HypoglycemiaNCT02300285
Efficacy of Continuous Glucose Monitoring in Neonates With Hypoglycemia
A study testing Continuous Glucose Monitoring in people with Hypoglycemia and Newborn Morbidity, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Our aim is to determine the feasibility of using continuous glucose monitors (CGMs) in infants with low blood glucose to improve how we care for these infants. To do this we plan on monitoring blood glucose levels with CGMs (instead of only with intermittent bloodsampling) in late-preterm and term infants admitted to… Read more about this study
- Who is it for?
- Ages Up to 60 days
- Conditions the study is for
- Hypoglycemia, Newborn Morbidity
- What is being tested?
- Continuous Glucose Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 30 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 60 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 0-60 days old
- Late-preterm and term infants (babies born more than 33 weeks and 6 days after the start of the pregnancy)
- History of low blood sugars (hypoglycemia): two episodes of hypoglycemia more than 1 hour apart (low blood sugar will be defined by age: for those less than 48 hours old a low blood sugar is considered less than 50mg/dL and for those older than 48 hours old less than 70mg/dL)
Who cannot join
- Infants with skin disease such that placement of a glucose sensor under the skin would be difficult to secure
- Infants expected to remain in NICU less than 24 hours
- Infants on a hypothermic protocol
- Infants enrolled in a competing clinical trial
- Family/team have decided to limit or redirect from aggressive NICU technological support
- infants who are wards of the state
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Our aim is to determine the feasibility of using continuous glucose monitors (CGMs) in infants with low blood glucose to improve how we care for these infants. To do this we plan on monitoring blood glucose levels with CGMs (instead of only with intermittent bloodsampling) in late-preterm and term infants admitted to the NICU who have had hypoglycemia. To see if using CGMs helps us prevent low blood glucose levels and allows us to find a diagnosis and treat sooner, we will randomize patients into one of two groups: a "CGM group" where the CGM information is made available to the NICU team and a "Standard of Care" group where the CGM information will only be available to the research team. However, if infants in the "Standard of Care" group are noted to have three unrecognized severe low blood glucose levels then the research team will inform the NICU team that this has occurred.
Read the detailed description
We aim to evaluate the utility of continuous glucose monitors (CGMs) in improving the diagnosis and management of neonatal hypoglycemia in infants admitted to the neonatal intensive care unit (NICU). Specifically, we hope to assess whether the use of CGMs in this population reduces the number and severity of hypoglycemic events, reduces the time to diagnosis of the etiology of hypoglycemia and/or reduces the time taken to achieve stable euglycemia on a sustainable feeding regimen. We plan to perform a prospective pilot and feasibility study comparing the clinical course and outcomes of newborns with hypoglycemia admitted to the NICU who are actively monitored with CGMs versus those who receive routine care. Eligible infants will be late preterm and term infants admitted to the Boston Children's Hospital who have had two documented hypoglycemic episodes during their current admission. Families will be approached for consent shortly after diagnosis of recurrent hypoglycemia. As all of these infants will be undergoing periodic blood glucose monitoring as part of their routine care, enrollment in this study will involve minimal additional interventions, including CGM placement, which involves placement of a small subcutaneous needle sensor, and the possibility of drawing additional blood glucose samples if hypoglycemia is detected by CGM. All enrolled infants will be placed on a CGM monitor and then randomized to either the "CGM Protocol" or "Standard of Care" group. Those on the CGM Protocol will have a fully accessible CGM that will be analyzed for blood glucose trends and will alarm for any blood glucose level approaching hypoglycemic threshold (eg. BG <70 mg/dL). Those in the "Standard of Care" group will have a CGM in place, but values will not be available to the clinical team except if severe hypoglycemia is recorded (eg. BG <40 mg/dL). Whenever the CGM alarms or there is a concerning blood glucose trend as measured by the CGM, the nurse will be asked to check a blood glucose value. All clinical management decisions will be made by the clinical team based on confirmed blood glucose values. In the control group, the only change to current management is the potential performance of additional blood glucose checks that may be prompted by CGM alarms for severe hypoglycemia. The CGM will remain in place until the infant is no longer being monitored for glycemic stability or the infant is discharged. We will record all blood glucose levels, laboratory data related to investigation of the underlying cause of hypoglycemia, all intravenous and enteral sources of glucose, and uses of other therapeutic interventions such as diazoxide and carnitine replacement. We will also compare blood glucose data with information from the CGM monitors to assess accuracy. We will then compare severity and frequency of hypoglycemia, as well as times to diagnosis and euglycemia between the "CGM" and "Standard of Care" groups.
