Trial Outcomes & Findings for Hybrid Closed-Loop Control With Smart Prandial Insulin Dosing in Type 1 Diabetes (NCT NCT04878120)

Last Updated: 2024-05-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

25 participants

Primary outcome timeframe

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)

Results posted on

2024-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	Standard HCL System - HCL System With Smart Bolus Calculator Use of standard HCL system followed by use of HCL system with smart bolus calculator informed by insulin sensitivity Standard HCL System: Standard HCL system (USS Virginia) HCL System with Smart Bolus Calculator: HCL system (USS Virginia) with smart bolus calculator informed by insulin sensitivity	HCL Control With Smart Bolus Calculator - Standard HCL Control Use of HCL system with smart bolus calculator informed by insulin sensitivity followed by use of standard HCL system Standard HCL System: Standard HCL system (USS Virginia) HCL System with Smart Bolus Calculator: HCL system (USS Virginia) with smart bolus calculator informed by insulin sensitivity
Overall Study STARTED	13	12
Overall Study COMPLETED	12	11
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hybrid Closed-Loop Control With Smart Prandial Insulin Dosing in Type 1 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard HCL Control - HCL Control With Smart Bolus Calculator n=12 Participants Use of standard HCL system followed by use of HCL system with smart bolus calculator informed by insulin sensitivity	HCL Control With Smart Bolus Calculator - Standard HCL Control n=11 Participants Use of HCL system with smart bolus calculator informed by insulin sensitivity followed by use of standard HCL system	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	13.8 years STANDARD_DEVIATION 1.7 • n=5 Participants	14.6 years STANDARD_DEVIATION 1.3 • n=7 Participants	14.2 years STANDARD_DEVIATION 1.6 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Hemoglobin A1c	7.2 % STANDARD_DEVIATION 0.4 • n=5 Participants	7.2 % STANDARD_DEVIATION 0.8 • n=7 Participants	7.2 % STANDARD_DEVIATION 0.6 • n=5 Participants

PRIMARY outcome

Timeframe: 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)