Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05348863

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

Gestational diabetes mellitus (GDM) is an increasing public health challenge. Innovative, effective and scalable lifestyle interventions to support women with GDM to manage their disease and to prevent adverse obstetric and neonatal outcomes as well as later morbidity are requested.The aim of this project is to evaluate whether a novel, mobile health (mHealth) platform (SPARK) can improve self-management of GDM and prevent adverse maternal and offspring outcomes. SPARK is a multi-centre randomised controlled trial recruiting women diagnosed with GDM in South Eastern Sweden. Women will be randomised to the control or intervention group. All women will receive standard care. The intervention group will also receive support through the SPARK platform for healthy eating, physical activity and glycaemic control. Pregnancy outcomes are glycaemic control (primary), diet, physical activity, metabolic and inflammatory biomarkers in gestational week 36-37 as well as adverse obstetric and neonatal outcomes. Secondary outcomes also include cardiometabolic risk, physical activity and healthy eating behaviours one-year postpartum.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Gestational Diabetes Mellitus Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maternity health care, Region Östergötland

Linköping, 58185, Sweden

Location status: Recruiting

Location contact

Caroline Lilliecreutz, MD, Associate professor

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SPARK

Behavioral

The SPARK digital platform provides support to the patient (shown as an app) as well as provides the possibility for the health care provider to review and give feedback on blood glucose levels through the care giver interface of the platform.

Primary outcomes

  1. Glucose control

    Time frame: At the end of the intervention in gestational weeks 36-37

    Time in Range percent of time for glucose levels within clinical target levels using continous glucose monitoring

  2. HbA1c

    Time frame: At the end of the intervention in gestational weeks 36-37

    Glycosylated hemoglobulin

Secondary outcomes

  1. Diet intake quality using three dietary recalls by means of the Riksmaten Flex method

    Time frame: At the end of the intervention in gestational weeks 36-37

    Diet intake quality will be assessed using three 24 hour dietary recalls by means of the Riksmaten Flex web-based dietary recall method.

  2. Physical activity using accelerometry

    Time frame: At the end of the intervention in gestational weeks 36-37

    Time spent on physical activity at different levels (sedentary, light, moderate, vigorous) in minutes per day will be assessed using accelerometry collected during 7 days

  3. Incidence of pre-eclampsia

    Time frame: Up to delivery

    Diagnosis of pre-eclampsia

  4. Incidence of Caesarean sections

    Time frame: Up to delivery

    Delivery by caesarean sections

  5. Incidence of pregnancy induced hypertension

    Time frame: Up to delivery

    Diagnosis of pregnancy induced hypertension

  6. Metformin/insulin treatment

    Time frame: Up to delivery

    Introduction of metformin/insulin treatment

  7. Preterm birth

    Time frame: Up to delivery

    Delivery before 37 completed weeks

  8. Gestational weight gain

    Time frame: From pre-prepregnancy up to 40 weeks of gestation

    Increase in body weight during pregnancy

  9. Infant birth weight

    Time frame: At birth

    Infant birth weight in grams

  10. Infant birth length

    Time frame: At birth

    Infant birth length in centimetres

  11. Infant Apgar score

    Time frame: At birth

    Infant Apgar score at 1, 5 and 10 min

  12. Incidence of large-for gestational-age infant

    Time frame: At birth

    Birth weight >90th percentile for gestational age and gender

  13. Infant shoulder dystocia

    Time frame: At birth

    Incidence of infant shoulder dystocia

  14. Infant hypoglycaemia

    Time frame: At birth

    Incidence of infant hypoglycaemia

  15. Glucose control

    Time frame: From inclusion (baseline) to end of intervention in gestational week 36-37

    Adherence to protocol for daily glucose monitoring (four times per day)

  16. Glycaemic variability I

    Time frame: At the end of the intervention in gestational week 36-37

    Coefficient of variation for glucose excursion over 24 hrs using continous glucose monitoring

  17. Glycaemic variability II

    Time frame: At the end of the intervention in gestational week 36-37

    Mean for glucose excursion over 24 hrs using continous glucose monitoring

  18. Delivery complications

    Time frame: At delivery

    Induction of delivery (yes or no), vacuum extraction (yes or no, epidural anesthesia (yes or no)

  19. Hospital stay

    Time frame: The first week post partum

    Hospital stay (duration from admission of delivery to discharge) including neonatal care

  20. Glucose- insulin treatment during delivery

    Time frame: During delivery

    Incidence of glucose- insulin treatment during delivery

  21. Metabolic and inflammatory biomarkers I

    Time frame: At gestational weeks 36-37

    Maternal levels of Insulin-like Growth Factor I in serum

  22. Metabolic and inflammatory biomarkers II

    Time frame: At gestational weeks 36-37

    Maternal levels of Insulin-like Growth Factor I binding proteins in serum

  23. Metabolic and inflammatory biomarkers III

    Time frame: At gestational week 36-37

    Maternal levels of copeptin in serum

  24. Metabolic and inflammatory biomarkers IV

    Time frame: At gestational week 36-37

    Maternal levels of leptin in serum

  25. Metabolic and inflammatory biomarkers V

    Time frame: At gestational week 36-37

    Maternal levels of midregion pro-adrenomedullin (MR-proANP) in serum

  26. Maternal cardiometabolic risk profile

    Time frame: One year post partum

    A maternal cardiometabolic risk profile score one year post partum will be calculated using information on triglycerides and high-density cholesterol in serum, waist circumference, blood glucose as well as the systolic and diastolic blood pressure.

  27. Diet intake quality using three dietary recalls by means of the Riksmaten Flex method

    Time frame: One year post partum

    Diet intake quality will be assessed using three 24 hour dietary recalls by means of the Riksmaten Flex web-based dietary recall method.

  28. Physical activity using accelerometry

    Time frame: One year post partum

    Time spent on physical activity at different levels (sedentary, light, moderate, vigorous)

  29. Metabolic and inflammatory biomarkers VI

    Time frame: At gestational week 36-37

    Maternal levels of midregion pro-atrial natriuretic peptide (MR-proADM) in serum

  30. Glycaemic variability III

    Time frame: Full intervention period (up to 3 months)

    Glucose levels using glucose meter (capillary sampling)

  31. Microvascular function I

    Time frame: One year post partum

    Oxygen saturation using PeriFlux6000 Enhanced Perfusion and Oxygen Saturation

  32. Microvascular function II

    Time frame: One year post partum

    Total speed perfusion using PeriFlux6000 Enhanced Perfusion and Oxygen Saturation

Study contacts

Contact information is provided by the study sponsor or research team.

Marie Löf, Professor

CONTACT

[email protected]

+46 734 426417

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Linkoeping University
  • Region Östergötland

Registry information

Official study title

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

Acronym: SPARK

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 27, 2022
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.