Neonatal HypoglycemiaNCT04458649
Continuous Glucose Monitoring in Infants
An observational study of Neonatal Hypoglycemia, run by University of California, San Diego at 1 site in United States.
Trial summary
The purpose of this study is to employ continuous glucose monitoring to measure glucose profiles in newborn infants. Read more about this study
- Who is it for?
- Ages 1 hour to 2 hoursHealthy volunteers can take part
- Conditions the study is for
- Neonatal Hypoglycemia
- What is being tested?
- Dexcom continuous glucose monitor
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 2 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Mother/infant dyads will be admitted at UCSD Jacobs Medical Center for antepartum and postpartum care.
Who may be able to join
- Mother at least 18 years of age
- Infants born either appropriate for gestational age (AGA) or large for gestational age (LGA)
- Skin fold over superior gluteus area at least 1 inch in thickness as measured by skin calipers
Who cannot join
- Infants born small for gestational age (SGA)
- Infant birth weight <2.5 kg
- Infant BMI <10th percentile on Olsen chart
- Infants born <38 weeks gestation
- Infants with concern for intrauterine growth restriction (IUGR) and short femur length based on ultrasound
- Mother is non-English speaking
Trial locations and contacts
1 site in 1 country.
Jane Kim, MD contact
United States1 site, 1 recruiting
- Recruiting
UCSD Medical Center
La Jolla, California, 92037
Valentina Stanley, BS, 858-966-4032, vstanley@health.ucsd.edu
Jane Kim, MD, 858-966-4032
About this study
The purpose of this study is to employ continuous glucose monitoring to measure glucose profiles in newborn infants.
Read the detailed description
We will place a continuous glucose monitor on the infant within 2 hours of birth and record blood glucose values every 5 minutes via the monitor; in addition, the infant will receive blood glucose checks via heel stick according to the standard hospital glucose monitoring protocol.
- Conditions
- Neonatal Hypoglycemia
- Being tested
- Dexcom continuous glucose monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom continuous glucose monitorDevice
Measurement of interstitial glucose
| Study group | Role | What they receive |
|---|---|---|
| No increased risk of hypoglycemia | Infants born with no obvious risk factors for hypoglycemia in the neonatal period. Receives: Device: Dexcom continuous glucose monitor | |
| Increased risk of hypoglycemia | Infants considered at increased risk for hypoglycemia after birth including the following criteria:
* Infant born to a diabetic mother
* Very large for gestational age (VLGA) infant with weight >97% Receives: Device: Dexcom continuous glucose monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent with glucose <40 mg/dL
The Dexcom continuous glucose monitors measure interstitial fluid glucose values every 5 minutes. Data obtained from the Dexcom tracings will allow us to quantify how much time both infants with no risk for hypoglycemia (defined here as <40 mg/dL) and those with risk factors for hypoglycemia spend at a blood glucose of <40 mg/dL.
Measured: The device will be worn from about 2 hours after birth until hospital discharge, up to a maximum of 10 days. It will be removed sooner if required for medical care or if the parent requests removal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Oct 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neonatal HypoglycemiaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Principal investigator, Dr Jane Kim, University of California, San Diego
- Investigators
- Jane Kim, MD, Principal investigator, University of California San Diego/Rady Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458649
- Sponsor's protocol ID
- 191263
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2020
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Thompson-Branch A, Havranek T. Neonatal Hypoglycemia. Pediatr Rev. 2017 Apr;38(4):147-157. doi: 10.1542/pir.2016-0063.
PubMed 28364046Adamkin DH. Neonatal hypoglycemia. Curr Opin Pediatr. 2016 Apr;28(2):150-5. doi: 10.1097/MOP.0000000000000319.
PubMed 26780301Straussman S, Levitsky LL. Neonatal hypoglycemia. Curr Opin Endocrinol Diabetes Obes. 2010 Feb;17(1):20-4. doi: 10.1097/MED.0b013e328334f061.
PubMed 19952738
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring in Infants
- ClinicalTrials.gov ID
- NCT04458649
- Acronym / sponsor ID
- 191263
- Conditions
- Neonatal Hypoglycemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to employ continuous glucose monitoring to measure glucose profiles in newborn infants.
Detailed description
We will place a continuous glucose monitor on the infant within 2 hours of birth and record blood glucose values every 5 minutes via the monitor; in addition, the infant will receive blood glucose checks via heel stick according to the standard hospital glucose monitoring protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No increased risk of hypoglycemia | – | Device: Dexcom continuous glucose monitorInfants born with no obvious risk factors for hypoglycemia in the neonatal period. |
| Increased risk of hypoglycemia | – | Device: Dexcom continuous glucose monitorInfants considered at increased risk for hypoglycemia after birth including the following criteria: * Infant born to a diabetic mother * Very large for gestational age (VLGA) infant with weight >97% |
Who may qualify
- Ages
- 1 hour to 2 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Mother/infant dyads will be admitted at UCSD Jacobs Medical Center for antepartum and postpartum care.
Key inclusion criteria (3 listed)
- Mother at least 18 years of age
- Infants born either appropriate for gestational age (AGA) or large for gestational age (LGA)
- Skin fold over superior gluteus area at least 1 inch in thickness as measured by skin calipers
Key exclusion criteria (6 listed)
- Infants born small for gestational age (SGA)
- Infant birth weight <2.5 kg
- Infant BMI <10th percentile on Olsen chart
- Infants born <38 weeks gestation
- Infants with concern for intrauterine growth restriction (IUGR) and short femur length based on ultrasound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexcom continuous glucose monitorMeasurement of interstitial glucose | Device | Increased risk of hypoglycemia, No increased risk of hypoglycemia |
Primary outcome
Time spent with glucose <40 mg/dL
Time frame: The device will be worn from about 2 hours after birth until hospital discharge, up to a maximum of 10 days. It will be removed sooner if required for medical care or if the parent requests removal.
The Dexcom continuous glucose monitors measure interstitial fluid glucose values every 5 minutes. Data obtained from the Dexcom tracings will allow us to quantify how much time both infants with no risk for hypoglycemia (defined here as <40 mg/dL) and those with risk factors for hypoglycemia spend at a blood glucose of <40 mg/dL.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 28364046Thompson-Branch A, Havranek T. Neonatal Hypoglycemia. Pediatr Rev. 2017 Apr;38(4):147-157. doi: 10.1542/pir.2016-0063.
- Background: PubMed 26780301Adamkin DH. Neonatal hypoglycemia. Curr Opin Pediatr. 2016 Apr;28(2):150-5. doi: 10.1097/MOP.0000000000000319.
- Background: PubMed 19952738Straussman S, Levitsky LL. Neonatal hypoglycemia. Curr Opin Endocrinol Diabetes Obes. 2010 Feb;17(1):20-4. doi: 10.1097/MED.0b013e328334f061.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Kim, MD contact
Jane Kim, MD principal investigator
University of California San Diego/Rady Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Hypoglycemia, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valentina Stanley, BS ((858) 249-5985, vstanley@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent with glucose <40 mg/dL (time frame: The device will be worn from about 2 hours after birth until hospital discharge, up to a maximum of 10 days. It will be removed sooner if required for medical care or if the parent requests removal.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04458649, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.