Objective The aim of the study is to examine the effect of using Lumen on metabolic parameters and anthropometric variables in patients with gestational diabetes mellitus. Aims and hypotheses Primary aim: To evaluate the rate of progression from GDM-A1 to GDM-A2 between the groups.
Secondary aim: To evaluate the efficacy of Lumen on metabolic parameters, obstetric outcomes, and neonatal outcomes. Hypothesis: the investigators expect that using Lumen would reduce the rate of progression from GDM-A1 to GDM- A2. Methods Design This will be an open label parallel group 1:1 randomized-controlled trial. Participants The study will include up to 170 women diagnosed with GDM. GDM will be defined according to current ACOG (The American College of Obstetricians and Gynecologists) guidelines. A positive glucose challenge test at 24-28 weeks' gestation followed by at least two pathological values in oral glucose challenge or one pathological value and at least one additional risk factor for GDM (a first family member diagnosed with type 2 DM, obesity, history of GDM).
Women in both groups it will use a glucometer and will be instructed in the use of the device. Use will include puncture of the fingertip to obtain a drop of blood and use of a suitable probe to obtain a sugar measurement.
Eligibility criteria
Inclusion criteria:
1. Gravidas aged 18-45 years
2. Singleton pregnancy
3. Diagnosed with GDM in current pregnancy
4. First visit to high-risk pregnancy clinic is no late than 32 weeks' gestation
5. Not treated with diabetes-related medications
Exclusion criteria:
Medications:
1. Insulin and medications for glycemic control
2. Antipsychotics
3. Diuretics
4. Corticosteroids
5. Oncologic treatment
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Conditions:
1. Previous diagnosis of diabetes
2. Renal disease
3. Hepatic disease
Personal requirements:
1. Inability to read and understand English
2. Inability to use a smartphone
3. Any issues arise with using the Lumen device and application
4. Aerobic exercise \> 3 times per week Recruitment Women with GDM will be recruited via clinical referrals from the feto-maternal outpatient clinic or the feto-maternal unit in Rambam medical center (RMC) Intervention All the participants will be under regular follow-up of the treating obstetrician in the feto-maternal outpatient clinic. After the diagnosis of GDM the patients (of both groups) will be instructed regarding recommended diet and glucose monitoring as accustomed in our department. After randomization to the lumen group, subjects will use the Lumen device and mobile phone application, which will guide them once a day after the night fast regarding their daily diet, sleep, and routines according to their Lumen measurements. Subjects will need Google Fit (Android) or Apple Health Kit (iOS) and will be encouraged to communicate with a study investigator via the app during the entirety of the study to resolve technical questions about the device and data collection. The control group will use the glucose buddy app and will be managed in accordance with the common guidelines for GDM management. Participants of both group will measure their fating blood glucose levels and their postprandial blood glucose levels and record it in their mobile app.
