Testing and Refinement of PACTAID App in Patients With Type 1 Diabetes to Help Manage Exercise While on Automated Insulin Delivery System

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• 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 meal bolus sizes.

• Willing to complete study procedures.

• Willing to wear study devices.

• An understanding of and willingness to follow the protocol, perform all 3 types of exercises as per protocol, and sign the informed consent.

• Non-smoker

• Satisfactory EKG in last one year or if not available, satisfactory baseline EKG at screening

Locations
United States
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Contact Information
Primary
Corey Kurek
reid.corey@mayo.edu
507-255-0316
Time Frame
Start Date: 2025-01-10
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 8
Treatments
Experimental: Intervention Group
Participants will utilize the PACTAID app for 8 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: University of Houston, Arizona State University
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov