eHealth in Treatment of Gestational Diabetes (eMOMGDM)

Gestational Diabetes Clinical Trial

— eMOMGDM  

Official title:

eHealth in Treatment of Gestational Diabetes - eMOM GDM -Study (Phase 2)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04714762
• Other study ID #: HUS/2165/2018-Phase 2
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 10, 2021
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

200 women with gestational diabetes will be randomized into the intervention and the control group at gestational week (GW) 24-28.

Participants in the intervention group will use the eMOM GDM -application one week/month until delivery.

The participants in the intervention and the control group visit study nurse 3 times in study period (at GW 24-28 and GW 35-37 and 3 months postpartum).

Both groups also receive regular antenatal care in maternity clinics and hospitals.

Maternal measurements at enrollment, and at 35-37 GW (both groups):

• Laboratory tests: fp-gluc, HbA1c, fp-insu, lipids, hs-CRP

• Fingertips glucose values from glucose meter (belong to normal antenatal care)

• Fasting blood samples for future analyses

• Weight, height, blood pressure (from the antenatal registry and study visits)

• Questionnaires: background (only at enrollment), diet (food frequency questionnaire), depression (EPDS), motivation (TSRQ+PCS), quality of life (15D)

• Physical activity and sedentary behavior with the hip-worn triaxial accelerometer (UKK RM 42)

• Physical activity and heart rate with Firstbeat Bodyguard

Measurements at Birth:

• Cord blood sample

• Placental weight

• Offspring birthweight, height, body composition (PEA POD Cosmed®)

Maternal measurements at 3 months postpartum:

• Laboratory tests: fp-gluc, HbA1c, fp-insu, lipids, hs-CRP

• fp-gluc, 2h postprandial value, as measured during oral glucose tolerance test (OGTT)

• Fasting blood samples for future analyses

• Firstbeat Bodyguard 2 measurement (3 days)

• Depression questionnaire (EPDS)

• Diet questionnaire (FFQ)

Protocol only for the intervention group

• eMOM GDM application: use: 1 application week + 3 normal care weeks repeatedly until delivery

The application includes:

1. continuous glucose monitor (CGM)

• fingertips glucose calibration according to CGM protocol (twice per day with Medtronic)

2. diet (digital food tracker)

• 3 days during one application week

• For ensuring the quality of food record a researcher will phone interview the participant based on her recordings. This is done after each recording period.

3. heartrate, stress and physical activity with the wrist-worn activity tracker (Vivosmart 3)

4. weight measured once a week

Data from the sensors

• Data from users' input to the application

• Technology acceptance questionnaire (UTAUT) after every application week

• Usability questionnaire, after four weeks usage of the eMOM GDM application

• Semi-structured interview

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Mobile Application

Intervention

Device:
• eMOM GDM application
Participants in the intervention group will use the eMOM GDM -application one week/month. eMOM GDM application includes: continuous glucose monitor (CGM, Medtronic) diet (digital food tracker) (min 3 days during one application week) heartrate, stress and physical activity with the wrist-worn activity tracker (Vivosmart 3) weight measured once a week The sensors can be worn and the application used during the whole pregnancy (if a mother is interested in)

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki

Sponsors (9)

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

Country where clinical trial is conducted

Finland, 

Outcome

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