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Gestational Diabetes Mellitus in PregnancyCGMSGDMLABORNCT05067075

The CGMS in GDM Labor and Delivery Study

A study testing Blinded CGM in people with Gestational Diabetes Mellitus in Pregnancy, run by Woman's at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
Blinded CGM
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteUnited States
Study dates
1 Nov 2021to 18 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Woman's Hospital

    Baton Rouge, Louisiana, 70815

Other trials in United States

About this study

Official title: Role of Continuous Glucose Monitoring Systems (CGMS) for Intrapartum Metabolic Control in Gestational Diabetic (GDM)Women

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.

Read the detailed description

Planning management for a diabetic parturient during labor and delivery is particularly challenging because of the demands of labor, dietary restrictions, and potential for operative delivery. The main goals can be summarized as: ensuring the avoidance of maternal hypoglycemia or hyperglycemia (which can increase the risk of neonatal hypoglycemia), ensuring the safe use of measures to manage glycemic control, and the provision of effective analgesia for labor. Currently available international guidelines for the peripartum management of pregnant women with diabetes focus on rigorous intrapartum glycemic control. Maternal hyperglycemia in women with pregestational and gestational diabetes mellitus can cause hypoglycemia in the neonate following delivery. In women with diabetes, maternal hyperglycemia leads to hyperplasia of pancreatic β cells in the fetus and an increase in fetal insulin concentrations. When the continuous supply of glucose is stopped after delivery, the neonate is at risk of developing hypoglycemia, which if untreated can have serious neurological consequences. The increase in fetal insulin also contributes to the excess growth of the fetus in mothers with hyperglycemia. Avoiding intrapartum maternal hyperglycemia may prevent fetal hyperglycemia and reduce the likelihood of subsequent neonatal hypoglycemia. A further potential concern relates directly to the woman. Immediately after delivery, postpartum insulin requirements decrease dramatically as a result of the rapid decrease in diabetogenic placental hormone levels and resulting dissipation of pregnancy-induced insulin resistance. Pregnant women with diabetes may be at greater risk of hypoglycemic episodes because awareness of the symptoms of hypoglycemia is reduced, and this is further exacerbated by tight glycemic control .

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, and a high blood glucose level in the mother is associated with neonatal hypoglycemia. Continuous glucose monitoring (CGM) use appears to be safe and effective in pregnancies complicated by diabetes. Modern 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. CGM helps with treatment adjustments in pregnancies associated with diabetes. Strict glycemic control during labor and delivery may reduce the risk of neonatal hypoglycemia. In principle, "real-time" CGM might allow more rapid adjustment of insulin dosing and, thereby, yield better glycemic control than is possible with intermittent glucose monitoring. Two groups have reported on the use of CGM during labor in small pilot studies. Stenninger et al. reported that CGM was well tolerated in their 15 subjects and that elevated maternal glucose levels in the last 2 hours before delivery correlated with the need for intravenous glucose in the newborn. They found that multiple glycemic indices correlated positively with the need for neonatal intravenous glucose infusions. Iafusco et al. used real-time CGM in 14 subjects to guide insulin therapy during labor and found no cases of neonatal hypoglycemia. Another study looked at effects of maternal glucose levels in insulin-treated women during labor and delivery (2 to 8 hours before birth) and resultant neonatal hypoglycemia. In the this study, 45% (27/60) of women in the CGM group were compared with 100% (59/59) in the control group. Among women in the CGM arm, 10 infants developed hypoglycemia compared with 27 in the non-CGM group (37% vs. 46%, respectively; P = 0.45). 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.

Being tested
Blinded CGM
Keywords
continuous glucose monitoring, labor, post-delivery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blinded CGMDevice

    Also called Dexcom G6 Pro

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

Study groups in NCT05067075
Study groupRoleWhat they receive
Blinded CGMExperimentalBlinded continuous glucose monitor Dexcom G6Pro
Receives: Device: Blinded CGM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average percentage time in target glucose range

    average time in hours and minutes spent in target glucose range

    Measured: up to 10 days

Secondary outcomes (3)
  1. average time spent in hyperglycemia (time above target range)

    average time in hours and minutes spent with elevated blood sugar

    Measured: up to 10 days

  2. average time spent in hypoglycemia (time below target range)

    average time in hours and minutes spent with low blood sugar

    Measured: up to 10 days

  3. neonatal hypoglycemia

    Neonatal hypoglycemia is defined as a 2-hour plasma glucose value < 2.1 mmol/l (47 mg/dL taken 2 hours after delivery

    Measured: up to 2 hours post delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2021
  2. Study start1 Nov 2021
  3. Primary completion18 Apr 2023
  4. Study completion18 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
Blinded continuous glucose monitor will be compared with routine blood glucose monitoring
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05067075
Sponsor's protocol ID
RP-21-017
Acronym
CGMSGDMLABOR
Status last verified
Aug 2023
First submitted
22 Sep 2021
Last updated
28 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: The proposed research will involve a small sample (less than 65 subjects) recruited from clinical facilities at Woman's Hospital. Despite the removal of all identifiers, we believe that it would be difficult if not impossible to protect the identities of subjects. So even though the final dataset will be stripped of identifiers prior to release for sharing, we assume that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make the de- identified data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed

Publications

  • Elkind-Hirsch KE, Armatta M, Veillon E, Schiavon S, Cappon G. Relationship between continuous maternal intrapartum and postpartum glucose monitoring metrics and neonatal outcomes and postpartum glucose metabolism in individuals with gestational diabetes. BMC Pregnancy Childbirth. 2026 Mar 16;26(1):450. doi: 10.1186/s12884-026-08944-2.

    PubMed 41840522

Questions about this trial

What is this clinical trial studying?

A study testing Blinded CGM in people with Gestational Diabetes Mellitus in Pregnancy, run by Woman's at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average percentage time in target glucose range (time frame: up to 10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05067075, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.

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