- Conditions
- Hypoglycemia, Newborn Morbidity
- Being tested
- Continuous Glucose Monitoring
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose MonitoringDevice
Also called Dexcom G4 Platinum
Continuous glucose monitors (CGM) will be used to monitor blood sugar levels in enrolled subjects. CGMs measure blood sugar in the tissue just under the skin every few seconds and report average blood sugar every 5 minutes. In our study, the CGMs will function as monitoring systems. In the CGM protocol group the CGM will let the medical team know if there is a concerning blood sugar level, so that the medical team can then check a blood sugar level by the standard way (usually in a small drop of blood) and then decide if they need to give any medical treatment. In the Standard of Care group the CGM data will not be visible to the medical team but the medical team will be informed by the researchers if there are multiple unrecognized episodes of severe hypoglycemia.
| Study group | Role | What they receive |
|---|---|---|
| CGM Protocol | Experimental | Subjects will receive continuous glucose monitoring and caregivers will be able to view continuous glucose measurements. Receives: Device: Continuous Glucose Monitoring |
| Standard of Care | Placebo comparator | Subjects will receive continuous glucose monitoring but caregivers will not be able to view continuous glucose measurements. Receives: Device: Continuous Glucose Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Hypoglycemic Events
Hypoglycemia is defined by age group: for patients less than 48 hours of life, hypoglycemia is defined as glucose level < 50 mg/dL for patients greater than or equal to 48 hours of life it is defined as glucose level < 70 mg/dL.
Measured: Up to 28 days
Frequency of Severe Hypoglycemia Events
Severe hypoglycemia is defined as glucose level < 40 mg/dL
Measured: Up to 28 days
Secondary outcomes (3)
Number of Events Where Etiology of Hypoglycemia Was Established
Diagnosis of the etiology of hypoglycemia, and the time to to do, will be evaluated in order to determine if the use of CGM will prompt earlier testing to evaluate the etiology of the hypoglycemia and therefore lead to earlier ascertainment of the underlying etiology. Diagnosis of etiology.
Measured: up tp 28 days
Time to Diagnosis of Etiology of Hypoglycemia
Diagnosis of the etiology of hypoglycemia, and the time to to do, will be evaluated in order to determine if the use of CGM will prompt earlier testing to evaluate the etiology of the hypoglycemia and therefore lead to earlier ascertainment of the underlying etiology. Time to diagnosis of etiology.
Measured: Up to 28 days
Time to Stable Euglycemia
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startFeb 2015
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Why it stopped: Insufficient eligible participants to meet recruitment goal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Agus, Boston Children's Hospital
- Investigators
- Michael Agus, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300285
- Sponsor's protocol ID
- IRB-P00014699
- Status last verified
- Oct 2021
- First submitted
- 20 Nov 2014
- Last updated
- 1 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Steil GM, Langer M, Jaeger K, Alexander J, Gaies M, Agus MS. Value of continuous glucose monitoring for minimizing severe hypoglycemia during tight glycemic control. Pediatr Crit Care Med. 2011 Nov;12(6):643-8. doi: 10.1097/PCC.0b013e31821926a5.
PubMed 21499183Agus MS, Steil GM, Wypij D, Costello JM, Laussen PC, Langer M, Alexander JL, Scoppettuolo LA, Pigula FA, Charpie JR, Ohye RG, Gaies MG; SPECS Study Investigators. Tight glycemic control versus standard care after pediatric cardiac surgery. N Engl J Med. 2012 Sep 27;367(13):1208-19. doi: 10.1056/NEJMoa1206044. Epub 2012 Sep 7.
