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NCT07462793: COMET-GDM
COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus (COMET-GDM): a Randomised Controlled Trial
NA trial testing Dexcom ONE Continuous Glucose Monitoring System in Neonatal Hypoglycemia in 120 participants. Not yet recruiting.
1 December 2027
Quick facts
| Lead sponsor | Institute of Mother and Child, Warsaw, Poland |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 1 March 2026 |
| Primary completion | 1 December 2027 |
| Estimated completion | 1 December 2027 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- Dexcom ONE Continuous Glucose Monitoring System
Conditions studied
- Neonatal Hypoglycemia — all drugs for Neonatal Hypoglycemia →
- Gestational Diabetes Mellitus (GDM) — all drugs for Gestational Diabetes Mellitus (GDM) →
Sponsor
Institute of Mother and Child, Warsaw, Poland
Who can join
Adults 1 Minute to 30 Minutes, any sex, with Neonatal Hypoglycemia or Gestational Diabetes Mellitus (GDM). Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Neonatal hypoglycaemia
Time frame: From birth until 72 hours of life
Number of hypoglycaemic episodes per neonate, defined as the number of CGM-recorded glucose values \<40mg/dl (2.2 mmol/L) occuring within the first 72 hours after birth.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07462793
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Neonatal Hypoglycemia
Currently open trials in the same condition.
- NCT07217483 — The Feasibility of Cream for Treatment of Neonatal Hypoglycemia · NA · recruiting
- NCT04458649 — Continuous Glucose Monitoring in Infants · recruiting
Other Institute of Mother and Child, Warsaw, Poland trials
Trials by the same sponsor.
- NCT07357857 — High Five! - School-based Prevention of Overweight and Obesity Among 6 to 9 Year Olds · NA · completed
- NCT06984445 — Cord Blood S100B Protein Levels in Neonates Following Intrauterine Transfusions for HDFN-Associated Fetal Anemia · recruiting
- NCT06893926 — Cord Blood S100B Protein Concentration in Neonates With Fetal Growth Restriction · recruiting
- NCT05395741 — Regorafenib in Patients With Refractory Primary Bone Tumors · Phase 1, PHASE2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07462793 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institute of Mother and Child, Warsaw, Poland
- Last refreshed: 8 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07462793.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing