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

Gestational Diabetes Mellitus Clinical Trial

— SPARK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05348863
• Other study ID #: 2021-03093
• Status: Recruiting
• Phase: N/A
• Start date: October 28, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: January 2024
• Source: Karolinska Institutet
• Contact: Marie Löf, Professor
• Phone: +46 734 426417
• Email: marie.lof[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Sweden	Maternity health care, Region Östergötland	Linköping

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	Linkoeping University, Region Östergötland

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	HbA1c	Glycosylated hemoglobulin	At the end of the intervention in gestational weeks 36-37
Secondary	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
Secondary	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
Secondary	Incidence of pre-eclampsia	Diagnosis of pre-eclampsia	Up to delivery
Secondary	Incidence of Caesarean sections	Delivery by caesarean sections	Up to delivery
Secondary	Incidence of pregnancy induced hypertension	Diagnosis of pregnancy induced hypertension	Up to delivery
Secondary	Metformin/insulin treatment	Introduction of metformin/insulin treatment	Up to delivery
Secondary	Preterm birth	Delivery before 37 completed weeks	Up to delivery
Secondary	Gestational weight gain	Increase in body weight during pregnancy	From pre-prepregnancy up to 40 weeks of gestation
Secondary	Infant birth weight	Infant birth weight in grams	At birth
Secondary	Infant birth length	Infant birth length in centimetres	At birth
Secondary	Infant Apgar score	Infant Apgar score at 1, 5 and 10 min	At birth
Secondary	Incidence of large-for gestational-age infant	Birth weight >90th percentile for gestational age and gender	At birth
Secondary	Infant shoulder dystocia	Incidence of infant shoulder dystocia	At birth
Secondary	Infant hypoglycaemia	Incidence of infant hypoglycaemia	At birth
Secondary	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
Secondary	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
Secondary	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
Secondary	Delivery complications	Induction of delivery (yes or no), vacuum extraction (yes or no, epidural anesthesia (yes or no)	At delivery
Secondary	Hospital stay	Hospital stay (duration from admission of delivery to discharge) including neonatal care	The first week post partum
Secondary	Glucose- insulin treatment during delivery	Incidence of glucose- insulin treatment during delivery	During delivery
Secondary	Metabolic and inflammatory biomarkers I	Maternal levels of Insulin-like Growth Factor I in serum	At gestational weeks 36-37
Secondary	Metabolic and inflammatory biomarkers II	Maternal levels of Insulin-like Growth Factor I binding proteins in serum	At gestational weeks 36-37
Secondary	Metabolic and inflammatory biomarkers III	Maternal levels of copeptin in serum	At gestational week 36-37
Secondary	Metabolic and inflammatory biomarkers IV	Maternal levels of leptin in serum	At gestational week 36-37
Secondary	Metabolic and inflammatory biomarkers V	Maternal levels of midregion pro-adrenomedullin (MR-proANP) in serum	At gestational week 36-37
Secondary	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
Secondary	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
Secondary	Physical activity using accelerometry	Time spent on physical activity at different levels (sedentary, light, moderate, vigorous)	One year post partum