The CGMS in GDM Labor and Delivery Study

NCT05067075 | Completed FDA Device

• 1 other identifier: RP-21-017
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Glucose control during labor is important for both fetus and mother. During labor and delivery, the goal is to maintain the sugars in the normal range as safely as possible as increased blood sugars 4-6 h prior to delivery leads to increased rates of hypoglycemia in the neonate. Neonatal hypoglycemia is a risk for the offspring of pregnant women with diabetes and occurs when fetal pancreatic hyperplasia is acutely stimulated by a high fetal glucose level derived from maternal hyperglycemia during labor. The maternal blood glucose level during delivery is a predictor of the neonatal blood glucose level. Modern continuous glucose monitoring (CGM) systems can capture the direction and magnitude of short-lived changes in interstitial glucose levels and are therefore useful for assessing glucose variability more accurately than self-monitoring blood glucose (SMBG) measurements. Indeed, it has already been demonstrated that intermittent blood glucose monitoring underestimates the number of hyperglycemic events, because blood glucose excursions can peak at different times of day. CGMs can help identify glycemic patterns in pregnancy, obtain and maintain glucose targets, and reduce hypoglycemia. Strict glycemic control during labor and delivery may reduce the risk of neonatal hypoglycemia. Two groups have reported on the use of CGM in type 1 diabetics during labor in small pilot studies. Another study looked at effects of maternal glucose levels in insulin-treated women during labor and delivery (2 to 8 h before birth) and resultant neonatal hypoglycemia. The researchers found that maternal hyperglycemia before delivery was correlated with neonatal hypoglycemia. Although more studies are needed, CGM use has promise as a therapy to improve outcomes in pregnancies associated with diabetes. In this study, the investigators plan to explore whether the use of blinded glucose monitoring during labor, delivery, and early postpartum supplementary to normally monitored plasma glucose measurements in women with gestational diabetes (GDM) would provide useful information to improve glycemia during labor in this diabetic population. All CGM data will be masked and therefore not available to participants, clinicians, or researchers at the time of delivery. Participants otherwise will receive standard clinical care. The blinded glucose monitoring data on glycemia throughout labor and post-delivery will be retrospectively assessed.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Keywords

continuous glucose monitoring; labor; post-delivery

Outcome Measures

Primary Outcomes (1)

• Average percentage time in target glucose range

  average time in hours and minutes spent in target glucose range

  up to 10 days

Secondary Outcomes (3)

• average time spent in hyperglycemia (time above target range)

  up to 10 days

• average time spent in hypoglycemia (time below target range)

  up to 10 days

• neonatal hypoglycemia

  up to 2 hours post delivery

Other Outcomes (1)

• postpartum 2 hour 75 gram OGTT results from mother

  from 6 to 12 weeks after delivery

Study Arms (1)

Blinded CGM

EXPERIMENTAL

Blinded continuous glucose monitor Dexcom G6Pro

Device: Blinded CGM

Interventions

Blinded CGM DEVICE

CGM that records blood glucose but is not visible to patient or provider in real-time

Also known as: Dexcom G6 Pro

Blinded CGM

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: participant must be pregnant and have gestational diabetes during current pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• singleton pregnancy
• a positive oral glucose tolerance test
• written informed consent
• labor scheduled for term induction (37-40 weeks)

You may not qualify if:

• prior diagnosis of type 1 or type 2 diabetes mellitus
• presence of infection
• Presence of significant systemic disease or other severe metabolic, endocrine, or medical co-morbidities
• History of bariatric surgery or other surgeries that induce malabsorption
• Long-term use (\>2 weeks) of systemic steroids prior to enrollment
• Multiple pregnancy
• Participants already using glucose lowering medications (metformin or insulin) for diabetes before study entry (can be used after diagnosis of GDM)
• Fetal growth restriction due to placental dysfunction or known congenital anomaly
• History of major depressive or other severe psychiatric disorders or inpatient psychiatric treatment up to 1 year before enrolment
• Inability or refusal to comply with protocol

Sponsors & Collaborators

• Woman's: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Woman's Hospital

Baton Rouge, Louisiana, 70815, United States

Location

Study Officials

• Karen Elkind-Hirsch, PhD

  Woman's Hospital, Louisiana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Blinded continuous glucose monitor will be compared with routine blood glucose monitoring

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 5, 2021
• Study Start: November 1, 2021
• Primary Completion: April 18, 2023
• Study Completion: April 18, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)