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

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

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes
• Intervention / Treatment: Device: Dexcom G System; Device: Self monitoring blood glucose

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.

• Study Type: Interventional
• Enrollment (Actual): 302
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • University Hospital of Bern, Inselspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexcom G System; 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.	Device: Dexcom G System; Continuous glucose monitoring system
Active Comparator: Standard care of gestational diabetes with self monitoring blood glucose (SMBG); SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily.	Device: Self monitoring blood glucose; Standard Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite adverse pregnancy and neonatal outcome	The primary endpoint is composite adverse pregnancy and neonatal outcome; the proportion of large for gestation age (LGA) newborns (birth weight >90th centile); fetal macrosomia (estimated fetal weight over the 95th centile); incidence of polyhydramnios (maximal vertical pocket ≥ 8 cm); rate of neonatal hypoglycaemia; occurrence of stillbirth. Every each and one of these variables contributes to a better neonatal outcome and are associated. This composite endpoint includes factors influencing decisive the neonatal outcome.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initiated Therapy	Need for antiglycemic therapy in example Insulin yes/no	10-14 weeks
Glycemic Outcomes 1	Glycemic variability including number and duration of hypoglycemic and hyperglycemic events, mean interstitial glucose in mmol/L and its standard deviation (SD) A hypoglycemic event was defined for two separate analyses as excursions of at least 15 min below the target range (<3.5 mmol/L), and a hyperglycemic event was defined for two separate analyses as excursions of at least 15 min above the target range (>7.8 mmol/L).	10-14 weeks
Glycemic Outcomes 2	Time in glucose target in %	10-14 weeks
Glycemic Outcomes 3	Duration and frequency postprandial hyperglycaemic excursions	10-14 weeks
Glycemic Outcomes 4	Hemoglobin A1c (HbA1c) values (at inclusion, birth and postpartum) in %	10-14 weeks
Pregnancy complications	Pregnancy Complications such as; Placenta insufficiency (Estimated fetal weight < 10th centile and blood flow changes),; Gestational hypertension (systolic blood pressure ≥ 140 mm Hg or diastolic blood pressure ≥ 90 mg Hg on two occasions at least 4 hours apart); Preeclampsia (international Society for the Study of Hypertension in Pregnancy (ISSHP) definition)	10-14 weeks
Mode of Delivery	Mode of delivery including cesarean delivery, induction of labor, need for operative vaginal delivery (forceps or vacuum-assisted vaginal delivery)	10-14 weeks
Need for induction of labor	Induction of labor yes/no	10-14 weeks
Obstetrical outcome	Obstetric injury yes/no	10-14 weeks
Maternal outcomes	Body mass index (BMI) (pre-pregnancy and at the time of delivery) weight and height will be combined to report BMI in kg/m^2	10-14 weeks
Maternal weight gain	Weight gain after GDM diagnosis in kg	10-14 weeks
Maternal Compliance	Adherence to therapy yes/no	10-14 weeks
Maternal satisfaction questionnaire	Patient satisfaction after pregnancy evaluated through a questionnaire	10-14 weeks
Postpartum disorder	8 weeks postpartum oral glucose test values in mmol/L	10-14 weeks
Birth age	Gestational age at delivery in weeks	10-14 weeks
Preterm	Preterm delivery (delivery < 37 weeks gestational age) yes/no	10-14 weeks
Neonatal weight	Birth weight in grams	10-14 weeks
Neonatal outcome	Small for gestational age (birth weight < 10%) yes/no	10-14 weeks
Neonatal condition	Poor condition at birth (Apgar score at 5 minutes <7, Arterial pH of <7.0) yes/no	10-14 weeks
Neonatal Morbidity	Perinatal morbidity prior to hospital discharge.	10-14 weeks
Neonatal birth trauma	Birth trauma (brachial plexus injury, or clavicular, humeral, or skull fracture)	10-14 weeks
Resuscitation	Need for resuscitation yes/no	10-14 weeks
Neonatal Care	Admission to neonatal intensive care unit (NICU) with length of stay in days	10-14 weeks
Respiratory distress syndrome	Respiratory distress syndrome (need for supplemental oxygen > 4 hours after birth) yes/no	10-14 weeks

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Sofia Amylidi-Mohr, MD, Uniuversity Hospital and University of Bern

Publications and helpful links

General Publications

• Castorino K, Polsky S, O'Malley G, Levister C, Nelson K, Farfan C, Brackett S, Puhr S, Levy CJ. Performance of the Dexcom G6 Continuous Glucose Monitoring System in Pregnant Women with Diabetes. Diabetes Technol Ther. 2020 Dec;22(12):943-947. doi: 10.1089/dia.2020.0085.
• Cosson E, Baz B, Gary F, Pharisien I, Nguyen MT, Sandre-Banon D, Jaber Y, Cussac-Pillegand C, Banu I, Carbillon L, Valensi P. Poor Reliability and Poor Adherence to Self-Monitoring of Blood Glucose Are Common in Women With Gestational Diabetes Mellitus and May Be Associated With Poor Pregnancy Outcomes. Diabetes Care. 2017 Sep;40(9):1181-1186. doi: 10.2337/dc17-0369. Epub 2017 Jul 19.
• Inayama Y, Yamanoi K, Shitanaka S, Ogura J, Ohara T, Sakai M, Suzuki H, Kishimoto I, Tsunenari T, Suginami K. A novel classification of glucose profile in pregnancy based on continuous glucose monitoring data. J Obstet Gynaecol Res. 2021 Apr;47(4):1281-1291. doi: 10.1111/jog.14677. Epub 2021 Jan 27.
• Polsky S, Garcetti R, Pyle L, Joshee P, Demmitt JK, Snell-Bergeon JK. Continuous glucose monitor use with and without remote monitoring in pregnant women with type 1 diabetes: A pilot study. PLoS One. 2020 Apr 16;15(4):e0230476. doi: 10.1371/journal.pone.0230476. eCollection 2020.
• Battelino T, Danne T, Bergenstal RM, Amiel SA, Beck R, Biester T, Bosi E, Buckingham BA, Cefalu WT, Close KL, Cobelli C, Dassau E, DeVries JH, Donaghue KC, Dovc K, Doyle FJ 3rd, Garg S, Grunberger G, Heller S, Heinemann L, Hirsch IB, Hovorka R, Jia W, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Levine B, Mayorov A, Mathieu C, Murphy HR, Nimri R, Norgaard K, Parkin CG, Renard E, Rodbard D, Saboo B, Schatz D, Stoner K, Urakami T, Weinzimer SA, Phillip M. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care. 2019 Aug;42(8):1593-1603. doi: 10.2337/dci19-0028. Epub 2019 Jun 8.
• Feig DS, Donovan LE, Corcoy R, Murphy KE, Amiel SA, Hunt KF, Asztalos E, Barrett JFR, Sanchez JJ, de Leiva A, Hod M, Jovanovic L, Keely E, McManus R, Hutton EK, Meek CL, Stewart ZA, Wysocki T, O'Brien R, Ruedy K, Kollman C, Tomlinson G, Murphy HR; CONCEPTT Collaborative Group. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. Lancet. 2017 Nov 25;390(10110):2347-2359. doi: 10.1016/S0140-6736(17)32400-5. Epub 2017 Sep 15. Erratum In: Lancet. 2017 Nov 25;390(10110):2346. doi: 10.1016/S0140-6736(17)32712-5.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2021
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes, Gestational; Diabetes Mellitus
• Other Study ID Numbers: UCB_GDMV4.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No