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

Study Overview
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Brief Summary
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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.

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

Conditions
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Gestational Diabetes Mellitus

Intervention / Treatment
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* Behavioral: SPARK


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPARK app<br>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<br>* 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.<br>|
| No Intervention: Control arm<br>Standard care i.e., the routine treatment program for GDM delivered by the care provider. | |

What is the study measuring?
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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 | 
| Glucose control | Time in Range percent of time for glucose levels above and below clinical target levels using continous glucose monitoring | At the end of the intervention in gestational week 36-37 | 
| 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 |