PubMed 22957521Agus MS, Asaro LA, Steil GM, Alexander JL, Silverman M, Wypij D, Gaies MG; SPECS Investigators. Tight glycemic control after pediatric cardiac surgery in high-risk patient populations: a secondary analysis of the safe pediatric euglycemia after cardiac surgery trial. Circulation. 2014 Jun 3;129(22):2297-304. doi: 10.1161/CIRCULATIONAHA.113.008124. Epub 2014 Mar 26.
PubMed 24671945
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Continuous Glucose Monitoring in Neonates With Hypoglycemia
- ClinicalTrials.gov ID
- NCT02300285
- Acronym / sponsor ID
- IRB-P00014699
- Conditions
- Hypoglycemia, Newborn Morbidity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient eligible participants to meet recruitment goal
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 25 Nov 2014 (estimated)
- Results
- Posted 7 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our aim is to determine the feasibility of using continuous glucose monitors (CGMs) in infants with low blood glucose to improve how we care for these infants. To do this we plan on monitoring blood glucose levels with CGMs (instead of only with intermittent bloodsampling) in late-preterm and term infants admitted to the NICU who have had hypoglycemia. To see if using CGMs helps us prevent low blood glucose levels and allows us to find a diagnosis and treat sooner, we will randomize patients into one of two groups: a "CGM group" where the CGM information is made available to the NICU team and a "Standard of Care" group where the CGM information will only be available to the research team. However, if infants in the "Standard of Care" group are noted to have three unrecognized severe low blood glucose levels then the research team will inform the NICU team that this has occurred.
Detailed description
We aim to evaluate the utility of continuous glucose monitors (CGMs) in improving the diagnosis and management of neonatal hypoglycemia in infants admitted to the neonatal intensive care unit (NICU). Specifically, we hope to assess whether the use of CGMs in this population reduces the number and severity of hypoglycemic events, reduces the time to diagnosis of the etiology of hypoglycemia and/or reduces the time taken to achieve stable euglycemia on a sustainable feeding regimen. We plan to perform a prospective pilot and feasibility study comparing the clinical course and outcomes of newborns with hypoglycemia admitted to the NICU who are actively monitored with CGMs versus those who receive routine care. Eligible infants will be late preterm and term infants admitted to the Boston Children's Hospital who have had two documented hypoglycemic episodes during their current admission. Families will be approached for consent shortly after diagnosis of recurrent hypoglycemia. As all of these infants will be undergoing periodic blood glucose monitoring as part of their routine care, enrollment in this study will involve minimal additional interventions, including CGM placement, which involves placement of a small subcutaneous needle sensor, and the possibility of drawing additional blood glucose samples if hypoglycemia is detected by CGM. All enrolled infants will be placed on a CGM monitor and then randomized to either the "CGM Protocol" or "Standard of Care" group. Those on the CGM Protocol will have a fully accessible CGM that will be analyzed for blood glucose trends and will alarm for any blood glucose level approaching hypoglycemic threshold (eg. BG <70 mg/dL). Those in the "Standard of Care" group will have a CGM in place, but values will not be available to the clinical team except if severe hypoglycemia is recorded (eg. BG <40 mg/dL). Whenever the CGM alarms or there is a concerning blood glucose trend as measured by the CGM, the nurse will be asked to check a blood glucose value. All clinical management decisions will be made by the clinical team based on confirmed blood glucose values. In the control group, the only change to current management is the potential performance of additional blood glucose checks that may be prompted by CGM alarms for severe hypoglycemia. The CGM will remain in place until the infant is no longer being monitored for glycemic stability or the infant is discharged. We will record all blood glucose levels, laboratory data related to investigation of the underlying cause of hypoglycemia, all intravenous and enteral sources of glucose, and uses of other therapeutic interventions such as diazoxide and carnitine replacement. We will also compare blood glucose data with information from the CGM monitors to assess accuracy. We will then compare severity and frequency of hypoglycemia, as well as times to diagnosis and euglycemia between the "CGM" and "Standard of Care" groups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGM Protocol | Experimental | Device: Continuous Glucose MonitoringSubjects will receive continuous glucose monitoring and caregivers will be able to view continuous glucose measurements. |
