N/A
Completed N=21
Detecting Neonatal Hypoglycemia Using Real-Time Continuous Glucose Monitoring (CGM)
Neonatal Hypoglycemia
Source: ClinicalTrials.gov NCT03032523 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Sensor-detected Hypoglycemia — 5; 1 events
Summary
Hypoglycemia is the most common metabolic problem faced after birth. The investigators will be studying the utility of using a continuous glucose monitoring(CGM) system to more closely monitor low blood sugars in newborns. The investigators will evaluate the number of hypoglycemic events detected using CGM and compare it to those detected using current standard of care screening methods.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensor-detected Hypoglycemia |
5; 1 | — |
| SECONDARY Sensitivity of the CGM to Detect Hypoglycemia. |
86 | — |
| SECONDARY Specificity of CGM to Detect Hypoglycemic Events |
91 | — |
Eligibility Criteria
Inclusion Criteria
- Infants who are at least 34 weeks gestation that are born to mothers with gestational or pre-gestational diabetes and are admitted to LPCH are eligible for the study.
Exclusion Criteria
- Infants <2, 000 grams will be excluded from the study. Infants will also be excluded if they have an anomaly of the skin or subcutaneous tissue that would prevent proper adhesion, placement, and function of the sensor.
Data sourced from ClinicalTrials.gov (NCT03032523). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.