Neonatal HypoglycemiaNCT04386005
Continuous Glucose Monitoring in At-Risk Newborns
A study testing Continuous Glucose Monitoring Device in people with Neonatal Hypoglycemia, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
Hypoglycemia (low blood glucose) is a very common problem in newborns, and has been associated with poor neurodevelopment, cognition, and school performance. At-risk newborns (infants of diabetic mothers [IDM], large [LGA] and small [SGA] for gestational age infants, and late preterm [LPT] infants) undergo a… Read more about this study
- Who is it for?
- Ages 1 minute to 2 weeks
- Conditions the study is for
- Neonatal Hypoglycemia
- What is being tested?
- Continuous Glucose Monitoring Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2021to 30 Jun 2026
- Phase
- Interventional
- 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 minute to 2 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- At-risk newborns (<48 hours old, all sexes) admitted to the Newborn Nursery or the NICU who meet any of the below criteria:
- Infant of a diabetic mother (IDM, pre-existing or gestational diabetes)
- Large for gestational age (LGA, >90th percentile [sex-specific])
- Small for gestational age (SGA, <10th percentile [sex-specific])
- Late preterm (LPT, 34 0/7 to 36 6/7 weeks' gestation)
- Any newborn undergoing routine blood glucose screening in the newborn nursery per the Neonatal Hypoglycemia protocol (includes newborns of mothers taking oral hypoglycemic agents, beta-blocker medications, or systemic steroids within 7 days before delivery; and newborns with clinical manifestations of hypoglycemia)
Who cannot join
- Birth weight <2kg
- hypoxic-ischemic encephalopathy
- a contraindication to oral feeding
- abnormal skin that will preclude placement of the CGM (e.g., skin on the thigh that is not intact)
- chromosomal abnormalities or severe congenital anomalies identified ante- or postnatally
- infants who are not expected to survive or who are in extremis
Show all 12Show fewer
- additional risk of immunocompromise, including:
- Skin infections, such as staphylococcus or streptococcus skin infections and herpes (skin, eye, and mouth disease) infection
- Skin diseases that add additional risk, such as epidermolysis bullosa, ichthyosis, peeling skin syndrome, and hemangiomas
- Systemic sepsis, viral syndromes
- Immune diseases such as severe combined immunodeficiency, cancer, T-cell or B-cell deficiencies, inborn errors of metabolism, chromosomal abnormalities, glycogen storage diseases, genetic diseases
- Abdominal wall defects
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Health Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Continuous Glucose Monitoring in At-Risk Newborns: A Feasibility Study
Hypoglycemia (low blood glucose) is a very common problem in newborns, and has been associated with poor neurodevelopment, cognition, and school performance. At-risk newborns (infants of diabetic mothers [IDM], large [LGA] and small [SGA] for gestational age infants, and late preterm [LPT] infants) undergo a hypoglycemia screening protocol that involves numerous intermittent needle sticks to test glucose levels on bedside glucometers; however, continuous glucose monitoring (CGM, currently not approved for clinical use in babies), via a small sensor placed in the thigh (only 1 needle stick), would likely decrease pain while providing continuous glucose levels. This study will evaluate the feasibility, safety, and precision of CGM in at-risk newborns, and determine if this method would decrease the amount of painful procedures and episodes of hypoglycemia missed by intermittent sampling.
As part of regular medical care, participants will undergo intermittent blood glucose screening with heel sticks as per the current hospital standard of care protocol. Regular medical care involves checking the participant's blood glucose via heel stick every few hours using a bedside glucometer, with another heel stick to confirm low values in the laboratory. If the participant has low values, he/she may be treated with oral glucose gel, feedings of breast milk or formula, or intravenous (IV) fluids in the Neonatal Intensive Care Unit (NICU). This research study involves placing a CGM device in addition to undergoing the current blood glucose screening protocol and treatment.
