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

August 6, 2026 updated by: Marie Löf, docent, Karolinska Institutet

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Marie Löf, Professor
  • Phone Number: +46 734 426417
  • Email: marie.lof@ki.se

Study Locations

  • Sweden
      • Linköping, Sweden, 58185
        • Recruiting
        • Maternity health care, Region Östergötland
        • Contact:
          • Caroline Lilliecreutz, MD, Associate professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SPARK app
Access to the SPARK app which will provide support for a healthier diet and increased physical activity as well as daily monitoring of blood glucose levels.
Behavioral: SPARK
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.
No Intervention: Control arm
Standard care i.e., the routine treatment program for GDM delivered by the care provider.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
At the end of the intervention in gestational weeks 36-37
HbA1c
Time Frame: At the end of the intervention in gestational weeks 36-37
Glycosylated hemoglobulin
At the end of the intervention in gestational weeks 36-37

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At the end of the intervention in gestational weeks 36-37
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
At the end of the intervention in gestational weeks 36-37
Incidence of pre-eclampsia
Time Frame: Up to delivery
Diagnosis of pre-eclampsia
Up to delivery
Incidence of Caesarean sections
Time Frame: Up to delivery
Delivery by caesarean sections
Up to delivery
Incidence of pregnancy induced hypertension
Time Frame: Up to delivery
Diagnosis of pregnancy induced hypertension
Up to delivery
Metformin/insulin treatment
Time Frame: Up to delivery
Introduction of metformin/insulin treatment
Up to delivery
Preterm birth
Time Frame: Up to delivery
Delivery before 37 completed weeks
Up to delivery
Gestational weight gain
Time Frame: From pre-prepregnancy up to 40 weeks of gestation
Increase in body weight during pregnancy
From pre-prepregnancy up to 40 weeks of gestation
Infant birth weight
Time Frame: At birth
Infant birth weight in grams
At birth
Infant birth length
Time Frame: At birth
Infant birth length in centimetres
At birth
Infant Apgar score
Time Frame: At birth
Infant Apgar score at 1, 5 and 10 min
At birth
Incidence of large-for gestational-age infant
Time Frame: At birth
Birth weight >90th percentile for gestational age and gender
At birth
Infant shoulder dystocia
Time Frame: At birth
Incidence of infant shoulder dystocia
At birth
Infant hypoglycaemia
Time Frame: At birth
Incidence of infant hypoglycaemia
At birth
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
At the end of the intervention in gestational week 36-37
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
At the end of the intervention in gestational week 36-37
Delivery complications
Time Frame: At delivery
Induction of delivery (yes or no), vacuum extraction (yes or no, epidural anesthesia (yes or no)
At delivery
Hospital stay
Time Frame: The first week post partum
Hospital stay (duration from admission of delivery to discharge) including neonatal care
The first week post partum
Glucose- insulin treatment during delivery
Time Frame: During delivery
Incidence of glucose- insulin treatment during delivery
During delivery
Metabolic and inflammatory biomarkers I
Time Frame: At gestational weeks 36-37
Maternal levels of Insulin-like Growth Factor I in serum
At gestational weeks 36-37
Metabolic and inflammatory biomarkers II
Time Frame: At gestational weeks 36-37
Maternal levels of Insulin-like Growth Factor I binding proteins in serum
At gestational weeks 36-37
Metabolic and inflammatory biomarkers III
Time Frame: At gestational week 36-37
Maternal levels of copeptin in serum
At gestational week 36-37
Metabolic and inflammatory biomarkers IV
Time Frame: At gestational week 36-37
Maternal levels of leptin in serum
At gestational week 36-37
Metabolic and inflammatory biomarkers V
Time Frame: At gestational week 36-37
Maternal levels of midregion pro-adrenomedullin (MR-proANP) in serum
At gestational week 36-37
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.
One year post partum
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)
From inclusion (baseline) to end of intervention in gestational week 36-37
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.
One year post partum
Physical activity using accelerometry
Time Frame: One year post partum
Time spent on physical activity at different levels (sedentary, light, moderate, vigorous)
One year post partum
Metabolic and inflammatory biomarkers VI
Time Frame: At gestational week 36-37
Maternal levels of midregion pro-atrial natriuretic peptide (MR-proADM) in serum
At gestational week 36-37
Glycaemic variability III
Time Frame: Full intervention period (up to 3 months)
Glucose levels using glucose meter (capillary sampling)
Full intervention period (up to 3 months)
Microvascular function I
Time Frame: One year post partum
Oxygen saturation using PeriFlux6000 Enhanced Perfusion and Oxygen Saturation
One year post partum
Microvascular function II
Time Frame: One year post partum
Total speed perfusion using PeriFlux6000 Enhanced Perfusion and Oxygen Saturation
One year post partum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Linkoeping University
Region Östergötland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marie Löf, Professor, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-03093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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