The purpose of this trial is to test and refine the PACTAID smart phone application in adults with type 1 diabetes mellitus to help manage exercise while on automated insulin delivery systems with the goal of improving glycemic control during and after exercise as well as improving multiple other cardiovascular risk factors.
This trial will be conducted in two phases. In Phase 1, we will test the PACTAID app in adults with type 1 diabetes mellitus to help manage exercise while on an automated insulin delivery system for four weeks. In phase 2, we will use a refined version of the PACTAID app in those same adults from phase 1 for four weeks. A 2-4-week period will be between phase 1 and phase 2 in which the app will be refined. There is one clinical site, Mayo Clinic, and two sites creating the app, Arizona State University and University of Houston. The study will enroll up to 8 subjects at Mayo Clinic.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
20
The PACTAID app will provide real time decision support during exercise for patients with type 1 diabetes.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Mean CGM glucose (mg/dL)
Change in mean CGM glucose (mg/dL)
Time frame: Baseline, 4 weeks, 8 weeks
CGM glucose SD (mg/dL)
Change in CGM glucose SD (mg/dL)
Time frame: Baseline, 4 weeks, 8 weeks
Glucose coefficient of variation (%)
Change in glucose coefficient of variation (%)
Time frame: Baseline, 4 weeks, 8 weeks
CGM TIR (70-180mg/dL)
Change in CGM TIR (70-180mg/dL)
Time frame: Baseline, 4 weeks, 8 weeks
CGM TBR (<70 and <54 mg/dL)
Change in CGM TBR (\<70 and \<54 mg/dL)
Time frame: Baseline, 4 weeks, 8 weeks
CGM TAR (>180 and >250 mg/dL)
Change in CGM TAR (\>180 and \>250 mg/dL)
Time frame: Baseline, 4 weeks, 8 weeks
Adherence to exercise
Data will be collected via the PACTAID app, which will generate reports on the number of exercise sessions logged by patients. Since participants will also be wearing a Fitbit watch, we will capture heart rate changes during exercise, which will help confirm their physical activity. Furthermore, participants will complete the International Physical Activity Questionnaire (IPAQ) approximately once a month throughout the study.
Time frame: Baseline, 8 weeks
CGM hypoglycemic events
Frequency of CGM measured Hypoglycemic events
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Time frame: Baseline, 8 weeks
Severe hypoglycemia
Frequency of severe hypoglycemia (requiring assistance from another person to recover from hypoglycemia)
Time frame: Baseline, 8 weeks
Ambulatory blood pressure
Change in ambulatory blood pressure
Time frame: Baseline, 8 weeks
Ambulatory Arterial Stiffness Index
Change in ambulatory arterial stiffness Index
Time frame: Baseline, 8 weeks
HsCRP
Change in HsCRP
Time frame: Baseline, 8 weeks
Body weight or BMI
Change in body weight or BMI
Time frame: Baseline, 8 weeks