Gestational Diabetes MellitusSPARKNCT05348863
SPARK- a Digital Platform to Improve Self-management of Gestational Diabetes
A study testing SPARK in people with Gestational Diabetes Mellitus, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- SPARK
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteSweden
- Study dates
- 28 Oct 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- a confirmed diagnosis of GDM detected by oral glucose tolerance test in accordance with the World Health Organization guidelines
Who cannot join
- known pre-pregnancy diabetes
- twin pregnancy
- <18 years of age
- severe co-morbidities that would limit participation or a previously diagnosed severe psychiatric illness.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Maternity health care, Region Östergötland
Linköping, 58185
Caroline Lilliecreutz, MD, Associate professor
About this study
Official title: 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.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- SPARK
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARKBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SPARK app | Experimental | 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. Receives: Behavioral: SPARK |
| Control arm | No intervention | Standard care i.e., the routine treatment program for GDM delivered by the care provider. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose control
Time in Range percent of time for glucose levels within clinical target levels using continous glucose monitoring
Measured: At the end of the intervention in gestational weeks 36-37
HbA1c
Glycosylated hemoglobulin
Measured: At the end of the intervention in gestational weeks 36-37
Secondary outcomes (32)
Diet intake quality using three dietary recalls by means of the Riksmaten Flex method
Diet intake quality will be assessed using three 24 hour dietary recalls by means of the Riksmaten Flex web-based dietary recall method.
Measured: At the end of the intervention in gestational weeks 36-37
Physical activity using accelerometry
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
Measured: At the end of the intervention in gestational weeks 36-37
Incidence of pre-eclampsia
Diagnosis of pre-eclampsia
Measured: Up to delivery
Incidence of Caesarean sections
Delivery by caesarean sections
Measured: Up to delivery
Incidence of pregnancy induced hypertension
Diagnosis of pregnancy induced hypertension
Measured: Up to delivery
Metformin/insulin treatment
Introduction of metformin/insulin treatment
Measured: Up to delivery
Preterm birth
Delivery before 37 completed weeks
Measured: Up to delivery
Gestational weight gain
Increase in body weight during pregnancy
Measured: From pre-prepregnancy up to 40 weeks of gestation
Infant birth weight
Infant birth weight in grams
Measured: At birth
Infant birth length
Infant birth length in centimetres
Measured: At birth
Infant Apgar score
Infant Apgar score at 1, 5 and 10 min
Measured: At birth
Incidence of large-for gestational-age infant
Birth weight >90th percentile for gestational age and gender
Measured: At birth
Infant shoulder dystocia
Incidence of infant shoulder dystocia
Measured: At birth
Infant hypoglycaemia
Incidence of infant hypoglycaemia
Measured: At birth
Glucose control
Adherence to protocol for daily glucose monitoring (four times per day)
Measured: From inclusion (baseline) to end of intervention in gestational week 36-37
Glycaemic variability I
Coefficient of variation for glucose excursion over 24 hrs using continous glucose monitoring
Measured: At the end of the intervention in gestational week 36-37
Glycaemic variability II
Mean for glucose excursion over 24 hrs using continous glucose monitoring
Measured: At the end of the intervention in gestational week 36-37
Delivery complications
Induction of delivery (yes or no), vacuum extraction (yes or no, epidural anesthesia (yes or no)
Measured: At delivery
Hospital stay
Hospital stay (duration from admission of delivery to discharge) including neonatal care
Measured: The first week post partum
Glucose- insulin treatment during delivery
Incidence of glucose- insulin treatment during delivery
Measured: During delivery
Metabolic and inflammatory biomarkers I
Maternal levels of Insulin-like Growth Factor I in serum
Measured: At gestational weeks 36-37
Metabolic and inflammatory biomarkers II
Maternal levels of Insulin-like Growth Factor I binding proteins in serum
Measured: At gestational weeks 36-37
Metabolic and inflammatory biomarkers III
Maternal levels of copeptin in serum
Measured: At gestational week 36-37
Metabolic and inflammatory biomarkers IV
Maternal levels of leptin in serum
Measured: At gestational week 36-37
Metabolic and inflammatory biomarkers V
Maternal levels of midregion pro-adrenomedullin (MR-proANP) in serum
Measured: At gestational week 36-37
Maternal cardiometabolic risk profile
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.
Measured: One year post partum
Diet intake quality using three dietary recalls by means of the Riksmaten Flex method
Diet intake quality will be assessed using three 24 hour dietary recalls by means of the Riksmaten Flex web-based dietary recall method.
