Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06730906

PACTAID App in Adults With Type 1 Diabetes to Help Manage Exercise

Led by Mayo Clinic · Updated on 2026-01-07

20

Participants Needed

1

Research Sites

102 weeks

Total Duration

On this page

Sponsors

M

Mayo Clinic

Lead Sponsor

A

Arizona State University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

PACTAID App in Adults With Type 1 Diabetes to Help Manage Exercise

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or Female between age of 18-65 years
  • Confirmed diagnosis of type 1 diabetes by C-Peptide ≤0.6 ng/ml with fasting glucose 80-225 mg/dL
  • Using automated insulin delivery (AID) system (Tandem Control IQ, Medtronic 780G, Omnipod 5, or Ilet bionic pancreas) for at least 3 months
  • Continuous glucose monitoring (CGM) and insulin pump data available for >70% of the last 2 weeks
  • No atherosclerotic cardiovascular disease
  • HbA1c ≤10%
  • Able to understand English
  • Using an insulin-to-carbohydrate ratio for meal bolus calculation
  • Willing to complete study procedures and wear study devices
  • Understands and agrees to follow the protocol, including performing all 3 types of exercises
  • Non-smoker
  • Satisfactory EKG within last year or at screening if not previously available
Not Eligible

You will not qualify if you...

  • Use of anti-hyperglycemic drugs other than insulin, including metformin
  • Pregnant or planning pregnancy during study
  • Untreated hyperthyroidism or hypothyroidism with abnormal TSH at screening
  • Severe hypoglycemia or diabetic ketoacidosis in last 3 months
  • Engaging in vigorous exercise such as 1 hour per day
  • Body mass index (BMI) ≥35 kg/m2
  • Uncontrolled obstructive sleep apnea on CPAP
  • Chronic obstructive pulmonary disease
  • Asthma limiting exercise
  • Uncontrolled hypertension (blood pressure ≥140/90 mmHg with ≥2 medications)
  • Clinically diagnosed obstructive coronary artery disease or significant cardiac conditions
  • Uncontrolled or recurrent ventricular tachycardia
  • Use of medications affecting heart rate
  • Unstable proliferative diabetic retinopathy
  • Previous organ transplant
  • Receiving chemotherapy or long-term immunosuppressant therapy
  • COVID-19 positive at screening
  • Clinically diagnosed autonomic neuropathy
  • Abnormal liver function tests (transaminase >3 times upper limit)
  • Abnormal renal function (calculated GFR <60 mL/min/1.73m2)
  • Active gastroparesis
  • Alcohol or recreational drug abuse
  • Ongoing infectious process expected to delay study procedures
  • Unstable on antidepressants in past 2 months
  • Any medical condition judged by investigator to interfere with study completion, including recent psychiatric inpatient treatment, adrenal disorders, recent injury or illness, participation in other treatment studies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

C

Corey Kurek

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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