Read more
As soon as possible after birth, a continuous glucose monitoring device (Dexcom G7) will be placed on the participant's thigh by a research team member, and will blindly continuously record glucose levels that will be analyzed after discharge. Everyone who agrees to participate in this study will have placement of this experimental device.
The investigational device will stay in place for the same amount of time that a participant is undergoing blood glucose monitoring as per the current standard of care protocol, for a maximum of 7 days. A participant may need to have his/her blood glucose checked after 7 days for regular medical care (and not for research), because his/her glucose concentrations are still low. Being in the research study will not affect a participant's medical care, and will not affect how long he/she needs blood glucose monitoring or treatment.
A research team member will place and remove the CGM. Nurses will evaluate the site of the device for signs of irritation, infection, bleeding, and any other issues at least 3 times per day. After discharge from the hospital, data will be collected from the participant's medical record and participant's mother's medical record, including the participant's sex and birth weight, blood glucose values, details of feedings, treatments given for low glucose concentrations, and NICU admission data. Data that will be collected from the participant's mother's medical record includes age and race, prenatal data, medical history, and medication use. The participant's parents will be asked to fill out a short survey about their experience with this device when it is removed.
- Conditions
- Neonatal Hypoglycemia
- Being tested
- Continuous Glucose Monitoring Device
- Keywords
- blood glucose, continuous glucose monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitoring DeviceDevice
Also called Dexcom G7
The Dexcom G7 Glucose Monitoring System (San Diego, CA) reports continuous interstitial blood glucose concentrations every 5 minutes, does not require calibration, and involves only 1 needle stick to place the sensor. The manufacturer recommends that a single sensor may be used for up to 10 days. The Dexcom G7 system is the only FDA approved CGM system for children (age >2 years).
| Study group | Role | What they receive |
|---|---|---|
| Continuous Glucose Monitoring | Experimental | All participants will have the continuous glucose monitoring device placed. Receives: Device: Continuous Glucose Monitoring Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement of blood glucose concentrations from CGM vs intermittent monitoring
Bland-Altman analysis to evaluate bias and the agreement interval between CGM and intermittent testing
Measured: 1-7 days
Likert-scale questionnaire results from parents, nurses, and research team
Feasibility of the CGM device will be evaluated by administering Likert-scale questionnaire results from parents, nurses, and research team. Questionnaires will assess acceptability of using the device by parents, nurses, and researchers; and ease of use, placement, and maintenance of the device.
Measured: 7 days
Difference in number of needle sticks with CGM vs intermittent glucose monitoring
The total number of estimated needle sticks with GCM will be compared to the total number of needle sticks from intermittent monitoring, using t-test.
Measured: 1-7 days
Difference in number of episodes of hypoglycemia diagnosed with CGM vs intermittent glucose monitoring
Total number of hypoglycemic episodes (blood glucose concentration <40 mg/dL at <4 hours, and <45 mg/dL thereafter) from GCM (episodes lasting >10 minutes) will be compared to the total number of hypoglycemic episodes from intermittent monitoring using t-test. Area under curve analysis will be completed to evaluate duration and severity of hypoglycemic episodes from CGM vs intermittent monitoring, as well as the response to treatment (feedings, dextrose gel, IV dextrose boluses, and dextrose infusions) and timing to normalization of glucose concentrations.
Measured: 1-7 days
Secondary outcomes (1)
Number of participants with adverse outcomes at the device site
Safety of CGM device will be evaluated by examinations for the presence of irritation, infection, cellulitis, bleeding, or other concerns at the device site.
Measured: 3 times per day for 1-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start9 Aug 2021
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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 Milton S. Hershey Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will have the continuous glucose monitoring device placed.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc., Children's Miracle Network
- Responsible party
- Principal investigator, Natalie Allen, Milton S. Hershey Medical Center
- Investigators
- Jeffrey R. Kaiser, MD, MA, Principal investigator, Penn State Health Milton S Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386005
- Sponsor's protocol ID
- 00014068
- Status last verified
- Jul 2026
- First submitted
- 9 May 2020
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Nothing will be shared
Publications
Hay WW Jr, Raju TN, Higgins RD, Kalhan SC, Devaskar SU. Knowledge gaps and research needs for understanding and treating neonatal hypoglycemia: workshop report from Eunice Kennedy Shriver National Institute of Child Health and Human Development. J Pediatr. 2009 Nov;155(5):612-7. doi: 10.1016/j.jpeds.2009.06.044. No abstract available.