| Standard of Care | Placebo comparator | Device: Continuous Glucose MonitoringSubjects will receive continuous glucose monitoring but caregivers will not be able to view continuous glucose measurements. |
Who may qualify
- Ages
- Up to 60 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 0-60 days old
- Late-preterm and term infants (babies born more than 33 weeks and 6 days after the start of the pregnancy)
- History of low blood sugars (hypoglycemia): two episodes of hypoglycemia more than 1 hour apart (low blood sugar will be defined by age: for those less than 48 hours old a low blood sugar is considered less than 50mg/dL and for those older than 48 hours old less than 70mg/dL)
Key exclusion criteria (6 listed)
- Infants with skin disease such that placement of a glucose sensor under the skin would be difficult to secure
- Infants expected to remain in NICU less than 24 hours
- Infants on a hypothermic protocol
- Infants enrolled in a competing clinical trial
- Family/team have decided to limit or redirect from aggressive NICU technological support
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 MonitoringAlso: Dexcom G4 PlatinumContinuous glucose monitors (CGM) will be used to monitor blood sugar levels in enrolled subjects. CGMs measure blood sugar in the tissue just under the skin every few seconds and report average blood sugar every 5 minutes. In our study, the CGMs will function as monitoring systems. In the CGM protocol group the CGM will let the medical team know if there is a concerning blood sugar level, so that the medical team can then check a blood sugar level by the standard way (usually in a small drop of blood) and then decide if they need to give any medical treatment. In the Standard of Care group the CGM data will not be visible to the medical team but the medical team will be informed by the researchers if there are multiple unrecognized episodes of severe hypoglycemia. | Device | CGM Protocol, Standard of Care |
Primary outcome
Frequency of Hypoglycemic Events
Time frame: Up to 28 days
Hypoglycemia is defined by age group: for patients less than 48 hours of life, hypoglycemia is defined as glucose level < 50 mg/dL for patients greater than or equal to 48 hours of life it is defined as glucose level < 70 mg/dL.
Frequency of Severe Hypoglycemia Events
Time frame: Up to 28 days
Severe hypoglycemia is defined as glucose level < 40 mg/dL
3 secondary outcomes
Number of Events Where Etiology of Hypoglycemia Was Established
Time frame: up tp 28 days
Time to Diagnosis of Etiology of Hypoglycemia
Time frame: Up to 28 days
Time to Stable Euglycemia
Time frame: Up to 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21499183Steil GM, Langer M, Jaeger K, Alexander J, Gaies M, Agus MS. Value of continuous glucose monitoring for minimizing severe hypoglycemia during tight glycemic control. Pediatr Crit Care Med. 2011 Nov;12(6):643-8. doi: 10.1097/PCC.0b013e31821926a5.
- Background: PubMed 22957521Agus MS, Steil GM, Wypij D, Costello JM, Laussen PC, Langer M, Alexander JL, Scoppettuolo LA, Pigula FA, Charpie JR, Ohye RG, Gaies MG; SPECS Study Investigators. Tight glycemic control versus standard care after pediatric cardiac surgery. N Engl J Med. 2012 Sep 27;367(13):1208-19. doi: 10.1056/NEJMoa1206044. Epub 2012 Sep 7.
- Background: PubMed 24671945Agus MS, Asaro LA, Steil GM, Alexander JL, Silverman M, Wypij D, Gaies MG; SPECS Investigators. Tight glycemic control after pediatric cardiac surgery in high-risk patient populations: a secondary analysis of the safe pediatric euglycemia after cardiac surgery trial. Circulation. 2014 Jun 3;129(22):2297-304. doi: 10.1161/CIRCULATIONAHA.113.008124. Epub 2014 Mar 26.
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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.
Michael Agus, MD principal investigator
Boston Children's Hospital
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 in people with Hypoglycemia and Newborn Morbidity, run by Boston Children's Hospital 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: stopped early, as of the sponsor's last update on 1 Nov 2021. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 7 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Frequency of Hypoglycemic Events (time frame: Up to 28 days). The study lists 2 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 NCT02300285, 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 1 Nov 2021.