A digital platform to help manage gestational diabetes
SPARK: Smart Phone App for Gestational Diabetes Patients Supporting Key Lifestyle Behaviors and Glucose Control
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Linköping) |
| Trial ID | NCT05348863 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women diagnosed with gestational diabetes mellitus as per the World Health Organization guidelines.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Linköping
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.