PubMed 19840614Kaiser JR, Bai S, Gibson N, Holland G, Lin TM, Swearingen CJ, Mehl JK, ElHassan NO. Association Between Transient Newborn Hypoglycemia and Fourth-Grade Achievement Test Proficiency: A Population-Based Study. JAMA Pediatr. 2015 Oct;169(10):913-21. doi: 10.1001/jamapediatrics.2015.1631.
PubMed 26301959Harris DL, Weston PJ, Harding JE. Incidence of neonatal hypoglycemia in babies identified as at risk. J Pediatr. 2012 Nov;161(5):787-91. doi: 10.1016/j.jpeds.2012.05.022. Epub 2012 Jun 23.
PubMed 22727868Committee on Fetus and Newborn; Adamkin DH. Postnatal glucose homeostasis in late-preterm and term infants. Pediatrics. 2011 Mar;127(3):575-9. doi: 10.1542/peds.2010-3851. Epub 2011 Feb 28.
PubMed 21357346Galderisi A, Facchinetti A, Steil GM, Ortiz-Rubio P, Cavallin F, Tamborlane WV, Baraldi E, Cobelli C, Trevisanuto D. Continuous Glucose Monitoring in Very Preterm Infants: A Randomized Controlled Trial. Pediatrics. 2017 Oct;140(4):e20171162. doi: 10.1542/peds.2017-1162. Epub 2017 Sep 15.
PubMed 28916591Agus MSD, Wypij D, Nadkarni, VM. Tight Glycemic Control in Critically Ill Children. N Engl J Med. 2017 Jun 8;376(23):e48. doi: 10.1056/NEJMc1703642. No abstract available.
PubMed 28591530Beardsall K, Vanhaesebrouck S, Ogilvy-Stuart AL, Vanhole C, Palmer CR, van Weissenbruch M, Midgley P, Thompson M, Thio M, Cornette L, Ossuetta I, Iglesias I, Theyskens C, de Jong M, Ahluwalia JS, de Zegher F, Dunger DB. Early insulin therapy in very-low-birth-weight infants. N Engl J Med. 2008 Oct 30;359(18):1873-84. doi: 10.1056/NEJMoa0803725.
PubMed 18971490Shah R, McKinlay CJD, Harding JE. Neonatal hypoglycemia: continuous glucose monitoring. Curr Opin Pediatr. 2018 Apr;30(2):204-208. doi: 10.1097/MOP.0000000000000592.
PubMed 29346140Stechova K, Cerny M, Brabec R, Ulmannova T, Bartaskova D, Spalova I, Zoban P. Experience with real time continuous glucose monitoring in stabilising fluctuating glycaemia during intensive care of the preterm infant of a diabetic mother. J Matern Fetal Neonatal Med. 2014 Sep;27(13):1389-91. doi: 10.3109/14767058.2013.858686. Epub 2013 Nov 13.
PubMed 24156750Uettwiller F, Chemin A, Bonnemaison E, Favrais G, Saliba E, Labarthe F. Real-time continuous glucose monitoring reduces the duration of hypoglycemia episodes: a randomized trial in very low birth weight neonates. PLoS One. 2015 Jan 15;10(1):e0116255. doi: 10.1371/journal.pone.0116255. eCollection 2015.
PubMed 25590334Wackernagel D, Dube M, Blennow M, Tindberg Y. Continuous subcutaneous glucose monitoring is accurate in term and near-term infants at risk of hypoglycaemia. Acta Paediatr. 2016 Aug;105(8):917-23. doi: 10.1111/apa.13479. Epub 2016 Jun 8.
