Effectiveness of CGMS Vs. Self-monitoring Blood Glucose (SMBG) in Woman with Gestational Diabetes

NCT04948112 | Completed FDA Device

• 1 other identifier: RP-21-012
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

The detection of and control of gestational diabetes carries benefits for both mother and baby related to immediate pregnancy outcomes. The glycemic disorders in diabetes are not solely limited to fasting and postprandial hyperglycemia, but can be extended to the glycemic variability that includes both upward (postprandial glucose increments) and downward (interprandial glucose decrements) changes. Glycemic variability, as a component of the glycemic disorders, has more deleterious effects than sustained chronic hyperglycemia in the development of diabetic complications. Glycemic variability is associated with increased risks of adverse pregnancy outcomes in GDM. Hyperglycemic excursion has been shown to be the strongest predictor of macrosomia, the most common complication of pregnancy with diabetes. When compared with routine standard antenatal care, continuous glucose monitoring system (CGMS) guided treatments should significantly improve glycemic control, lower infant birth weight, and reduce risk of macrosomia in gestational women with diabetes. We will investigate the following questions (1) Whether CGMS can detect greater glycemic variability in women with an early GDM diagnosis; (2) Whether CGMS can subsequently moderate treatment strategies of GDM especially patient behavior and glucose levels; (3) Whether CGMS can eventually improve maternal (i.e., reduce gestational weight gain and lower glycemic levels during pregnancy) and fetal outcomes (reduce LGA babies and C-section rate) compared with traditional self-monitored blood glucose (SMBG) use.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Keywords

continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• Average percent time in glucose range

  average time in hours and minutes spent in target glucose range

  up to 32 weeks

Secondary Outcomes (6)

• time spent in hyperglycemia (time above range)

  up to 32 weeks

• time spent in hypoglycemia (time below range)

  up to 32 weeks

• percent weight gain during pregnancy

  through study completion, an average of 38 weeks

• HbA1c

  through study completion, an average of 38 weeks

• Large-for -gestational age newborns

  at time of delivery

Other Outcomes (2)

• CGM-satisfaction (CGM SAT) survey

  immediately after delivery

• Perceived benefit questionnaire (GMS)

  immediately after delivery

Study Arms (2)

Real-time (rt) CGMS with SMBG

EXPERIMENTAL

Real time continuous glucose monitoring plus self-monitored blood glucose

Device: real time continuous glucose monitor

SMBG with blinded CGM

ACTIVE COMPARATOR

Self monitored blood glucose with blinded continuous glucose monitoring

Device: blinded continuous glucose monitor

Interventions

real time continuous glucose monitor DEVICE

CGM sensor will read blood glucose every 10 minutes

Also known as: Dexcom G6

Real-time (rt) CGMS with SMBG

blinded continuous glucose monitor DEVICE

CGM that records blood glucose but not visible to patient

Also known as: blinded Dexcom

SMBG with blinded CGM

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: must be pregnant
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 8-26 weeks gestation
• singleton pregnancy,
• a positive oral glucose tolerance test
• written informed consent.

You may not qualify if:

• prior diagnosis of diabetes mellitus,
• presence of infection,
• Presence of significant systemic disease or other severe metabolic, endocrine, medical co-morbidities
• history of bariatric surgery or other surgeries that induce malabsorption
• long-term use (\>2 weeks) of systemic steroids prior to enrolment
• multiple pregnancy
• patients already using glucose lowering medications (metformin or insulin) before study entry
• fetal growth restriction due to placental dysfunction at study entry
• History of major depressive or other severe psychiatric disorders or inpatient psychiatric treatment up to 1year before enrolment
• Inability or refusal to comply with protocol
• Currently participating or having participated in an experimental study in previous three months

Sponsors & Collaborators

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

Study Sites (1)

Karen Elkind-Hirsch

Baton Rouge, Louisiana, 70817, United States

Location

Study Officials

• Karen Elkind-Hirsch, PhD

  Woman's Hospital, Louisiana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 1, 2021
• Study Start: October 1, 2021
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

US (1)