Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05902104
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2023-05-25
Brief Title:
CGM-Assisted Management of PN
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
CAMP CGM-Assisted Management of PN
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAMP
Brief Summary:
The purpose of this study is to learn more about changes in glucose levels in hospitalized infants with intestinal failure receiving parenteral nutrition or PN nutrients delivered intravenously as they transition from continuous PN given 24 hours a day to cycled PN given less than 24 hours a day
There is an increased risk of glucose abnormalities with cycled PN which can be harmful to infant growth and brain health Continuous glucose monitors CGM will be used to measure interstitial glucose levels in the tissue under the skin which are similar to blood glucose levels CGM is a small minimally-invasive sensor worn on the thigh which gives a glucose measurement every 5 minutes and can help us understand changes in blood sugar levels without having to do a blood draw or fingerstick CGM will be used during PN cycling for up to 30 days or until hospital discharge If target GIR cycled PN is not reached following 3 sensor periods up to 10 days per sensor the parentguardian will be approached to accept or decline participation in an optional extension phase In the extension phase the primary study will be repeated and CGM monitoring will continue until target GIR cycled PN is reached up to an additional 3 sensor placements CGM data will be hidden from the clinical team there will be no change to routine clinical care This study may help us understand how cycled PN affects glucose levels in infants with intestinal failure which may help other children treated with cycled PN in the future
There is an increased risk of glucose abnormalities with cycled PN which can be harmful to infant growth and brain health Continuous glucose monitors CGM will be used to measure interstitial glucose levels in the tissue under the skin which are similar to blood glucose levels CGM is a small minimally-invasive sensor worn on the thigh which gives a glucose measurement every 5 minutes and can help us understand changes in blood sugar levels without having to do a blood draw or fingerstick CGM will be used during PN cycling for up to 30 days or until hospital discharge If target GIR cycled PN is not reached following 3 sensor periods up to 10 days per sensor the parentguardian will be approached to accept or decline participation in an optional extension phase In the extension phase the primary study will be repeated and CGM monitoring will continue until target GIR cycled PN is reached up to an additional 3 sensor placements CGM data will be hidden from the clinical team there will be no change to routine clinical care This study may help us understand how cycled PN affects glucose levels in infants with intestinal failure which may help other children treated with cycled PN in the future
Detailed Description:
The objective of this investigation is to quantify dysglycemia associated with cycled parenteral nutrition PN and elevated glucose infusion rates GIR in infants with intestinal failure and PN-dependence leveraging high-frequency continuous glucose monitor CGM sensor glucose values in a prospective observational study
Intestinal failure is a malabsorptive state which necessitates PN in its most severe form PN is ideally transitioned from continuous 24 hrday to cycled PN 24 hrday requiring higher glucose infusion rates GIR to provide the same nutrition content over a shorter time-period Patients on cycled PN especially infants are vulnerable to dysglycemia abnormal glucose levels specifically hyperglycemia during PN infusions due to inadequate insulin relative to high GIR and hypoglycemia when PN is cycled off due to delayed insulin suppression after PN suspension There is no established pediatric GIR threshold above which the risk of abnormal glucose levels significantly increases
While current practice relies on intermittent blood glucose checks continuous glucose monitors CGM measure high-frequency glucose profiles via minimally-invasive sensors and are capable of precisely detecting clinically-actionable trends that may otherwise go unrecognized The CGM sensor measures interstitial glucose an accepted proxy for blood glucose in patients 2 years old with diabetes or glycemic variability CGM has been successfully used in infants and can fulfill the need for greater quantitative insight into glucose trends in metabolically and neurologically fragile populations including infants with intestinal failure
The investigators hypothesize that during high-GIR cycled PN a trough glucose while PN is suspended is less than normal statistically defined as 100 mgdL and b average glucose while receiving the target highest GIR is greater than normal statistically defined as 120 mgdL
