Gestational Diabetes Clinical Trial
— eMOMGDMOfficial title:
eHealth in Treatment of Gestational Diabetes - eMOM GDM -Study (Phase 2)
Verified date | November 2023 |
Source | Helsinki University Central Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The overall aim of the eMOM GDM-project is to develop and evaluate a novel system to clinical decision making and patient behavior change in treatment of GDM, combining diet, physical activity, sleep, heart rate (e.g. stress), and glucose monitoring within a single system (the eMOM GDM application), and linking the developed application tool for the normal health care system in a new way. In this second phase of the project, the effect of eMOM GDM application on maternal and neonatal outcomes will be evaluated in a randomized controlled study design. The follow-up study continues until 3 months postpartum.
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | December 2024 |
Est. primary completion date | December 12, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - GDM diagnoses at 24-28 gestational weeks Exclusion Criteria: - type 1 or type 2 diabetes - use of medication that influences glucose metabolism (such as continuous therapy with oral corticosteroids or metformin) - multiple pregnancy - physical disability - current substance abuse - severe psychiatric disorder (that complicates participation to the study) - significant difficulty in cooperating (e.g. inadequate Finnish language skills) |
Country | Name | City | State |
---|---|---|---|
Finland | Helsinki University Hospital | Helsinki |
Lead Sponsor | Collaborator |
---|---|
Helsinki University Central Hospital | Aalto University, Business Finland, Elisa Oyj, Finnish Institute for Health and Welfare, Fujitsu, Tampere University, UKK Institute, University of Helsinki |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in fasting glucose | change in fasting glucose measured by Huslab (laboratory measurement) | from gestational weeks 24-28 to gestational weeks 35-37 | |
Secondary | Fingertips fasting glucose values | Measured with Contour Next One | from gestational weeks 24-28 up to delivery | |
Secondary | Fingertips postbrandial glucose values | Measured with Contour Next One | from gestational weeks 24-28 up to delivery | |
Secondary | Fingertips area under the glucose curve | Measured with Contour Next One | from gestational weeks 24-28 up to delivery | |
Secondary | Gestational weight | Measured with Seca Mod 8787041649 (scale) and registered from antenatal card | weight measured at gestational weeks 24-28 and at 35-37 and collected from antenatal card during whole pregnancy and up to delivery | |
Secondary | Postpartum weight | Measured with Seca Mod 8787041649 (scale) | weight measured at 3 months postpartum | |
Secondary | Physical activity level | Measured with the accelerometers UKK RM42 and Firstbeat Bodyguard 2 | at gestational weeks 24-28, 35-37 and at 3 months postpartum | |
Secondary | Total diet | Measured with a questionnaire (food frequencey questionnaire, FFQ) concerning participant's diet during previous month. FFQ contains questions about the frequency (number of times per day, week, or month) and the amount of foods consumed in units of common serving sizes. Nutritional quality of total diet is assessed based on calculated daily consumption of foods and intake of nutrients. Better nutritional quality is related to e.g. higher intake of fruits and vegetables, wholegrain cereals, fiber and unsaturated fat, and lower intake of added sugar and saturated fat. | at gestational weeks 24-28), 35-37 and at 3 months postpartum | |
Secondary | Neonatal body fat% | Measured with PEA POD Cosmed | one measure within 0-3 days after birth of the child | |
Secondary | Motivation to manage GDM | Measured with a motivation questionnaire (TSRQ and PCS). Minimum value is 1 and maximum 5. The higher score means higher autonomous motivation to manage GDM. | at gestational weeks 24-28 and 35-37 | |
Secondary | Percentage of participants on metformin treatment | Percentage of participants need for metformin treatment | up to 42 gestational weeks | |
Secondary | Percentage of participants on insulin treatment | Percentage of participants need for insulin treatment | up to 42 gestational weeks | |
Secondary | Newborn birthweight and macrosomia | Newborn birth weight and macrosomia (birthweight >4kg) | one measure at birth | |
Secondary | Incidence of neonatal hypoglycemia | Percentage of neonatal hypoglycemia requiring intravenous glucose | within a week from birth | |
Secondary | Incidence of newborn large for gestational age | Percentage of newborn with birthweight percentile > + 2 SD | one measure at birth | |
Secondary | Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | Change in HOMA-IR measured by Huslab (laboratory measurement), calculated as: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. | gestational weeks 24-28, gestational weeks 35-37, 3 months postpartum | |
Secondary | 2-h OGTT | 2-hour blood glucose levels measured with OGTT (75g) | 3 months postpartum | |
Secondary | Stress levels | Calculated based on dedicated HRV-based algorithm by Firstbeat. Defined as percentages. | gestational weeks 24-28, gestational weeks 35-37, 3 months postpartum | |
Secondary | Costs | Costs of the intervention and treatment in healthcare. Defined as €/participant. | gestational weeks 24-28, 3 months postpartum |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05081037 -
Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS)
|
N/A | |
Active, not recruiting |
NCT03249896 -
Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes
|
N/A | |
Terminated |
NCT03749889 -
Low Carb vs Normal Carb in Pregnancy
|
N/A | |
Completed |
NCT03859193 -
Education Nutritional Video for Gestational Diabetics
|
N/A | |
Recruiting |
NCT05037526 -
Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care in Pregnancy Outcomes
|
N/A | |
Completed |
NCT06178250 -
Placenta, Fetal Liver, Sectional Ductus Venosus Volumes Examined by Three-dimensional Ultrasound in the Second Trimester
|
N/A | |
Not yet recruiting |
NCT06310356 -
Continuous Glucose Monitoring for Women With Gestational Diabetes
|
N/A | |
Not yet recruiting |
NCT06445530 -
Nutrition Optimization and Community Upliftment for Postpartum Recovery
|
N/A | |
Recruiting |
NCT02590016 -
Glucose Control During Labour in Gestational Diabetes Mellitus With Insulin Treatment: A Randomized Controlled Trial
|
Phase 4 | |
Withdrawn |
NCT01947699 -
Glycemic Profile in Women With Gestational Diabetes Treated With Glyburide
|
Phase 4 | |
Not yet recruiting |
NCT00883259 -
Metformin and Gestational Diabetes in High-risk Patients: a RCTs
|
Phase 4 | |
Recruiting |
NCT03008824 -
Micronutrients in Pregnancy as a Risk Factor for Diabetes and Effects on Mother and Baby
|
N/A | |
Active, not recruiting |
NCT01340924 -
Relationship Between Gestational Diabetes and Type 2 Diabetes
|
||
Completed |
NCT00534105 -
Lipid Metabolism in Gestational Diabetes
|
N/A | |
Recruiting |
NCT00371306 -
Comparison of Glucovance to Insulin for Diabetes During Pregnancy
|
N/A | |
Completed |
NCT03388723 -
Intergenerational Programming of Diabesity in Offspring of Women With Gestational Diabetes Mellitus
|
||
Recruiting |
NCT04521712 -
Postpartum Glycemia in Women at Risk For Persistent Hyperglycemia
|
N/A | |
Enrolling by invitation |
NCT03307486 -
Gestational Diabetes: a Cohort Study
|
N/A | |
Active, not recruiting |
NCT03301792 -
Group Versus Traditional Prenatal Care for Diabetes
|
N/A | |
Enrolling by invitation |
NCT05603793 -
YoUng Adolescents' behaViour, musculoskeletAl heAlth, Growth & Nutrition
|