Clinical trial Recruiting at 1 site Interventional Ages 18 to 50 Women only

A digital platform to help manage gestational diabetes

Official title: SPARK: Smart Phone App for Gestational Diabetes Patients Supporting Key Lifestyle Behaviors and Glucose Control

Run by Karolinska Institutet · NCT05348863 · Data updated 2026-11-12

This study is testing whether a mobile health platform called SPARK can help women with gestational diabetes manage their condition better by providing support for healthy eating and exercise.

Quick facts

Study typeInterventional
Ages18 Years to 50 Years
SexWomen only
Enrollment360 (estimated)
SponsorKarolinska Institutet
Academic / other
Locations1 site (Linköping)
StatusRecruiting
StartedOctober 28, 2022
Main results expectedDecember 31, 2026
Study endsDecember 31, 2027
Registry record updatedAugust 10, 2026
Trial IDNCT05348863 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are women diagnosed with gestational diabetes mellitus as per the World Health Organization guidelines.

Probably not a fit

Patients with known pre-pregnancy diabetes, twin pregnancies, those under 18 years of age, or with severe co-morbidities may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project evaluates the effectiveness of a mobile health platform called SPARK in improving self-management for women diagnosed with gestational diabetes mellitus (GDM). The study is a multi-centre randomized controlled trial conducted in South Eastern Sweden, where participants will be divided into control and intervention groups. While all participants will receive standard care, the intervention group will also have access to the SPARK platform, which provides support for healthy eating, physical activity, and glycaemic control. The primary outcomes measured will include glycaemic control, diet, physical activity, and various biomarkers during late pregnancy.

Why it matters

Potential benefit: If successful, this platform could significantly enhance self-management of gestational diabetes, leading to better health outcomes for both mothers and their babies.

How similar studies have gone: Other studies have shown promise in using digital platforms for managing chronic conditions, suggesting that this approach could be effective for gestational diabetes as well.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* a confirmed diagnosis of GDM detected by oral glucose tolerance test in accordance with the World Health Organization guidelines

Exclusion Criteria:

* known pre-pregnancy diabetes
* twin pregnancy
* \<18 years of age
* severe co-morbidities that would limit participation or a previously diagnosed severe psychiatric illness.

Where it's running

  • Maternity health care, Region Östergötland
    Linköping, Sweden
    Recruiting

Study contacts

  • Principal investigator: Marie Löf, Professor — Karolinska Institutet
  • Study coordinator: Marie Löf, Professor
  • Email: marie.lof@ki.se
  • Phone: +46 734 426417

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.