Gestational Diabetes Mellitus
Conditions
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.
Interventions
BEHAVIORALSPARK
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.
Sponsors
Region Östergötland
Linkoeping University
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose control | 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 | At the end of the intervention in gestational weeks 36-37 | Glycosylated hemoglobulin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of pre-eclampsia | Up to delivery | Diagnosis of pre-eclampsia |
| Incidence of Caesarean sections | Up to delivery | Delivery by caesarean sections |
| Incidence of pregnancy induced hypertension | Up to delivery | Diagnosis of pregnancy induced hypertension |
| Metformin/insulin treatment | Up to delivery | Introduction of metformin/insulin treatment |
| Preterm birth | Up to delivery | Delivery before 37 completed weeks |
| Gestational weight gain | From pre-prepregnancy up to 40 weeks of gestation | Increase in body weight during pregnancy |
| Infant birth weight | At birth | Infant birth weight in grams |
| Infant birth length | At birth | Infant birth length in centimetres |
| Infant Apgar score | At birth | Infant Apgar score at 1, 5 and 10 min |
| Incidence of large-for gestational-age infant | At birth | Birth weight \>90th percentile for gestational age and gender |
| Infant shoulder dystocia | At birth | Incidence of infant shoulder dystocia |
| Infant hypoglycaemia | At birth | Incidence of infant hypoglycaemia |
| Glucose control | From inclusion (baseline) to end of intervention in gestational week 36-37 | Adherence to protocol for daily glucose monitoring (four times per day) |
| Glycaemic variability I | At the end of the intervention in gestational week 36-37 | Coefficient of variation for glucose excursion over 24 hrs using continous glucose monitoring |
| 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 | Diet intake quality will be assessed using three 24 hour dietary recalls by means of the Riksmaten Flex web-based dietary recall method. |
| Delivery complications | At delivery | Induction of delivery (yes or no), vacuum extraction (yes or no, epidural anesthesia (yes or no) |
| Hospital stay | The first week post partum | Hospital stay (duration from admission of delivery to discharge) including neonatal care |
| Glucose- insulin treatment during delivery | During delivery | Incidence of glucose- insulin treatment during delivery |
| Metabolic and inflammatory biomarkers I | At gestational weeks 36-37 | Maternal levels of Insulin-like Growth Factor I in serum |
| Metabolic and inflammatory biomarkers II | At gestational weeks 36-37 | Maternal levels of Insulin-like Growth Factor I binding proteins in serum |
| Metabolic and inflammatory biomarkers III | At gestational week 36-37 | Maternal levels of copeptin in serum |
| Metabolic and inflammatory biomarkers IV | At gestational week 36-37 | Maternal levels of leptin in serum |
| Metabolic and inflammatory biomarkers V | At gestational week 36-37 | Maternal levels of midregion pro-adrenomedullin (MR-proANP) in serum |
| Maternal cardiometabolic risk profile | One year post partum | 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. |
| Metabolic and inflammatory biomarkers VI | At gestational week 36-37 | Maternal levels of midregion pro-atrial natriuretic peptide (MR-proADM) in serum |
| Glycaemic variability III | Full intervention period (up to 3 months) | Glucose levels using glucose meter (capillary sampling) |
| Microvascular function I | One year post partum | Oxygen saturation using PeriFlux6000 Enhanced Perfusion and Oxygen Saturation |
| Microvascular function II | One year post partum | Total speed perfusion using PeriFlux6000 Enhanced Perfusion and Oxygen Saturation |
| Glycaemic variability II | At the end of the intervention in gestational week 36-37 | Mean for glucose excursion over 24 hrs using continous glucose monitoring |
| Physical activity using accelerometry | At the end of the intervention in gestational weeks 36-37 | 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 |
Countries
Sweden
Contacts
Primary ContactMarie Löf, Professor
Outcome results
None listed