Measured: One year post partum
Physical activity using accelerometry
Time spent on physical activity at different levels (sedentary, light, moderate, vigorous)
Measured: One year post partum
Metabolic and inflammatory biomarkers VI
Maternal levels of midregion pro-atrial natriuretic peptide (MR-proADM) in serum
Measured: At gestational week 36-37
Glycaemic variability III
Glucose levels using glucose meter (capillary sampling)
Measured: Full intervention period (up to 3 months)
Microvascular function I
Oxygen saturation using PeriFlux6000 Enhanced Perfusion and Oxygen Saturation
Measured: One year post partum
Microvascular function II
Total speed perfusion using PeriFlux6000 Enhanced Perfusion and Oxygen Saturation
Measured: One year post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start28 Oct 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Östergötland, Linkoeping University
- Responsible party
- Principal investigator, Marie Löf, docent, Karolinska Institutet
- Investigators
- Marie Löf, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348863
- Sponsor's protocol ID
- 2021-03093
- Acronym
- SPARK
- Status last verified
- Aug 2026
- First submitted
- 13 Apr 2022
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lilliecreutz C, Soderstrom E, Ersson M, Bendtsen M, Brown V, Kaegi-Braun N, Linder R, Maddison R, Chisalita SI, Lof M. SPARK: an mHealth intervention for self-management and treatment of gestational diabetes mellitus in Sweden - protocol for a randomised controlled trial. BMJ Open. 2025 Mar 3;15(3):e089355. doi: 10.1136/bmjopen-2024-089355.
PubMed 40032379
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPARK: Smart Phone App for Gestational Diabetes Patients Supporting Key Lifestyle Behaviors and Glucose Control
- ClinicalTrials.gov ID
- NCT05348863
- Acronym / sponsor ID
- SPARK / 2021-03093
- Conditions
- Gestational Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Östergötland, Linkoeping University
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPARK app | Experimental | Behavioral: SPARKAccess 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. |
| Control arm | No intervention | –Standard care i.e., the routine treatment program for GDM delivered by the care provider. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- a confirmed diagnosis of GDM detected by oral glucose tolerance test in accordance with the World Health Organization guidelines
Key exclusion criteria (4 listed)
- known pre-pregnancy diabetes
- twin pregnancy
- <18 years of age
- severe co-morbidities that would limit participation or a previously diagnosed severe psychiatric illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPARKThe 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. | Behavioural | SPARK app |
Primary outcome
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
HbA1c
Time frame: At the end of the intervention in gestational weeks 36-37
Glycosylated hemoglobulin
32 secondary outcomes
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
Physical activity using accelerometry
Time frame: At the end of the intervention in gestational weeks 36-37
Incidence of pre-eclampsia
Time frame: Up to delivery
Incidence of Caesarean sections
Time frame: Up to delivery
Incidence of pregnancy induced hypertension
Time frame: Up to delivery
Metformin/insulin treatment
Time frame: Up to delivery
Preterm birth
Time frame: Up to delivery
Gestational weight gain
Time frame: From pre-prepregnancy up to 40 weeks of gestation
Infant birth weight
Time frame: At birth
Infant birth length
Time frame: At birth
Infant Apgar score
Time frame: At birth
Incidence of large-for gestational-age infant
Time frame: At birth
Infant shoulder dystocia
Time frame: At birth
Infant hypoglycaemia
Time frame: At birth
Glucose control
Time frame: From inclusion (baseline) to end of intervention in gestational week 36-37
Glycaemic variability I
Time frame: 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
Delivery complications
Time frame: At delivery
Hospital stay
Time frame: The first week post partum
Glucose- insulin treatment during delivery
Time frame: During delivery
Metabolic and inflammatory biomarkers I
Time frame: At gestational weeks 36-37
Metabolic and inflammatory biomarkers II
Time frame: At gestational weeks 36-37
Metabolic and inflammatory biomarkers III
Time frame: At gestational week 36-37
Metabolic and inflammatory biomarkers IV
Time frame: At gestational week 36-37
Metabolic and inflammatory biomarkers V
Time frame: At gestational week 36-37
Maternal cardiometabolic risk profile
Time frame: One year post partum
Diet intake quality using three dietary recalls by means of the Riksmaten Flex method
Time frame: One year post partum
Physical activity using accelerometry
Time frame: One year post partum
Metabolic and inflammatory biomarkers VI
Time frame: At gestational week 36-37
Glycaemic variability III
Time frame: Full intervention period (up to 3 months)
Microvascular function I
Time frame: One year post partum
Microvascular function II
Time frame: One year post partum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Derived from this study: PubMed 40032379Lilliecreutz C, Soderstrom E, Ersson M, Bendtsen M, Brown V, Kaegi-Braun N, Linder R, Maddison R, Chisalita SI, Lof M. SPARK: an mHealth intervention for self-management and treatment of gestational diabetes mellitus in Sweden - protocol for a randomised controlled trial. BMJ Open. 2025 Mar 3;15(3):e089355. doi: 10.1136/bmjopen-2024-089355.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie Löf, Professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPARK in people with Gestational Diabetes Mellitus, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Löf, Professor (+46 734 426417, marie.lof@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose control (time frame: At the end of the intervention in gestational weeks 36-37). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05348863, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.