The objective of this study is to evaluate the safety and feasibility of a smart bolus calculator that adjusts insulin dosing for meals according to real-time insulin sensitivity (SI) in adolescents with type 1 diabetes (T1D) using a hybrid closed loop (HCL) system during an active week of diabetes camp.
This is a single center, double-blind, randomized, crossover trial. The study team will target enrollment of 30 adolescents (age 12 - \<18 years) with T1D who currently manage their diabetes with an insulin pump and a continuous glucose monitoring (CGM) system. Participants will be randomized 1:1 to the use of the standard HCL system (USS Virginia) vs. the HCL system with the smart bolus calculator first. The trial will be held at a local camp facility and will consist of EITHER a weeklong (6 day/5 night) camp OR two long weekends (4 day/3 night) separated by a washout period of about one week.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
25
Standard HCL system (USS Virginia)
HCL system (USS Virginia) with smart bolus calculator informed by insulin sensitivity
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States
Low Blood Glucose Index (LBGI)
LBGI computed from CGM collected in the four hours following the dinner meal. LBGI is a metric quantifying the risk for hypoglycemia (the higher the LBGI, the higher the exposure to/risk of hypoglycemia), calculated based on the following two steps: 1. Transforming each CGM reading in the time-series of length N into a hypoglycemia risk score (rL(i), i=1,...,N) by applying the following transformation: rL(i) = 10 x (1.509 x (log(CGM(i))\^1.084 - 5.381))\^2, if CGM(i) \<=112.5 mg/dL; rL(i) = 0, if CGM(i) \>112.5 mg/dL 2. Averaging the risk scores rL(i), i=1,...,N. The hypoglycemia risk score ranges from 0 for CGM readings \>112.5 mg/dL (no hypoglycemia risk) to 100 for CGM readings =20 mg/dL (maximum hypoglycemia risk); consequently, LBGI can theoretically assume values between 0 and 100 as well. Clinically relevant LBGI thresholds have been defined: 1. LBGI \<2.5: low hypoglycemia risk 2. LBGI in 2.5-5: moderate hypoglycemia risk 3. LBGI \>5: high hypoglycemia risk.
Time frame: 4 hours (dinner postprandial period); the final metric for each intervention type is obtained as the average over two consecutive camp days (days 1-2 for the first intervention; days 3-4 for the second intervention)
Percentage of Time Spent Below 70 mg/dL
Percentage of CGM readings in hypoglycemia below 70 mg/dL
Time frame: 4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome
Percentage of Time Spent in 70-180 mg/dL
Percentage of CGM readings in normoglycemia between 70-180 mg/dL
Time frame: 4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome
Percentage of Time Spent Above 180 mg/dL
Percentage of CGM readings in hyperglycemia above 180 mg/dL
Time frame: 4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome
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High Blood Glucose Index (HBGI)
HBGI computed from CGM collected in the four hours following the dinner meal. HBGI is a metric quantifying the risk for hyperglycemia (the higher the HBGI, the higher the exposure to/risk of hyperglycemia), calculated based on the following two steps: 1. Transforming each CGM reading in the time-series of length N into a hyperglycemia risk score (rH(i), i=1,...,N) by applying the following transformation: rH(i) = 10 x (1.509 x (log(CGM(i))\^1.084 - 5.381))\^2, if CGM(i) \>112.5 mg/dL; rH(i) = 0, if CGM(i) \<=112.5 mg/dL 2. Averaging the risk scores rH(i), i=1,...,N. The hyperglycemia risk score ranges from 0 for CGM readings \<=112.5 mg/dL (no hyperglycemia risk) to 100 for CGM readings =600 mg/dL (maximum hyperglycemia risk); consequently, HBGI can theoretically assume values between 0 and 100 as well. Clinically relevant HBGI thresholds have been defined: 1. HBGI \<4.5: low hyperglycemia risk 2. HBGI in 4.5-9: moderate hyperglycemia risk 3. HBGI \>9: high hyperglycemia risk.
Time frame: 4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome
CGM Coefficient of Variation
CGM coefficient of variation as a measure of glucose variability
Time frame: 4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome
Total Amount of Carbohydrate Administered as Rescue Treatments
Total amount of carbohydrate administered as rescue treatments per study protocol
Time frame: 4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome