Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:33 AM
Study NCT ID:
NCT07462793
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus
Sponsor:
Institute of Mother and Child, Warsaw, Poland
Organization:
Study Overview
Official Title:
COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus (COMET-GDM): a Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMET-GDM
Brief Summary:
The purpose of this study is to determine whether continuous glucose monitoring (CGM) improves the detection and management of neonatal hypoglycaemia in newborns of mothers with insulin-treated gestational diabetes.
Detailed Description:
Gestational diabetes mellitus (GDM) is a form of glucose intolerance affecting up to 14% of pregnant women and is associated with an increased risk of multiple maternal and fetal complications. This risk is proportional to the degree of maternal hyperglycaemia. Appropriate glycaemic control and dietary management are key components of GDM treatment. However, in approximately 10-30% of cases, pharmacological therapy is required, due to persistent fasting hyperglycaemia.
Neonatal hypoglycaemia is one of the most common metabolic complications associated with GDM, affecting approximately 5-15% of newborns, and is linked to increased morbidity. There is currently no universal consensus regarding the lowest safe blood glucose threshold required to prevent neurological complications in this population. Nevertheless, persistent or recurrent hypoglycaemia, that is unresponsive to treatment is known to be associated with adverse neurological outcomes.
Following birth and umbilical cord clamping, the newborn must maintain glucose homeostasis through endogenous production via glycogenolysis and gluconeogenesis, as well as through enteral feeding. This physiological transition results in lower blood glucose concentrations during the first 4 hours of life and increases the risk of neonatal hypoglycaemia. Furthermore, in pregnancies complicated by insulin-treated GDM, chronic maternal hyperglycaemia leads to hypertrophy of the fetal pancreatic islets and fetal hyperinsulinaemia, which further increases the risk of hypoglycaemia after birth.
Current clinical guidelines rely on intermittent capillary blood glucose measurements performed at predetermined intervals. However, this scheduled testing approach may fail to detect transient hypoglycaemic episodes.
Continuous glucose monitoring (CGM) enables continuous measurement of interstitial glucose concentrations. Despite its potential advantages, there is limited evidence regarding the clinical significance of CGM use in neonates born to mothers with insulin-treated gestational diabetes.
The aim of this study is to determine whether CGM improves the detection and management of neonatal hypoglycaemia in newborns of mothers with insulin-treated gestational diabetes. This study is designed as a single-centre, randomised controlled trial conducted at the Department of Neonatology and Neonatal Intensive Care, Institute of Mother and Child, Warsaw, Poland.
In the intervention group (CGM group), glucose concentrations will be monitored using CGM. Routine scheduled capillary blood glucose measurements will not be performed unless clinically indicated.
In the control group (standard monitoring group), glucose concentrations will be measured using capillary blood glucose testing in accordance with the local standard protocol. A CGM sensor will also be applied; however, glucose recordings will be masked to both clinical staff and parents.
In both groups, CGM will continuously collect glucose data for the first 72 hours after birth.
Neonatal hypoglycaemia is one of the most common metabolic complications associated with GDM, affecting approximately 5-15% of newborns, and is linked to increased morbidity. There is currently no universal consensus regarding the lowest safe blood glucose threshold required to prevent neurological complications in this population. Nevertheless, persistent or recurrent hypoglycaemia, that is unresponsive to treatment is known to be associated with adverse neurological outcomes.
Following birth and umbilical cord clamping, the newborn must maintain glucose homeostasis through endogenous production via glycogenolysis and gluconeogenesis, as well as through enteral feeding. This physiological transition results in lower blood glucose concentrations during the first 4 hours of life and increases the risk of neonatal hypoglycaemia. Furthermore, in pregnancies complicated by insulin-treated GDM, chronic maternal hyperglycaemia leads to hypertrophy of the fetal pancreatic islets and fetal hyperinsulinaemia, which further increases the risk of hypoglycaemia after birth.
Current clinical guidelines rely on intermittent capillary blood glucose measurements performed at predetermined intervals. However, this scheduled testing approach may fail to detect transient hypoglycaemic episodes.
Continuous glucose monitoring (CGM) enables continuous measurement of interstitial glucose concentrations. Despite its potential advantages, there is limited evidence regarding the clinical significance of CGM use in neonates born to mothers with insulin-treated gestational diabetes.
The aim of this study is to determine whether CGM improves the detection and management of neonatal hypoglycaemia in newborns of mothers with insulin-treated gestational diabetes. This study is designed as a single-centre, randomised controlled trial conducted at the Department of Neonatology and Neonatal Intensive Care, Institute of Mother and Child, Warsaw, Poland.
In the intervention group (CGM group), glucose concentrations will be monitored using CGM. Routine scheduled capillary blood glucose measurements will not be performed unless clinically indicated.
In the control group (standard monitoring group), glucose concentrations will be measured using capillary blood glucose testing in accordance with the local standard protocol. A CGM sensor will also be applied; however, glucose recordings will be masked to both clinical staff and parents.
In both groups, CGM will continuously collect glucose data for the first 72 hours after birth.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 42/2025 | OTHER | Bioethics Committee at Institute of Mother and Child, Warsaw, Poland | View |