Detecting Neonatal Hypoglycemia Using Real-Time Continuous Glucose Monitoring (CGM)

NCT03032523 | Completed Results

• 1 other identifier: 36668
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neonatal Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Sensor-detected Hypoglycemia

  Reported values in the table represent the cumulative number of hypoglycemic events detected by the sensor that were not detected by the hospital standard of care measures across all participants.

  up to 8 days

Secondary Outcomes (2)

• Sensitivity of the CGM to Detect Hypoglycemia.

  up to 7 days

• Specificity of CGM to Detect Hypoglycemic Events

  up to 7 days

Study Arms (2)

Remote Monitoring CGM Group

EXPERIMENTAL

Participants wear a CGM that is blinded at bedside (to participant and clinical staff) but remotely monitored by study staff. If a blood sugar less than 46 mg/dl occurs, the study staff receive a notification and ask the clinical staff to perform a confirmation standard of care glucose test.

Diagnostic Test: Standard of care glucose test

Blinded CGM Group

NO INTERVENTION

Participants wear a blinded CGM during the study period. Values are blinded to study staff, participant, and clinical staff.

Interventions

Standard of care glucose test DIAGNOSTIC_TEST

If the CGM in the remote monitoring group detects a blood sugar less than 46mg/dl, a confirmatory standard of care glucose test will be performed to confirm the low blood sugar.

Remote Monitoring CGM Group

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Limitations and Caveats

Because we were unable to recruit 40 infants during the time frame of the randomized trial, we modified the study design to test the additional benefit of using CGM monitoring to detect hypoglycemia.

Results Point of Contact

• Title: Laura Nally, MD, Instructor in Pediatrici Endocrinology
• Organization: Yale University

laura.nally@yale.edu

9728324734

Study Officials

• Laura Nally, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: January 26, 2017
• Study Start: October 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: July 29, 2019
• Results First Posted: July 29, 2019

Record last verified: 2019-07

Locations

US (1)