Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care in Pregnancy Outcomes
Key facts
- Who runs it
- Insel Gruppe AG, University Hospital Bern
- Where
- Switzerland1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 302 people enrolled
- Started
- 24 Sept 2021
- Ended
- 30 Oct 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Dexcom G System
- Self monitoring blood glucose
- Record updated
- 16 December 2024
Who can take part
- Age
- 18 years to 45 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- Participation in another study with investigational drug or product within the 30 days preceding and during the present study
- Chronic use of medications associated with hyperglycemia (steroids)
- 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
- Overt diabetes mellitus type 1 or 2
- History of bariatric surgery or other surgeries that induce malabsorption
- HbA1c by study entry > 6.5%
- Maternal age < 18 years,
- Multi-fetal gestations,
- Known fetal structural or chromosomal anomalies
- Planned preterm delivery
- Fetal growth restriction by study entry
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Dexcom G SystemExisting treatment, for comparison
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.
- Standard care of gestational diabetes with self monitoring blood glucose (SMBG)Existing treatment, for comparison
SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily.
Treatment: Self monitoring blood glucose
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Publications
- Continuous glucose monitoring in the management of gestational diabetes in Switzerland (DipGluMo): an open-label, single-centre, randomised, controlled trial.The lancet. Diabetes & endocrinology, 2025
- Record updated
- 16 December 2024