185

Actively Recruiting

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Research Team

M

Marie Löf, Professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

SPARK: an mHealth intervention for self-management and treatment of gestational diabetes mellitus in Sweden - protocol for a randomised controlled trial.

Caroline Lilliecreutz, Emmie Söderström, Matilda Ersson...

https://pubmed.ncbi.nlm.nih.gov/40032379