CAMP: CGM-Assisted Management of PN
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Trough glucose while PN is suspended
研究概览
简要总结
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 parent/guardian 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. CGM may provide false low glucose readings when the tissue around the sensor is compressed (compression lows), such as when laying on the sensor during sleep. We will generate data during the study to help identify and filter the final dataset to remove likely compression lows.
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.
详细描述
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 hr/day) to cycled PN (<24 hr/day), 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 mg/dL), and b) average glucose while receiving the target (highest) GIR is greater than normal (statistically defined as 120 mg/dL).
Eligible infants will be identified among hospitalized infants at Boston Children's 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 parent/guardian 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of intestinal failure with PN dependence
- •Hospitalized at Boston Children's Hospital
- •Age: 60 days to 18 months
- •Corrected gestational age: greater than or equal to 40 weeks
- •Weight: greater than or equal to 4kg
- •Likely to proceed to PN cycling within the next month, as assessed by the clinical team
排除标准
- •Underlying medical conditions or medications that predispose to hypoglycemia or hyperglycemia (e.g. insulin administration, systemic glucocorticoids, hyperinsulinism, adrenal insufficiency, other metabolic diseases)
- •Diffuse skin disease such that placement of a CGM sensor would be unsafe or difficult to secure
- •Known history of allergy or severe reaction to the adhesive/tape that is used to secure the CGM
- •Diffuse body edema that would limit accuracy of CGM sensor
- •Poor peripheral perfusion or use of vasoactive agents that would limit accuracy of CGM sensor
- •Use of medications that interfere with CGM accuracy (e.g. Hydroxyurea, acetaminophen at more than a maximum dose of 1 g every 6 hours up to 4 g every 24 hours)
- •Enrolled in competing clinical trial
- •Ward of the state
结局指标
主要结局
Trough glucose while PN is suspended
时间窗: Through study completion, up to 30 days
For each subject, "trough glucose" will be defined as the lowest sensor glucose value, during the entire study period, that occurs while PN is suspended.
Average glucose while receiving the target GIR
时间窗: Through study completion, up to 30 days
For each subject, "average glucose" will be defined as an average of all sensor glucose values recorded while receiving the target GIR. "Target GIR" will be defined as the final GIR prior to discharge home, or highest GIR given during the study period if clinical goal GIR is not reached during the study period.
次要结局
- Measures of dysglycemia(Through study completion, up to 30 days)
研究者
Michael Agus
Division Chief, Medical Critical Care
Boston Children's Hospital