Evaluation of a Simulation-Based Educational Tool for Personalized Feedback in Insulin Therapy Management

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study combines data collection and simulation-based education, and it will enroll up to 36 adults with T1DM who already have experience with insulin pump therapy and some experience with a continuous glucose monitor (CGM). The study will first track participants for of a 3-day CGM-training period. The training period will be followed by a 1-week CGM monitoring and CGM data collection period. Following the 1-week CGM monitoring-only portion of the study, participants will begin the education intervention component of the study, referred to as Insight-Based Online Learning Using Simulation and Education for Diabetes (iBOLUSED). The education intervention component is 4 weeks in length. The intervention will involve daily diary data upload and daily simulation-based feedback based on the collected diary data. During the first week (and for up to 2 weeks) of the intervention, participants will view glycemic outcome data that represents the participant's hypo- and hyperglycemic risk throughout the day, based on the CGM data collected during the CGM monitoring period. In the next 2 weeks of the intervention, participants will have an opportunity to interact with the internet-based system using a simulation-based tool designed to provide insight to the participant regarding the different effects of modifications to insulin therapy. Throughout the educational intervention, participants will record diary data every day through the use of a diary component in the internet-based system. Diary entries include data on meals, physical activity, history of the insulin basal rate and insulin boluses given that day, self-reported stress level, hypo- and hyperglycemic fear levels, and, if applicable, menstrual cycle and any physical illness. Participants will also upload data from the CGM via the Dexcom Data Manager 3 (DM3) software or the Dexcom Studio Software. Two assessments, one prior to the intervention period and one following the intervention, will be administered to gather relevant psychobehavioral information. Focus group sessions will be conducted at the end of the study, which will allow for the collection of information regarding the effectiveness of the Internet intervention and will provide insight for the design of future studies. Parallel recording of CGM, insulin, and behavioral data, as well as psychometric instruments, will produce a rich synchronized data set for each person that will facilitate the development of personalized behavioral profiles that will be employed to provide individualized feedback to educate participants. In particular, this study tests the use of collected diary data to educate participants by describing glucose profile information and presenting relevant data regarding: (1) hypo- and hyperglycemia risk zones throughout the day, (2) insulin meal bolus information and associated glycemic outcome indices, and (3) basal rate information with associated glycemic outcome indices.

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Last update posted Apr 27, 2014 · Synced Sep 3, 2026

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