Clinical trial NCT01767831: Evaluation of a Simulation-Based Educational Tool for Personalized Feedback in Insulin Therapy Management
Official title: Evaluation of a Simulation-Based Educational Tool for Personalized Feedback in Insulin Therapy Management
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 Diabetes Mellitus (T1DM)
Continuous Glucose Monitor (CGM)
Simulation-based Education
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2013-01-14
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type 1 Diabetes Mellitus study subjects that are currently identified in the Center for Diabetes Technology recruitment database. Subject be currently wearing an insulin pump for at least 6 months and must have worn a continuous glucose monitor for at least 6 weeks during the past 2 years.

Brief summary: 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.

Detailed description: Development of an insulin delivery educational tool in T1DM requires fundamental behavioral and physiology studies, as well as translational modeling and engineering development. In order to be successful, Closed Loop Control (CLC) in T1DM must adapt to individual physiologic characteristics and to the behavioral profile of each person. Here, we have laid the foundation by testing an educational tool that aims at providing feedback to patients with the goal of optimizing patient's glucose control under conventional insulin therapy. This educational tool is based on collecting data from patients that are processed by algorithms giving insight into the relationship between glucose control and psychobehavioral characteristics of the individual. This information will eventually inform a CLC system, which will be initialized for each individual based on relevant behavioral and physiologic characteristics, and will include algorithmic observers of patients' behavior and metabolic state.

Eligibility criteria: Inclusion Criteria:

For this pilot trial, recruitment will ONLY occur through UVa's IRB-HSR #14263 Recruitment Database.

Inclusion criteria for subject to enroll:

1. T1DM (as defined by the American Diabetes Association criteria or judgment of a physician) for at least 2 years prior to the enrollment in the study
2. Age 21-65.
3. Use of an insulin pump to treat their diabetes for at least 6 months.
4. Use of a CGM for at least a 6 week period in the past 2 years.
5. Has the ability to use a computer that is capable of running the Dexcom Data Manager 3 (DM3) software daily.
6. Has regular access to the Internet.
7. Has an identified healthcare provider who can provide advice about diabetes care.
8. Actively using a bolus calculator function with the current insulin pump with pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor.
9. Willingness to participate in the study for 11 weeks wearing a DexCom CGM for the duration of the study and perform daily journaling of BG, pump activity, meals, physical activity, stress level and menstrual cycle for 3 weeks during the study intervention period.
10. Willingness to do extra fingersticks when CGM alarms at low or high end (\<70 mg/dl or \>300 mg/dl),
11. Willingness to come to Center for Diabetes Technology on at least two occasions to obtain and return supplies.
12. Willingness to avoid consumption of acetaminophen-containing products for the duration of the study.
13. Demonstration of proper mental status and cognition for completion of the study.
14. Has the ability to contact their own personal diabetes care team to have clinical questions answered about changes to diabetes treatment.

Exclusion Criteria:

1. Individuals with cognitive impairment that prevents understanding either consent form or intervention content
2. Active renal dialysis
3. Psychiatric disorders that would interfere with study tasks (e.g., substance abuse)
4. History of a systemic deep tissue infection with methicillin-resistant staph aureus or Candida albicans
5. Known bleeding diathesis or dyscrasia
6. Pregnant or intending to get pregnant during study
7. Active enrollment in another clinical trial
8. Medical requirement for acetaminophen-containing products during the study period for more than 1 week
9. Medical condition that would make operating a CGM or insulin pump difficult (e.g. blindness, severe arthritis, extensive scar tissue at sites where devices are inserted)
10. Individuals who do not have access to their diabetes care team to have clinical questions answered about changes in their diabetes treatment.
11. Need for magnetic resonance imaging (MRI)/magnetic resonance angiogram (MRA)during the study

List any restrictions on use of other drugs or treatments:

The CGM must be removed prior to Magnetic Resonance Imaging and use of acetaminophen-containing medications while using the CGM sensor may affect the performance of the device. Therefore, MRI and products containing acetaminophen will be restricted. If either is required out of medical necessity, the DexCom® will be removed and participant will have the option of repeating the involved study week. If the medical condition requires use of acetaminophen for longer than 1 week, the participant will be dropped from the study.

Primary outcomes:
measure: Accuracy of Feedback and Intervention Feasibility
timeFrame: within 6 months of study conclusion
measure: Ability of Behavioral Intervention to Improve Glycemic Outcome
timeFrame: within 6 months of study conclusion
Secondary outcomes:
measure: Psychobehavioral Data to Inform Closed Loop Control Aggressiveness
timeFrame: within 1 year of study conclusion
measure: Relationships Between Physiology and Behavior Transferred to In Silico Environment
timeFrame: within 2 years from study conclusion
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Center for Diabetes Technology
state: Virginia
Study officials:
affiliation: University of Virginia Center for Diabetes Technology
name: Linda Gonder-Fredrick, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: