Testing and Refinement of PACTAID App in Patients With Type 1 Diabetes to Help Manage Exercise While on Automated Insulin Delivery System
Mayo Clinic
Summary
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.
Description
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or Female between age of 18-65 yrs. * T1D diagnosis will be confirmed by C- Peptide (≤0.6 ng/ml) with a simultaneous fasting glucose concentration 80-225 mg/dL. * T1D using AID either tandem Control IQ, Medtronic 780G, Omnipod 5 or Ilet bionic pancreas for diabetes management at the time of screening for at least 3-month duration. * CGM and insulin pump data available for \> 70% for last 2 weeks. * T1D without atherosclerotic cardiovascular disease * HbA1c ≤10 % * Able to understand English language. * Currently using an insulin-to-carbohydrate ratio to calculate me…
Interventions
- DevicePACTAID App
The PACTAID app will provide real time decision support during exercise for patients with type 1 diabetes.
Location
- Mayo Clinic in RochesterRochester, Minnesota