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

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Gestational Diabetes

Treatments: Device: Dexcom G System; Device: Self monitoring blood glucose

Study type: Interventional

Funder types: Other

Identifiers

NCT05037526

UCB_GDMV4.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 302 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed Consent as documented by signature
• GDM diagnosis between 24 0/7- 28 0/7 weeks of pregnancy by a 75g oral glucose test (oGTT)
• Maternal age of 18 to 45 years,
• Singleton gestation
• Gestational age ≥ 24 0/7 weeks and <32 0/7 weeks at enrollment.

Exclusion criteria

• Known hypersensitivity or allergy to the sensor
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders of the participant
• Participation in another study with investigational drug or product within the 30 days preceding and during the present study
• Maternal age < 18 years,
• Multi-fetal gestations,
• Known fetal structural or chromosomal anomalies
• Chronic use of medications associated with hyperglycemia (steroids)
• Planned preterm delivery
• Overt diabetes mellitus type 1 or 2
• HbA1c by study entry > 6.5%
• History of bariatric surgery or other surgeries that induce malabsorption
• Fetal growth restriction by study entry

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

302 participants in 2 patient groups

Dexcom G System

Active Comparator group

Description:

The Dexcom G6 or current version intended use is for the management of diabetes. It is a small flexible device that records interstitial glucose levels every 5 min and is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 or current version System results should be based on the glucose trends and several sequential readings over time. The system consists of a sensor, transmitter, receiver and mobile app.

Treatment:

Device: Dexcom G System

Standard care of gestational diabetes with self monitoring blood glucose (SMBG)

Active Comparator group

Description:

SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily.

Treatment:

Device: Self monitoring blood glucose