Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes (SMART-GDM)
Gestational Diabetes, Pregnancy Complications, Weight Gain
About this trial
This is an interventional supportive care trial for Gestational Diabetes focused on measuring Gestational Diabetes, RCT, Lifestyle coaching program, Smartphone app, Gestational weight gain
Eligibility Criteria
Inclusion Criteria:
- Ability to provide informed consent.
- Women aged 21 years and older.
- Singleton pregnancy.
- GDM diagnosed between 12 to 30 weeks of gestation, based on the 2013 World Health Organization (WHO) criteria, i.e. either of the following: fasting plasma glucose ≥5.1 mmol/L, 60-minute plasma glucose ≥10.0 mmol/L, 120-minute plasma glucose ≥8.5 mmol/L, during a 75g oral glucose tolerance test (OGTT).
- Possesses a smartphone and ability to navigate a smartphone app.
- Proficient in English language.
- Plan to deliver the baby in National University Hospital.
Exclusion Criteria:
- Multiple pregnancy.
- Pre-existing diabetes (type 1 diabetes, type 2 diabetes, or other specific types of diabetes) diagnosed prior to current pregnancy.
- GDM diagnosed before 12 weeks of gestation.
- No weight available in first trimester (at or before 12 weeks gestation) of the pregnancy.
- Need for insulin therapy from the start of diagnosis of GDM, as determined by the primary clinician.
- Heart failure.
- Chronic kidney disease
- Feeding and eating disorders.
- History of bariatric surgery.
- Long-term systemic corticosteroids use.
- Impaired mobility.
- Concomitant participation in another clinical study (i.e. Phase I-III clinical studies) with investigational medicinal product(s).
Sites / Locations
- National University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intervention
Control
Patients in the intervention arm will receive standard medical care and in addition to that, be given the Aina or Aina Mini device for self-monitoring of blood glucose (SMBG), the Habits-GDM mobile app, and a weighing scale.
Patients in the control arm will receive standard medical care and only be given the Aina or Aina Mini device for SMBG. Standard medical care involves one session of face-to-face education by a diabetes nurse educator and a dietician. Patients are initiated on capillary glucose monitoring. Subsequently, standard clinical care is provided by their obstetrician. Participation in this study will not increase the frequency of clinic visits. The frequency of SMBG will be as clinically indicated and not increased as a result of participation in this study. Should the obstetrician feels that insulin is required, it will be initiated and if necessary the patient will be referred to the endocrinology service for management of insulin therapy. In some patients, the clinician may decide to prescribe metformin.