The goal of this clinical trial is to obtain safety data and exploratory glycemic control data from use of an at-home closed loop control (CLC) system (t:slim X2 with Control-IQ Technology) with periodic parameter adjustments driven by an AI-based Advisor system in young children with Type 1 Diabetes. The main endpoints this study aims to answer is the safety and efficacy of the use of the AI-driven pump parameters. Participants will use the study system (pump and Continuous Glucose Monitor) in closed-loop mode for eight weeks.
In this single-arm pilot study of an AI Advisor-driven closed loop system initiation and parameter adaptation in youth age 2 to \<6 years old, participants will use the Tandem t:slim X2 with Control-IQ and t:connect mobile application and Dexcom G6 or G7 system, connected to the University of Virginia (UVA) cloud-based Physician Dashboard for eight weeks at home.The key safety outcomes are adverse events related to hypoglycemia and hyperglycemia, CGM-measured time spent below 54mg/dL, and CGM-measured time spent above 250 mg/dL. CGM-measured endpoints will be tested against baseline for non-inferiority.Glycemic outcomes including time in target range 70-180 mg/dL (TIR) and various other CGM measures of hypo- and hyperglycemia will be assessed and tested for superiority against baseline and a matched historical control population from the prior PEDAP study that did not involve the use of any AI-driven pump parameters. Up to 45 screened participants with the goal of at least 30 participants completing the study pump use period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Tandem t:slim X2 with Control-IQ and t:connect mobile application and Dexcom G6 or G7 system, connected to UVA cloud-based Physician Dashboard with insulin pump parameters driven by an AI-based Advisor system.
Stanford University
Stanford, California, United States
Barbara Davis Center, University of Colorado
Aurora, Colorado, United States
University of Virginia
Charlottesville, Virginia, United States
Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (a)
% of time below 54 mg/dL
Time frame: Baseline and Weeks 1-8
Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (b)
% of time above 250 mg/dL
Time frame: Baseline and Weeks 1-8
Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (a)
% of time in range 70-180 mg/dL
Time frame: Baseline and Weeks 1-8
Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (b)
Mean glucose
Time frame: Baseline and Weeks 1-8
Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (c)
% of time \>250 mg/dL
Time frame: Baseline and Weeks 1-8
Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (d)
% of time \<70 mg/dL
Time frame: Baseline and Weeks 1-8
Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (e)
% of time \<54 mg/dL
Time frame: Baseline and Weeks 1-8
CGM Measured Time in Range
% of time spent within range 70 mg/dL-140 mg/dL.
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Time frame: Baseline and Weeks 1-8
CGM Measured (a)
% of time \>180 mg/dL
Time frame: Baseline and Weeks 1-8
CGM Measured (b)
% of time \>300 mg/dL
Time frame: Baseline and Weeks 1-8
CGM Measured (c)
% of time \<60 mg/dL
Time frame: Baseline and Weeks 1-8
CGM Measured (d)
Glucose standard deviation
Time frame: Baseline and Weeks 1-8
CGM Measured (e)
Glucose coefficient of variation
Time frame: Baseline and Weeks 1-8
CGM Measured (f)
The high blood glucose index (HBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values below 10 suggest low to moderate risk.
Time frame: Baseline and Weeks 1-8
CGM Measured (g)
The low blood glucose index (LBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values \<1 suggest low risk of hypoglycemia.
Time frame: Baseline and Weeks 1-8
CGM Measured (h)
Weekly hyperglycemic event rate
Time frame: Baseline and Weeks 1-8
CGM Measured (i)
Weekly hypoglycemic event rate
Time frame: Baseline and Weeks 1-8
Binary Outcome 1
Number of participants whose % of time in range 70-180 mg/dL improved by 5% or more from baseline to 8 weeks.
Time frame: Baseline and Weeks 1-8
Binary Outcome 2
Number of participants whose % of time in range 70-180 mg/dL improved by 10% or more from baseline to 8 weeks.
Time frame: Baseline and Weeks 1-8
Binary Outcome 3
Participants with % of time in range 70-180 mg/dL \>70% and % of time \<70 mg/dL \<4%
Time frame: Baseline and Weeks 1-8
Total Daily Insulin
Total daily insulin (units/kg)
Time frame: Baseline and Weeks 1-8
Basal Insulin
Percentage of total insulin delivered via basal administration.
Time frame: Baseline and Weeks 1-8