Trial Outcomes & Findings for Efficacy of Continuous Glucose Monitoring in Neonates With Hypoglycemia (NCT NCT02300285)

NCT ID: NCT02300285

Last Updated: 2021-11-01

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: Up to 28 days
• Results posted on: 2021-11-01

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	3	3
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	CGM Protocol n=3 Participants 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.	Standard of Care n=3 Participants 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.	Total n=6 Participants Total of all reporting groups
Age, Continuous	3.0 Days n=3 Participants	3.33 Days n=3 Participants	3.17 Days n=6 Participants
Sex: Female, Male Female	2 Participants n=3 Participants	2 Participants n=3 Participants	4 Participants n=6 Participants
Sex: Female, Male Male	1 Participants n=3 Participants	1 Participants n=3 Participants	2 Participants n=6 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	3 participants n=3 Participants	3 participants n=3 Participants	6 participants n=6 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	CGM Protocol n=3 Participants 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.	Standard of Care n=3 Participants 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.
Frequency of Hypoglycemic Events	14 Events Standard Deviation 2	19 Events Standard Deviation 3

PRIMARY outcome

Timeframe: Up to 28 days

Severe hypoglycemia is defined as glucose level < 40 mg/dL

Outcome measures

Measure	CGM Protocol n=3 Participants 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.	Standard of Care n=3 Participants 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.
Frequency of Severe Hypoglycemia Events	1 Events	4 Events

SECONDARY outcome

Timeframe: up tp 28 days

Population: Events of diagnosis of hyperinsulinemic 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. Diagnosis of etiology.

Outcome measures

Measure	CGM Protocol n=3 Participants 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.	Standard of Care n=3 Participants 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.
Number of Events Where Etiology of Hypoglycemia Was Established	2 Events	1 Events

SECONDARY outcome

Timeframe: Up to 28 days

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.

Outcome measures

Measure	CGM Protocol n=3 Participants 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.	Standard of Care n=3 Participants 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.
Time to Diagnosis of Etiology of Hypoglycemia	1.5 Days Interval 1.0 to 2.0	4 Days Interval 4.0 to 4.0

SECONDARY outcome

Timeframe: Up to 28 days

Population: Patients did not remain on protocol until euglycemia was reached, therefore no data was collected for this Outcome Measure.

Outcome measures

Outcome data not reported

Adverse Events

CGM Protocol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael SD Agus, MD

Boston Children's Hospital

Phone: 617 355-5849

Email: michael.agus@childrens.harvard..edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place