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

NCT05348863 | Recruiting

• 1 other identifier: 2021-03093
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (2)

• Glucose control

  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

  Glycosylated hemoglobulin

  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

  At the end of the intervention in gestational weeks 36-37

• Physical activity using accelerometry

  At the end of the intervention in gestational weeks 36-37

• Incidence of pre-eclampsia

  Up to delivery

• Incidence of Caesarean sections

  Up to delivery

• Incidence of pregnancy induced hypertension

  Up to delivery

Study Arms (2)

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.

Behavioral: SPARK

Control arm

NO INTERVENTION

Standard care i.e., the routine treatment program for GDM delivered by the care provider.

Interventions

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.

SPARK app

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Östergötland: collaborator
• Linkoeping University: collaborator

Study Sites (1)

Maternity health care, Region Östergötland

Linköping, 58185, Sweden

RECRUITING

Related Publications (1)

• 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.

  PMID: 40032379 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

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

Study Officials

• Marie Löf, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Löf, Professor

CONTACT

+46 734 426417; marie.lof@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 27, 2022
• Study Start: October 28, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)