Eligible infants will be identified among hospitalized infants at Boston Childrens Hospital and followed by the Home Parenteral Nutrition HPN program and the Center for Advanced Intestinal Rehabilitation CAIR All enrolled participants will have a Dexcom G6 Pro CGM placed within 1 week prior to the anticipated initiation of PN cycling and CGM will be worn using blinded mode for up to 30 days until target GIR cycled PN is reached 3 sensors maximum If target GIR cycled PN is not reached following 3 sensor periods up to 10 days per sensor the parentguardian will be approached to accept or decline participation in an optional extension phase In the extension phase the primary study will be repeated and CGM monitoring will continue until target GIR cycled PN is reached up to an additional 3 sensor placements No CGM will remain in place at the time of discharge
The CGM readings will remain blinded to the clinical staff members no real-time CGM alerts will be provided to the clinical staff The clinical team will manage PN cycling and clinical blood glucose monitoring as per routine clinical practice Chart review will occur throughout the study period to abstract necessary information about the participants medical history and interval clinical events
An initial CGM data review will be conducted by the research team within 72 hours of each sensor removal The clinical team will be notified if there were intervals meeting the criteria of sustained sensor readings 50 mgdL for greater than or equal to 15 minutes The clinical team will be provided with the criteria for notification the datetime stamps associated with those events and information about interpreting CGM readings We will provide this limited information to the clinical team because sustained CGM sensor readings 50 mgdL may signify that the participant is at increased risk for hypoglycemia blood glucose 70 mgdL on cycled PN The study protocol does not require any blood glucose measurements or other clinical interventions
Intestinal failure is a malabsorptive state which necessitates PN in its most severe form PN is ideally transitioned from continuous 24 hrday to cycled PN 24 hrday requiring higher glucose infusion rates GIR to provide the same nutrition content over a shorter time-period Patients on cycled PN especially infants are vulnerable to dysglycemia abnormal glucose levels specifically hyperglycemia during PN infusions due to inadequate insulin relative to high GIR and hypoglycemia when PN is cycled off due to delayed insulin suppression after PN suspension There is no established pediatric GIR threshold above which the risk of abnormal glucose levels significantly increases
While current practice relies on intermittent blood glucose checks continuous glucose monitors CGM measure high-frequency glucose profiles via minimally-invasive sensors and are capable of precisely detecting clinically-actionable trends that may otherwise go unrecognized The CGM sensor measures interstitial glucose an accepted proxy for blood glucose in patients 2 years old with diabetes or glycemic variability CGM has been successfully used in infants and can fulfill the need for greater quantitative insight into glucose trends in metabolically and neurologically fragile populations including infants with intestinal failure
The investigators hypothesize that during high-GIR cycled PN a trough glucose while PN is suspended is less than normal statistically defined as 100 mgdL and b average glucose while receiving the target highest GIR is greater than normal statistically defined as 120 mgdL
Eligible infants will be identified among hospitalized infants at Boston Childrens Hospital and followed by the Home Parenteral Nutrition HPN program and the Center for Advanced Intestinal Rehabilitation CAIR All enrolled participants will have a Dexcom G6 Pro CGM placed within 1 week prior to the anticipated initiation of PN cycling and CGM will be worn using blinded mode for up to 30 days until target GIR cycled PN is reached 3 sensors maximum If target GIR cycled PN is not reached following 3 sensor periods up to 10 days per sensor the parentguardian will be approached to accept or decline participation in an optional extension phase In the extension phase the primary study will be repeated and CGM monitoring will continue until target GIR cycled PN is reached up to an additional 3 sensor placements No CGM will remain in place at the time of discharge
The CGM readings will remain blinded to the clinical staff members no real-time CGM alerts will be provided to the clinical staff The clinical team will manage PN cycling and clinical blood glucose monitoring as per routine clinical practice Chart review will occur throughout the study period to abstract necessary information about the participants medical history and interval clinical events
An initial CGM data review will be conducted by the research team within 72 hours of each sensor removal The clinical team will be notified if there were intervals meeting the criteria of sustained sensor readings 50 mgdL for greater than or equal to 15 minutes The clinical team will be provided with the criteria for notification the datetime stamps associated with those events and information about interpreting CGM readings We will provide this limited information to the clinical team because sustained CGM sensor readings 50 mgdL may signify that the participant is at increased risk for hypoglycemia blood glucose 70 mgdL on cycled PN The study protocol does not require any blood glucose measurements or other clinical interventions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None