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

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.