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

Gestational Diabetes Clinical Trial

— DiP GlucoMo  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05037526
• Other study ID #: UCB_GDMV4.0
• Status: Recruiting
• Phase: N/A
• Start date: September 24, 2021
• Est. completion date: March 1, 2024

Study information

• Verified date: September 2022
• Source: University Hospital Inselspital, Berne
• Contact: Sofia Amylidi-Mohr, MD
• Phone: +41 31 632 1010
• Email: sofia.mohr[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 302
• Est. completion date: March 1, 2024
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Device:
• Dexcom G System
Continuous glucose monitoring system
• Self monitoring blood glucose
Standard Care

Locations

Country	Name	City	State
Switzerland	University Hospital of Bern, Inselspital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (6)

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, Kor — View Citation

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 — View Citation

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 an — View Citation

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; CONCEPT — View Citation

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):1281-12 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Initiated Therapy	Need for antiglycemic therapy in example Insulin yes/no	10-14 weeks
Secondary	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
Secondary	Glycemic Outcomes 2	Time in glucose target in %	10-14 weeks
Secondary	Glycemic Outcomes 3	Duration and frequency postprandial hyperglycaemic excursions	10-14 weeks
Secondary	Glycemic Outcomes 4	Hemoglobin A1c (HbA1c) values (at inclusion, birth and postpartum) in %	10-14 weeks
Secondary	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
Secondary	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
Secondary	Need for induction of labor	Induction of labor yes/no	10-14 weeks
Secondary	Obstetrical outcome	Obstetric injury yes/no	10-14 weeks
Secondary	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
Secondary	Maternal weight gain	Weight gain after GDM diagnosis in kg	10-14 weeks
Secondary	Maternal Compliance	Adherence to therapy yes/no	10-14 weeks
Secondary	Maternal satisfaction questionnaire	Patient satisfaction after pregnancy evaluated through a questionnaire	10-14 weeks
Secondary	Postpartum disorder	8 weeks postpartum oral glucose test values in mmol/L	10-14 weeks
Secondary	Birth age	Gestational age at delivery in weeks	10-14 weeks
Secondary	Preterm	Preterm delivery (delivery < 37 weeks gestational age) yes/no	10-14 weeks
Secondary	Neonatal weight	Birth weight in grams	10-14 weeks
Secondary	Neonatal outcome	Small for gestational age (birth weight < 10%) yes/no	10-14 weeks
Secondary	Neonatal condition	Poor condition at birth (Apgar score at 5 minutes <7, Arterial pH of <7.0) yes/no	10-14 weeks
Secondary	Neonatal Morbidity	Perinatal morbidity prior to hospital discharge.	10-14 weeks
Secondary	Neonatal birth trauma	Birth trauma (brachial plexus injury, or clavicular, humeral, or skull fracture)	10-14 weeks
Secondary	Resuscitation	Need for resuscitation yes/no	10-14 weeks
Secondary	Neonatal Care	Admission to neonatal intensive care unit (NICU) with length of stay in days	10-14 weeks
Secondary	Respiratory distress syndrome	Respiratory distress syndrome (need for supplemental oxygen > 4 hours after birth) yes/no	10-14 weeks