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Insufficient eligible participants to meet recruitment goal
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM Protocol | Experimental | Subjects will receive continuous glucose monitoring and caregivers will be able to view continuous glucose measurements. |
|
| Standard of Care | Placebo Comparator | Subjects will receive continuous glucose monitoring but caregivers will not be able to view continuous glucose measurements. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitoring | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 28 days |
| Frequency of Severe Hypoglycemia Events | Severe hypoglycemia is defined as glucose level < 40 mg/dL | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up tp 28 days |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Agus, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21499183 | Background | 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. | |
| 22957521 | Background | Agus 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CGM Protocol | Subjects will receive continuous glucose monitoring and caregivers will be able to view continuous glucose measurements. Continuous Glucose Monitoring: 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. |
| FG001 | Standard of Care | Subjects will receive continuous glucose monitoring but caregivers will not be able to view continuous glucose measurements. Continuous Glucose Monitoring: 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 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CGM Protocol | Subjects will receive continuous glucose monitoring and caregivers will be able to view continuous glucose measurements. Continuous Glucose Monitoring: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Events | Up to 28 days |
|
Up to 28 days from enrollment and insertion of initial continuous glucose glucose monitor sensor.
This is a Non-Significant-Risk (NSR) device study. If it is determined that an unanticipated adverse device effect presents an unreasonable risk to subjects, all investigations or parts of the investigations presenting that risk will be terminated as soon as possible and no later than 5 working days after the sponsor makes this determination. Because this is a small pilot study with minimal risk, no specific stopping rules will be developed and no interim analysis will be performed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CGM Protocol | Subjects will receive continuous glucose monitoring and caregivers will be able to view continuous glucose measurements. Continuous Glucose Monitoring: 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. |
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The trial terminated due to lack of enrollment, thus limited data are available.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael SD Agus, MD | Boston Children's Hospital | 617 355-5849 | michael.agus@childrens.harvard..edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2017 | Dec 22, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
|
| 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. | Up to 28 days |
| Time to Stable Euglycemia | Up to 28 days |
| 24671945 | Background | Agus 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. |
| BG001 | Standard of Care | Subjects will receive continuous glucose monitoring but caregivers will not be able to view continuous glucose measurements. Continuous Glucose Monitoring: 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 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. |
| BG002 | Total | Total of all reporting groups |
| Days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Standard of Care | Subjects will receive continuous glucose monitoring but caregivers will not be able to view continuous glucose measurements. Continuous Glucose Monitoring: 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 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. |
|
|
| Primary | Frequency of Severe Hypoglycemia Events | Severe hypoglycemia is defined as glucose level < 40 mg/dL | Posted | Number | Events | Up to 28 days |
|
|
|
| Secondary | 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. | Events of diagnosis of hyperinsulinemic hypoglycemia | Posted | Number | Events | up tp 28 days |
|
|
|
| Secondary | 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. | Posted | Mean | Full Range | Days | Up to 28 days |
|
|
|
| Secondary | Time to Stable Euglycemia | Patients did not remain on protocol until euglycemia was reached, therefore no data was collected for this Outcome Measure. | Posted | Up to 28 days |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Standard of Care | Subjects will receive continuous glucose monitoring but caregivers will not be able to view continuous glucose measurements. Continuous Glucose Monitoring: 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 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. | 0 | 3 | 0 | 3 | 0 | 3 |
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| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |