HyperinsulinismNCT06363929
Continuous Glucose Monitoring in Neonatal Hyperinsulinism
An observational study of Hyperinsulinism and Hypoglycemia Neonatal, run by MemorialCare Health System at 1 site in United States.
Trial summary
The investigators are studying the accuracy of Dexcom G6 continuous glucose monitors placed on babies with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit. The participants will wear the device for 10 days on their lateral thigh. Read more about this study
- Who is it for?
- Ages 24 hours to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Hyperinsulinism, Hypoglycemia Neonatal
- What is being tested?
- Dexcom G6 continuous glucose monitor
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 22 Sep 2025
- 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 24 hours to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Neonates with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit
Who may be able to join
- Age: 0-90 days old
- Gestational Age: > 28 weeks gestational age
- Diagnosis of hyperinsulinism based on critical sample and/or glucagon challenge
Who cannot join
- Diffuse skin disease such that placement of a Dexcom G6 sensor would be difficult to secure
- Infants colonized or infected with multi-drug resistant organisms (i.e. MRSA, VRE, ESBL producing bacteria)
- Infants on hypothermic protocols
- Infants expected to remain in the NICU <24 hours
- Infants enrolled in a competing clinical trial
- Family/team have decided to limit or redirect from aggressive NICU technological support
- Ward of the state
Trial locations and contacts
1 site in 1 country.
United States1 site
Miller Children's Hospital
Long Beach, California, 90806
About this study
Official title: A Study to Evaluate the Accuracy of Continuous Glucose Monitors in Neonates With Hyperinsulinism.
The investigators are studying the accuracy of Dexcom G6 continuous glucose monitors placed on babies with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit. The participants will wear the device for 10 days on their lateral thigh. Whenever blood sugars are checked by glucometer, the investigators will also record the continuous glucose monitor sugar. Additionally, if the continuous glucose monitor alarms for a low sugar or an impending low sugar, the investigators will check the blood sugar by glucometer and, if verified to be low, treat the low blood sugar accordingly.
- Conditions
- Hyperinsulinism, Hypoglycemia Neonatal
- Being tested
- Dexcom G6 continuous glucose monitor
- Medical subject headings
- Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom G6 continuous glucose monitorDevice
Dexcom G6 continuous glucose monitor to be placed on neonates with hyperinsulinism for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Neonates with hyperinsulinism | Neonates with a diagnosis of hyperinsulinism will wear a Dexcom G6 continuous glucose monitor placed for 10 days. Receives: Device: Dexcom G6 continuous glucose monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean absolute relative difference (MARD)
Mean absolute relative difference (MARD) between Dexcom G6 glucoses and point of care blood or plasma glucoses.
Measured: Through study completion, about 2 years
Secondary outcomes (1)
Mean absolute difference (MAD)
MAD between Dexcom G6 glucoses and the point of care blood or plasma glucoses and the percentage of Dexcom G6 glucose values within 15 mg/dL, 20 mg/dL and 30 mg/dL of point of care blood or plasma glucose values when they are <100 mg/dL.
Measured: Through study completion, about 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 Jun 2023
- Primary completion22 Sep 2025
- Study completion22 Sep 2025
Why it stopped: Principal investigator is leaving the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperinsulinismStudies of the same condition, open and under way.
- 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- MemorialCare Health System
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Sponsor
- Investigators
- Erin L Okawa, MD, Principal investigator, Memorial Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363929
- Sponsor's protocol ID
- 341-23
- Status last verified
- Sep 2025
- First submitted
- 20 Dec 2023
- Last updated
- 1 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Accuracy of Continuous Glucose Monitors in Neonates With Hyperinsulinism.
- ClinicalTrials.gov ID
- NCT06363929
- Acronym / sponsor ID
- 341-23
- Conditions
- Hyperinsulinism, Hypoglycemia Neonatal
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal investigator is leaving the study.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- MemorialCare Health SystemUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 22 Sep 2025 (actual)
- Study completion
- 22 Sep 2025 (actual)
- First posted
- 12 Apr 2024 (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 investigators are studying the accuracy of Dexcom G6 continuous glucose monitors placed on babies with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit. The participants will wear the device for 10 days on their lateral thigh. Whenever blood sugars are checked by glucometer, the investigators will also record the continuous glucose monitor sugar. Additionally, if the continuous glucose monitor alarms for a low sugar or an impending low sugar, the investigators will check the blood sugar by glucometer and, if verified to be low, treat the low blood sugar accordingly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates with hyperinsulinism | – | Device: Dexcom G6 continuous glucose monitorNeonates with a diagnosis of hyperinsulinism will wear a Dexcom G6 continuous glucose monitor placed for 10 days. |
Who may qualify
- Ages
- 24 hours to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Neonates with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit
Key inclusion criteria (3 listed)
- Age: 0-90 days old
- Gestational Age: > 28 weeks gestational age
- Diagnosis of hyperinsulinism based on critical sample and/or glucagon challenge
Key exclusion criteria (7 listed)
- Diffuse skin disease such that placement of a Dexcom G6 sensor would be difficult to secure
- Infants colonized or infected with multi-drug resistant organisms (i.e. MRSA, VRE, ESBL producing bacteria)
- Infants on hypothermic protocols
- Infants expected to remain in the NICU <24 hours
- Infants enrolled in a competing clinical trial
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 G6 continuous glucose monitorDexcom G6 continuous glucose monitor to be placed on neonates with hyperinsulinism for 10 days. | Device | Neonates with hyperinsulinism |
Primary outcome
Mean absolute relative difference (MARD)
Time frame: Through study completion, about 2 years
Mean absolute relative difference (MARD) between Dexcom G6 glucoses and point of care blood or plasma glucoses.
1 secondary outcome
Mean absolute difference (MAD)
Time frame: Through study completion, about 2 years
Results and safety
The study was stopped early (reason given: Principal investigator is leaving the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
Related trials for Hyperinsulinism
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
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.
Erin L Okawa, MD principal investigator
Memorial Health Services
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 Hyperinsulinism and Hypoglycemia Neonatal, run by MemorialCare Health System 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 7 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: stopped early, as of the sponsor's last update on 1 Oct 2025. 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?
The study was stopped early (reason given: Principal investigator is leaving the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean absolute relative difference (MARD) (time frame: Through study completion, about 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2025.