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

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: Recruiting
• Conditions: Gestational Diabetes Mellitus
• Intervention / Treatment: Behavioral: SPARK

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	At the end of the intervention in gestational weeks 36-37
Incidence of pre-eclampsia	Diagnosis of pre-eclampsia	Up to delivery
Incidence of Caesarean sections	Delivery by caesarean sections	Up to delivery
Incidence of pregnancy induced hypertension	Diagnosis of pregnancy induced hypertension	Up to delivery
Metformin/insulin treatment	Introduction of metformin/insulin treatment	Up to delivery
Preterm birth	Delivery before 37 completed weeks	Up to delivery
Gestational weight gain	Increase in body weight during pregnancy	From pre-prepregnancy up to 40 weeks of gestation
Infant birth weight	Infant birth weight in grams	At birth
Infant birth length	Infant birth length in centimetres	At birth
Infant Apgar score	Infant Apgar score at 1, 5 and 10 min	At birth
Incidence of large-for gestational-age infant	Birth weight >90th percentile for gestational age and gender	At birth
Infant shoulder dystocia	Incidence of infant shoulder dystocia	At birth
Infant hypoglycaemia	Incidence of infant hypoglycaemia	At birth
Glycaemic variability I	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	Mean for glucose excursion over 24 hrs using continous glucose monitoring	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)	At delivery
Hospital stay	Hospital stay (duration from admission of delivery to discharge) including neonatal care	The first week post partum
Glucose- insulin treatment during delivery	Incidence of glucose- insulin treatment during delivery	During delivery
Metabolic and inflammatory biomarkers I	Maternal levels of Insulin-like Growth Factor I in serum	At gestational weeks 36-37
Metabolic and inflammatory biomarkers II	Maternal levels of Insulin-like Growth Factor I binding proteins in serum	At gestational weeks 36-37
Metabolic and inflammatory biomarkers III	Maternal levels of copeptin in serum	At gestational week 36-37
Metabolic and inflammatory biomarkers IV	Maternal levels of leptin in serum	At gestational week 36-37
Metabolic and inflammatory biomarkers V	Maternal levels of midregion pro-adrenomedullin (MR-proANP) in serum	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.	One year post partum
Glucose control	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	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 spent on physical activity at different levels (sedentary, light, moderate, vigorous)	One year post partum

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Linkoeping University; Region Östergötland
• Investigators: Principal Investigator: Marie Löf, Professor, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID 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