NCT05037526

Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care in Pregnancy Outcomes

Diabetes in Pregnancy Project Und Mobile Health in Gestational Diabetes: An Open Label Randomized Controlled Monocentric Trial on the Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 302 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Once a pregnant mother is diagnosed with gestational diabetes mellitus (GDM), she will be treated with either diet, medication (i.e., insulin), or both. The most important factor in GDM management is glycemic control to reduce adverse outcomes. Blood glucose levels have become the "key player" for monitoring and directing treatment during pregnancy. Large trials have confirmed that treatment of GDM to optimize glycemic control can decrease the incidence of many of these associated adverse maternal and neonatal outcomes. Up to now, SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily. However, SMBG provides an incomplete picture of the daily glucose profile due to long intervals between finger pricking, and inaccurate self-reported measurements, which heavily rely on patients' compliance.

Detailed description

The incidence of obesity and diabetes is rising worldwide even in younger populations. With a rise in maternal obesity also gestational diabetes mellitus (GDM) becomes more prevalent with a prevalence of up to 18% of pregnancies. Up to now, SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily. The main purpose of this study is to prove that real time continuous glucose monitoring (rt-CGM) can effectively reduce the risk for adverse pregnancy and neonatal outcome in GDM. It is further hypothesized that rt-CGM can optimize maternal glycaemic control, increase patients satisfaction and adherence to management strategies of GDM. This is a open label randomized controlled trial with two parallel groups.

Conditions

• Gestational Diabetes

Interventions

Type	Name	Description
DEVICE	Dexcom G System	Continuous glucose monitoring system
DEVICE	Self monitoring blood glucose	Standard Care

Timeline

• Start date: 2021-09-24
• Primary completion: 2024-08-31
• Completion: 2024-10-30
• First posted: 2021-09-08
• Last updated: 2024-12-16

Locations

1 site across 1 country: Switzerland