The purpose of this pilot study is to test the safety and feasibility of using two or three research modules in conjunction with an automated insulin delivery device (AID).
This concept is implemented in the Adaptive Biobehavioral Control (ABC) system - ABC will use human-machine co-adaptation of AID, recognizing both the necessity for the control algorithm to adapt to changes in human physiology, and the necessity for the person to adapt to AID action. ABC will be implemented on the Web Information Tool (WIT) platform/system and includes the following modules to be used alongside the automated insulin delivery device facilitating behavioral adaptation: * Behavioral Adaptation Module (BAM) - a behavioral intervention deployed in a mobile app to assist a person's adaptation to automated insulin delivery by information and risk assessment primarily regarding glycemic risks, and * Auto Titration Module (ATM) - a web-based tool with an automated procedure to track risk status and changes in the participant's metabolic profile. This module will present updated insulin control parameters to the user once a week using a web-based format accessible to the participant. * Web-based Simulation Tool (WST) --a web-based education tool for participants to interact with their data to visualize and replay various scenarios to understand the impact of insulin parameter changes. Design: Two-week baseline use of personal AID system followed by randomization 1:1 into two groups. * Group 1 will use their personal AID system and add an auto titration module (ATM) and web simulation tool (WST) in which insulin parameters may be adjusted on a weekly basis. * Group 2 will use their personal AID system and add the ATM / WST on a weekly basis as well as a behavioral adaptation module (BAM). The BAM will consist of information modules in which information only is given to participants (e.g. hypoglycemic risks).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action.
BAM provides on-demand information to the participant primarily on glycemic risks.
ATM provides recommendations to the participant to periodically update insulin parameters.
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States
Number of SAE or ADE Related to the Use of ATM / WST and BAM Modules.
Safety assessment of ATM / WST and BAM modules by assessing serious adverse events or adverse device effects deemed related to the use of ATM/WST and BAM modules specifically.
Time frame: 6 weeks
Time in Range
Percent of CGM readings in the target ranges of 70-180mg/dL from 2 weeks of baseline compared to last 2 weeks of treatment period.
Time frame: 6 weeks
Time in Hypoglycemia
Percent of CGM readings \<70 mg/dL
Time frame: 6 weeks
INSPIRE Questionnaire
Questionnaire addressing system/technology use. The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Adult survey has 22 items.
Time frame: 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study.