Strict glycemic control in VLBW infants at high risk of glycemic disorders using a Continuous Glucose Monitoring System: Randomized Controlled Clinical Trial

Strict glycemic control in VLBW infants at high risk of glycemic disorders using a Continuous Glucose Monitoring System: Randomized Controlled Clinical Trial - Strict glycemic control in VLBW using a CGMS: RCT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032812

Enrollment

Registered

2018-05-31

Start date

2018-06-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity

Interventions

Continuous glucose monitoring duration: at least 96h. Glucose infusion rate is modulated using a 33% glucose solution administered by a central line catheter. In the intervention group,62 mg/dl and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. VLBW infants fed with Parenteral Nutrition during the first week of life. 2. VLBW and Small for Gestational Age (SGA) infants with a documented prenatal history of severe placental insufficiency (umbilical doppler sonography assessing AED or ARED or brain sparing)

Exclusion criteria

Exclusion criteria: 1. Preterm infants with major congenital anomalies or chromosomic anomalies. 2. Infants not achieving a continuous glucose monitoring for more than 96 hours 3. Infants that need more than one replacement of the subcutaneous sensor

Design outcomes

Primary

Measure	Time frame
To achieve the reduction of 33% of dysglycemic episodes in the intervention arm.	—

Countries

Europe

Contacts

Public ContactAlessandro Perri

Catholic University of Sacred Heart, Department of Pediatrics Division of Neonatology

alessandro.perri@policlinicogemelli.it00390630154357

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026