PubMed 27203555Harris DL, Battin MR, Weston PJ, Harding JE. Continuous glucose monitoring in newborn babies at risk of hypoglycemia. J Pediatr. 2010 Aug;157(2):198-202.e1. doi: 10.1016/j.jpeds.2010.02.003. Epub 2010 Mar 24.
PubMed 20338573Anand KJ, Coskun V, Thrivikraman KV, Nemeroff CB, Plotsky PM. Long-term behavioral effects of repetitive pain in neonatal rat pups. Physiol Behav. 1999 Jun;66(4):627-37. doi: 10.1016/s0031-9384(98)00338-2.
PubMed 10386907Patel NS, Duke RP, Tian Z, Zhou S, Kaiser JR. Agreement between intermittent glucose concentrations and continuous glucose monitoring in at-risk newborns. J Perinatol. 2024 Sep;44(9):1367-1368. doi: 10.1038/s41372-024-01906-6. Epub 2024 Feb 19. No abstract available.
PubMed 38374217
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring in At-Risk Newborns: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04386005
- Acronym / sponsor ID
- 00014068
- Conditions
- Neonatal Hypoglycemia
- Keywords
- blood glucose, continuous glucose monitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- DexCom, Inc., Children's Miracle Network
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 13 May 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.
Hypoglycemia (low blood glucose) is a very common problem in newborns, and has been associated with poor neurodevelopment, cognition, and school performance. At-risk newborns (infants of diabetic mothers [IDM], large [LGA] and small [SGA] for gestational age infants, and late preterm [LPT] infants) undergo a hypoglycemia screening protocol that involves numerous intermittent needle sticks to test glucose levels on bedside glucometers; however, continuous glucose monitoring (CGM, currently not approved for clinical use in babies), via a small sensor placed in the thigh (only 1 needle stick), would likely decrease pain while providing continuous glucose levels. This study will evaluate the feasibility, safety, and precision of CGM in at-risk newborns, and determine if this method would decrease the amount of painful procedures and episodes of hypoglycemia missed by intermittent sampling.
As part of regular medical care, participants will undergo intermittent blood glucose screening with heel sticks as per the current hospital standard of care protocol. Regular medical care involves checking the participant's blood glucose via heel stick every few hours using a bedside glucometer, with another heel stick to confirm low values in the laboratory. If the participant has low values, he/she may be treated with oral glucose gel, feedings of breast milk or formula, or intravenous (IV) fluids in the Neonatal Intensive Care Unit (NICU). This research study involves placing a CGM device in addition to undergoing the current blood glucose screening protocol and treatment.
As soon as possible after birth, a continuous glucose monitoring device (Dexcom G7) will be placed on the participant's thigh by a research team member, and will blindly continuously record glucose levels that will be analyzed after discharge. Everyone who agrees to participate in this study will have placement of this experimental device.
The investigational device will stay in place for the same amount of time that a participant is undergoing blood glucose monitoring as per the current standard of care protocol, for a maximum of 7 days. A participant may need to have his/her blood glucose checked after 7 days for regular medical care (and not for research), because his/her glucose concentrations are still low. Being in the research study will not affect a participant's medical care, and will not affect how long he/she needs blood glucose monitoring or treatment.
A research team member will place and remove the CGM. Nurses will evaluate the site of the device for signs of irritation, infection, bleeding, and any other issues at least 3 times per day. After discharge from the hospital, data will be collected from the participant's medical record and participant's mother's medical record, including the participant's sex and birth weight, blood glucose values, details of feedings, treatments given for low glucose concentrations, and NICU admission data. Data that will be collected from the participant's mother's medical record includes age and race, prenatal data, medical history, and medication use. The participant's parents will be asked to fill out a short survey about their experience with this device when it is removed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will have the continuous glucose monitoring device placed.
