This study is intended to test a Web-based Information Tool (WIT) software providing additional information regarding time in range, GMI, hypo- and hyperglycemia risks, variability tracker, daily glycemic profiles, and potential changes of insulin pump parameters, to users of a commercially available Closed-Loop Control (CLC) System (Control-IQ Technology).
This is a randomized two-arm crossover group trial in which both groups will use the CLC (Control-IQ) plus WIT. The difference between the two groups will be the order of the interventions. Each group will undergo screening and collection of baseline data from their personal AID system (Control-IQ) followed by randomization 1:1 into two groups. Both groups will have the same three interventions but will progress in the study in a different order allowing for crossover comparisons. The three interventions are: * Use of personal CLC system for 2 weeks * Use of personal CLC system and adding a behavioral adaptation module (BAM) for 4 weeks * Use of personal CLC system and adding the ABC which includes: BAM and PAM (which includes ATM and WST described below) for 16 weeks. The BAM will consist of modules in which information only is given to participants (e.g. time in range, Glucose Management Indicator (GMI), hyper-and hypoglycemic risks, daily glycemic profiles, and variability tracker). The PAM includes auto suggestions for titration of insulin pump parameters every two weeks (ATM) and is aided by a web simulation tool (WST) which can replay 'what if' scenarios for the participant based on various combinations of insulin pump parameter changes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States
CGM-measured percent time in range 70-180 mg/dL
The primary outcome for this study is CGM-measured percent time in range 70-180 mg/dL over the last 4-week periods on CLC+ABC versus 2 weeks of the current CLC system. The intervention will be considered effective if the CLC+ABC is superior to the CLC alone in a crossover design using a statistical significance of α=0.05. To preserve the overall type 1 error for selected key secondary endpoints, a hierarchical testing procedure will be used. If the primary analysis for time in range described above results in a statistically significant result (p \< 0.05), then testing (similar to the model for the primary outcome) will proceed to the next key secondary outcome metric in the following order entered.
Time frame: 4 weeks
CGM-measured percent above 180 mg/dL during the day
A key secondary outcome is CGM-measured percent above 180mg/dL during the day comparing last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone. If the analysis results in a statistically significant result (p \< 0.05), then testing will proceed to the next secondary outcome metric in the following order entered.
Time frame: 4 weeks
CGM-measured percent below 70 mg/dL during the day
A key secondary outcome is CGM-measured percent below 70 mg/dL during the day comparing last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone. If the analysis results in a statistically significant result (p \< 0.05), then testing will proceed to the next secondary outcome metric in the following order entered.
Time frame: 4 weeks
CGM-measured mean glucose
A key secondary outcome is CGM-measured mean glucose comparing the last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone. If the analysis results in a statistically significant result (p \< 0.05), then testing will proceed to the next secondary outcome metric in the following order entered.
Time frame: 4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CGM-measured coefficient of variation during the day
A key secondary outcome is CGM-measured percent coefficient of variation during the day comparing last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone.
Time frame: 4 weeks