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Can a glucose sensor improve control of sugar levels of premature babies in intensive care?

Real time continuous glucose monitoring in neonatal intensive care: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12793535
Enrollment
200
Registered
2015-05-15
Start date
2016-07-04
Completion date
Unknown
Last updated
2021-03-01

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

Conditions

Topic: Children

Interventions

Updated interventions as of 21/09/2018: Eligible babies are randomised within 24 hours of age through TENALEA (web based randomisation program) using a 1:1 ratio to either the treatmen

Sponsors

Cambridge University Hospitals NHS Foundation Trust
Lead Sponsor
University of Cambridge (UK)
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Parental consent 2. Less than or equal to 1200g birth weight 3. Less than or equal to 24 hours of age 4. Less than or equal to 33+6 weeks gestation 5. Male & Female 6. Upper Age Limit 1 days; Lower Age Limit 1 days

Exclusion criteria

Exclusion criteria: 1. A lethal congenital abnormality known at trial entry 2. Any congenital metabolic disorder known at trial entry 3. Neonates who, in the opinion of the treating clinician at trial entry, have no realistic prospect of survival

Design outcomes

Primary

MeasureTime frame
Percentage of time sensor glucose in target of 2.6-10mmol/l within the first 6 days of life in preterm infants—

Secondary

MeasureTime frame
1. Efficacy 2. Acceptability 3. Safety 4. Health economics—

Countries

Netherlands, Spain, United Kingdom

Contacts

Public ContactKathryn Beardsall
kb274@medschl.cam.ac.uk+44 (0)7565964631

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 24, 2026