| Arm | Type | Receives |
|---|---|---|
| Continuous Glucose Monitoring | Experimental | Device: Continuous Glucose Monitoring DeviceAll participants will have the continuous glucose monitoring device placed. |
Who may qualify
- Ages
- 1 minute to 2 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- At-risk newborns (<48 hours old, all sexes) admitted to the Newborn Nursery or the NICU who meet any of the below criteria:
- Any newborn undergoing routine blood glucose screening in the newborn nursery per the Neonatal Hypoglycemia protocol (includes newborns of mothers taking oral hypoglycemic agents, beta-blocker medications, or systemic steroids within 7 days before delivery; and newborns with clinical manifestations of hypoglycemia)
Key exclusion criteria (12 listed)
- Birth weight <2kg
- hypoxic-ischemic encephalopathy
- a contraindication to oral feeding
- abnormal skin that will preclude placement of the CGM (e.g., skin on the thigh that is not intact)
- chromosomal abnormalities or severe congenital anomalies identified ante- or postnatally
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 |
|---|---|---|
| Continuous Glucose Monitoring DeviceAlso: Dexcom G7The Dexcom G7 Glucose Monitoring System (San Diego, CA) reports continuous interstitial blood glucose concentrations every 5 minutes, does not require calibration, and involves only 1 needle stick to place the sensor. The manufacturer recommends that a single sensor may be used for up to 10 days. The Dexcom G7 system is the only FDA approved CGM system for children (age >2 years). | Device | Continuous Glucose Monitoring |
Primary outcome
Agreement of blood glucose concentrations from CGM vs intermittent monitoring
Time frame: 1-7 days
Bland-Altman analysis to evaluate bias and the agreement interval between CGM and intermittent testing
Likert-scale questionnaire results from parents, nurses, and research team
Time frame: 7 days
Feasibility of the CGM device will be evaluated by administering Likert-scale questionnaire results from parents, nurses, and research team. Questionnaires will assess acceptability of using the device by parents, nurses, and researchers; and ease of use, placement, and maintenance of the device.
Difference in number of needle sticks with CGM vs intermittent glucose monitoring
Time frame: 1-7 days
The total number of estimated needle sticks with GCM will be compared to the total number of needle sticks from intermittent monitoring, using t-test.
Difference in number of episodes of hypoglycemia diagnosed with CGM vs intermittent glucose monitoring
Time frame: 1-7 days
Total number of hypoglycemic episodes (blood glucose concentration <40 mg/dL at <4 hours, and <45 mg/dL thereafter) from GCM (episodes lasting >10 minutes) will be compared to the total number of hypoglycemic episodes from intermittent monitoring using t-test. Area under curve analysis will be completed to evaluate duration and severity of hypoglycemic episodes from CGM vs intermittent monitoring, as well as the response to treatment (feedings, dextrose gel, IV dextrose boluses, and dextrose infusions) and timing to normalization of glucose concentrations.
1 secondary outcome
Number of participants with adverse outcomes at the device site
Time frame: 3 times per day for 1-7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Background: PubMed 19840614Hay WW Jr, Raju TN, Higgins RD, Kalhan SC, Devaskar SU. Knowledge gaps and research needs for understanding and treating neonatal hypoglycemia: workshop report from Eunice Kennedy Shriver National Institute of Child Health and Human Development. J Pediatr. 2009 Nov;155(5):612-7. doi: 10.1016/j.jpeds.2009.06.044. No abstract available.
- Background: PubMed 26301959Kaiser JR, Bai S, Gibson N, Holland G, Lin TM, Swearingen CJ, Mehl JK, ElHassan NO. Association Between Transient Newborn Hypoglycemia and Fourth-Grade Achievement Test Proficiency: A Population-Based Study. JAMA Pediatr. 2015 Oct;169(10):913-21. doi: 10.1001/jamapediatrics.2015.1631.
- Background: PubMed 22727868Harris DL, Weston PJ, Harding JE. Incidence of neonatal hypoglycemia in babies identified as at risk. J Pediatr. 2012 Nov;161(5):787-91. doi: 10.1016/j.jpeds.2012.05.022. Epub 2012 Jun 23.
