A Novel Device for Gestational Diabetes Control

Launched by RAMBAM HEALTH CARE CAMPUS · Apr 2, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the LUMEN, which helps manage gestational diabetes mellitus (GDM) by providing personalized dietary and exercise recommendations based on your breathing. GDM is a common condition that occurs during pregnancy and can lead to health issues for both the mother and baby if not managed properly. The goal of the trial is to see if using the LUMEN device and app can result in better blood sugar control compared to using a regular mobile tracking app.

To be eligible for this study, women must be between 18 and 45 years old, currently pregnant with one baby, and diagnosed with GDM before 32 weeks of pregnancy. They should not be on any diabetes medications. Participants will need to monitor their blood sugar levels daily and attend regular follow-up appointments. After giving birth, the health outcomes of both the mother and baby will be recorded to measure how well the LUMEN device worked. This trial is not yet recruiting participants, but it aims to include around 170 women to see if the LUMEN can significantly reduce the need for insulin use.

Gender

FEMALE

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
• 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