Hypoglycemia Clinical Trial
Official title:
Efficacy of Continuous Glucose Monitoring in Neonates With Hypoglycemia
Verified date | October 2021 |
Source | Boston Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 6 |
Est. completion date | August 30, 2018 |
Est. primary completion date | August 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 60 Days |
Eligibility | Inclusion criteria: - 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) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital |
United States,
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. — View Citation
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. Epub 2012 Sep 7. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Up to 28 days | |
Primary | Frequency of Severe Hypoglycemia Events | Severe hypoglycemia is defined as glucose level < 40 mg/dL | 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. | 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. | Up to 28 days | |
Secondary | Time to Stable Euglycemia | Up to 28 days |
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