- Background: PubMed 21357346Committee on Fetus and Newborn; Adamkin DH. Postnatal glucose homeostasis in late-preterm and term infants. Pediatrics. 2011 Mar;127(3):575-9. doi: 10.1542/peds.2010-3851. Epub 2011 Feb 28.
- Background: PubMed 28916591Galderisi A, Facchinetti A, Steil GM, Ortiz-Rubio P, Cavallin F, Tamborlane WV, Baraldi E, Cobelli C, Trevisanuto D. Continuous Glucose Monitoring in Very Preterm Infants: A Randomized Controlled Trial. Pediatrics. 2017 Oct;140(4):e20171162. doi: 10.1542/peds.2017-1162. Epub 2017 Sep 15.
- Background: PubMed 28591530Agus MSD, Wypij D, Nadkarni, VM. Tight Glycemic Control in Critically Ill Children. N Engl J Med. 2017 Jun 8;376(23):e48. doi: 10.1056/NEJMc1703642. No abstract available.
- Background: PubMed 18971490Beardsall K, Vanhaesebrouck S, Ogilvy-Stuart AL, Vanhole C, Palmer CR, van Weissenbruch M, Midgley P, Thompson M, Thio M, Cornette L, Ossuetta I, Iglesias I, Theyskens C, de Jong M, Ahluwalia JS, de Zegher F, Dunger DB. Early insulin therapy in very-low-birth-weight infants. N Engl J Med. 2008 Oct 30;359(18):1873-84. doi: 10.1056/NEJMoa0803725.
- Background: PubMed 29346140Shah R, McKinlay CJD, Harding JE. Neonatal hypoglycemia: continuous glucose monitoring. Curr Opin Pediatr. 2018 Apr;30(2):204-208. doi: 10.1097/MOP.0000000000000592.
- Background: PubMed 24156750Stechova K, Cerny M, Brabec R, Ulmannova T, Bartaskova D, Spalova I, Zoban P. Experience with real time continuous glucose monitoring in stabilising fluctuating glycaemia during intensive care of the preterm infant of a diabetic mother. J Matern Fetal Neonatal Med. 2014 Sep;27(13):1389-91. doi: 10.3109/14767058.2013.858686. Epub 2013 Nov 13.
- Background: PubMed 25590334Uettwiller F, Chemin A, Bonnemaison E, Favrais G, Saliba E, Labarthe F. Real-time continuous glucose monitoring reduces the duration of hypoglycemia episodes: a randomized trial in very low birth weight neonates. PLoS One. 2015 Jan 15;10(1):e0116255. doi: 10.1371/journal.pone.0116255. eCollection 2015.
- Background: PubMed 27203555Wackernagel D, Dube M, Blennow M, Tindberg Y. Continuous subcutaneous glucose monitoring is accurate in term and near-term infants at risk of hypoglycaemia. Acta Paediatr. 2016 Aug;105(8):917-23. doi: 10.1111/apa.13479. Epub 2016 Jun 8.
- Background: PubMed 20338573Harris DL, Battin MR, Weston PJ, Harding JE. Continuous glucose monitoring in newborn babies at risk of hypoglycemia. J Pediatr. 2010 Aug;157(2):198-202.e1. doi: 10.1016/j.jpeds.2010.02.003. Epub 2010 Mar 24.
- Individual participant dataSharing planned: No. Nothing will be shared
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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.
Jeffrey R. Kaiser, MD, MA principal investigator
Penn State Health Milton S Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitoring Device in people with Neonatal Hypoglycemia, run by Milton S. Hershey Medical Center 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 29 Jul 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Agreement of blood glucose concentrations from CGM vs intermittent monitoring (time frame: 1-7 days). The study lists 4 primary outcomes in all. 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 NCT04386005, which also lists 14 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 29 Jul 2026.